Trial Outcomes & Findings for Enhancing Medication-based Analgesia in Humans (NCT NCT02901275)

NCT ID: NCT02901275

Last Updated: 2023-11-07

Results Overview

Compare study conditions in seconds to withdraw hand from cold pressor laboratory pain task, where longer time periods reflect higher tolerance to pain.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 29 participants
• Primary outcome timeframe: Baseline and time of hand withdrawal from cold pressor, up to 60 seconds
• Results posted on: 2023-11-07

Participant Flow

This is a within-subject study, and all participants (n=29) completed all study conditions. The same 29 participants moved from one treatment arm to the next.

Participant milestones

Measure	Full Participant Sample Each participant completed the following five study conditions (arms) in randomized order: Placebo + Placebo condition Hydromorphone (oral) 4mg + placebo condition Hydromorphone (oral) 4mg + Dronabinol (oral) 2.5mg condition Hydromorphone (oral) 4mg + Dronabinol (oral) 5mg condition Hydromorphone (oral) 4mg + Dronabinol (oral) 10mg condition
Overall Study STARTED	29
Overall Study Placebo + Placebo	29
Overall Study Hydromorphone (Oral) 4mg + Placebo	29
Overall Study Hydromorphone (Oral) 4mg + Dronabinol (Oral) 2.5mg	29
Overall Study Hydromorphone (Oral) 4mg + Dronabinol (Oral) 5mg	29
Overall Study Hydromorphone (Oral) 4mg + Dronabinol (Oral) 10mg	29
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enhancing Medication-based Analgesia in Humans

Baseline characteristics by cohort

Measure	All Participants n=29 Participants This is a within group study and same participants went through all treatment arms.
Age, Continuous	30.4 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and time of hand withdrawal from cold pressor, up to 60 seconds

Compare study conditions in seconds to withdraw hand from cold pressor laboratory pain task, where longer time periods reflect higher tolerance to pain.

Outcome measures

Measure	Placebo + Placebo Condition n=29 Participants Within-subject placebo + placebo control condition.	Hydromorphone (Oral) 4mg + Placebo Condition n=29 Participants Within-subject hydromorphone 4mg + placebo control condition.	Hydromorphone (Oral) 4mg + Dronabinol (Oral) 2.5mg n=29 Participants Within-subject hydromorphone 4mg+ dronabinol 2.5mg experimental condition	Hydromorphone (Oral) 4mg + Dronabinol (Oral) 5.0mg n=29 Participants Within-subject hydromorphone 4mg+ dronabinol 5.0mg experimental condition	Hydromorphone (Oral) 4mg + Dronabinol (Oral) 10mg n=29 Participants Within-subject hydromorphone 4mg+ dronabinol 10mg experimental condition
Mean Change From Baseline in Seconds to Withdraw Hand From Cold Pressor Laboratory Pain Task	25.4 seconds Standard Error 12.7	33.9 seconds Standard Error 15.7	31.7 seconds Standard Error 10.9	36.7 seconds Standard Error 12.6	18.1 seconds Standard Error 5.4

PRIMARY outcome

Timeframe: 8-hour study session

Mean peak of Visual Analog Scale ratings of Drug Effect (0-100) compared across each study condition, with higher ratings reflecting stronger drug effects.

Outcome measures

Measure	Placebo + Placebo Condition n=29 Participants Within-subject placebo + placebo control condition.	Hydromorphone (Oral) 4mg + Placebo Condition n=29 Participants Within-subject hydromorphone 4mg + placebo control condition.	Hydromorphone (Oral) 4mg + Dronabinol (Oral) 2.5mg n=29 Participants Within-subject hydromorphone 4mg+ dronabinol 2.5mg experimental condition	Hydromorphone (Oral) 4mg + Dronabinol (Oral) 5.0mg n=29 Participants Within-subject hydromorphone 4mg+ dronabinol 5.0mg experimental condition	Hydromorphone (Oral) 4mg + Dronabinol (Oral) 10mg n=29 Participants Within-subject hydromorphone 4mg+ dronabinol 10mg experimental condition
Mean Peak Rating of "Drug Effect" (0-100) as Measured by the Visual Analog Rating Scale	10.0 score on a scale Standard Deviation 10.1	51.1 score on a scale Standard Deviation 22.9	55.7 score on a scale Standard Deviation 29.4	55.7 score on a scale Standard Deviation 29.3	56.9 score on a scale Standard Deviation 31.7

PRIMARY outcome

Timeframe: Baseline and 8-hours

Within-subject comparison of study conditions on the Digit Symbol Substitution Test (DSST), a measure of cognitive performance that is sensitive to drug effects, wherein lower percent scores reflect worse performance and suggest greater drug-related impairment.

Outcome measures

Measure	Placebo + Placebo Condition n=29 Participants Within-subject placebo + placebo control condition.	Hydromorphone (Oral) 4mg + Placebo Condition n=29 Participants Within-subject hydromorphone 4mg + placebo control condition.	Hydromorphone (Oral) 4mg + Dronabinol (Oral) 2.5mg n=29 Participants Within-subject hydromorphone 4mg+ dronabinol 2.5mg experimental condition	Hydromorphone (Oral) 4mg + Dronabinol (Oral) 5.0mg n=29 Participants Within-subject hydromorphone 4mg+ dronabinol 5.0mg experimental condition	Hydromorphone (Oral) 4mg + Dronabinol (Oral) 10mg n=29 Participants Within-subject hydromorphone 4mg+ dronabinol 10mg experimental condition
Mean Change From Baseline in Maximum Percent Correct on Digit Symbol Substitution Test of Cognitive Behavior	10.2 Mean Percent Correct Interval 0.0 to 100.0	5.1 Mean Percent Correct Interval 0.0 to 100.0	10.1 Mean Percent Correct Interval 0.0 to 100.0	10.3 Mean Percent Correct Interval 0.0 to 100.0	3.6 Mean Percent Correct Interval 0.0 to 100.0

Adverse Events

Placebo + Placebo Condition

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Hydromorphone (Oral) 4mg + Placebo Condition

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Hydromorphone (Oral) 4mg + Dronabinol (Oral) 2.5mg

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Hydromorphone (Oral) 4mg + Dronabinol (Oral) 5.0mg

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Hydromorphone (Oral) 4mg + Dronabinol (Oral) 10mg

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo + Placebo Condition n=29 participants at risk Within-subject placebo + placebo control condition.	Hydromorphone (Oral) 4mg + Placebo Condition n=29 participants at risk Within-subject hydromorphone 4mg + placebo control condition.	Hydromorphone (Oral) 4mg + Dronabinol (Oral) 2.5mg n=29 participants at risk Within-subject hydromorphone 4mg+ dronabinol 2.5mg experimental condition	Hydromorphone (Oral) 4mg + Dronabinol (Oral) 5.0mg n=29 participants at risk Within-subject hydromorphone 4mg+ dronabinol 5.0mg experimental condition	Hydromorphone (Oral) 4mg + Dronabinol (Oral) 10mg n=29 participants at risk Within-subject hydromorphone 4mg+ dronabinol 10mg experimental condition
Blood and lymphatic system disorders Headache	6.9% 2/29 • Number of events 2 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	6.9% 2/29 • Number of events 2 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	10.3% 3/29 • Number of events 3 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Blood and lymphatic system disorders Malaise	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Cardiac disorders Angina	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Cardiac disorders Tachycardia	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	6.9% 2/29 • Number of events 2 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	6.9% 2/29 • Number of events 2 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Gastrointestinal disorders Appetite- Increased	10.3% 3/29 • Number of events 3 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	10.3% 3/29 • Number of events 3 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	6.9% 2/29 • Number of events 2 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	20.7% 6/29 • Number of events 6 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	10.3% 3/29 • Number of events 3 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Gastrointestinal disorders Dry Mouth	6.9% 2/29 • Number of events 2 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	6.9% 2/29 • Number of events 2 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	10.3% 3/29 • Number of events 3 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	31.0% 9/29 • Number of events 9 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	31.0% 9/29 • Number of events 9 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Gastrointestinal disorders Epigastric Discomfort	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	10.3% 3/29 • Number of events 3 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Gastrointestinal disorders Nausea	6.9% 2/29 • Number of events 2 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	27.6% 8/29 • Number of events 8 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	24.1% 7/29 • Number of events 7 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	27.6% 8/29 • Number of events 8 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	37.9% 11/29 • Number of events 11 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Gastrointestinal disorders Vomiting	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	24.1% 7/29 • Number of events 7 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	27.6% 8/29 • Number of events 8 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	6.9% 2/29 • Number of events 2 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Blood and lymphatic system disorders Light Headedness	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Nervous system disorders Agitation	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Nervous system disorders Delerium	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Nervous system disorders Depression	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	10.3% 3/29 • Number of events 3 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Nervous system disorders Dizziness	6.9% 2/29 • Number of events 2 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	10.3% 3/29 • Number of events 3 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	10.3% 3/29 • Number of events 3 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	17.2% 5/29 • Number of events 5 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	6.9% 2/29 • Number of events 2 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Nervous system disorders Fatigue	6.9% 2/29 • Number of events 2 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	6.9% 2/29 • Number of events 2 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Nervous system disorders Hypersomnia	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Nervous system disorders Impaired- Groggy	17.2% 5/29 • Number of events 5 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	10.3% 3/29 • Number of events 3 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	10.3% 3/29 • Number of events 3 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	27.6% 8/29 • Number of events 8 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	27.6% 8/29 • Number of events 8 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Nervous system disorders Lethargy	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	10.3% 3/29 • Number of events 3 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	6.9% 2/29 • Number of events 2 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	6.9% 2/29 • Number of events 2 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	6.9% 2/29 • Number of events 2 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Nervous system disorders Light Headed	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	10.3% 3/29 • Number of events 3 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Nervous system disorders Nervousness	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Nervous system disorders Paranoid	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	10.3% 3/29 • Number of events 3 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Nervous system disorders Parasthesia	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Nervous system disorders Restlessness	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Nervous system disorders Shaky	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	6.9% 2/29 • Number of events 2 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Respiratory, thoracic and mediastinal disorders Rhinitis	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Eye disorders Photosensitivity	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Eye disorders Blurred Vision	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	10.3% 3/29 • Number of events 3 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Endocrine disorders Hot Flashes	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	6.9% 2/29 • Number of events 2 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Eye disorders Lacrimation	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Psychiatric disorders Panic Attack	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	3.4% 1/29 • Number of events 1 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Nervous system disorders Drowsiness	41.4% 12/29 • Number of events 12 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	75.9% 22/29 • Number of events 22 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	37.9% 11/29 • Number of events 11 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	86.2% 25/29 • Number of events 25 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	72.4% 21/29 • Number of events 21 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
Nervous system disorders Euphoria	0.00% 0/29 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	31.0% 9/29 • Number of events 9 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	37.9% 11/29 • Number of events 11 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	62.1% 18/29 • Number of events 18 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).	44.8% 13/29 • Number of events 13 • Adverse events were documented throughout each of the 5 outpatient, 8-hour sessions, up to 40 hours. Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).

Additional Information

Dr. Kelly Dunn

Johns Hopkins University School of Medicine

Phone: 410-550-2254

Email: kdunn9@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place