Trial Outcomes & Findings for Medical Management of Sleep Disturbance During Opioid Tapering (NCT NCT03789214)
NCT ID: NCT03789214
Last Updated: 2022-08-08
Results Overview
Area-under-the-curve of self-reported feelings of drug "High" on the morning after study drug administration, measured each morning on a 0-100 point visual analogue scale of the question "Last night, did you feel HIGH?". A score of "0" indicates no abuse liability and a score of 100 indicates extreme abuse liability. This will be assessed over four nights during an opioid taper.
COMPLETED
PHASE2
90 participants
4 nights
2022-08-08
Participant Flow
90 individuals were consented and screened (35 did not meet eligibility criteria), 55 were scheduled for admission (7 did not present for admission), 48 were admitted for buprenorphine induction (2 were found to be ineligible at this stage and another 6 left prior to randomization), 40 were randomized (1 left before receiving study drug and 1 was excluded because of uncontrolled precipitated withdrawal), and 38 were included in the analyses of study outcomes.
Participant milestones
| Measure |
Placebo
Placebo sleep medication (Placebo oral capsule)
Placebo oral capsule: Placebo Sleep Medication
|
Low Dose Suvorexant
Low dose sleep medication
Low Dose Suvorexant: Low Dose Suvorexant
|
High Dose Suvorexant
High dose sleep medication
High Dose Suvorexant: High Dose Suvorexant
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
14
|
12
|
|
Overall Study
COMPLETED
|
8
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Medical Management of Sleep Disturbance During Opioid Tapering
Baseline characteristics by cohort
| Measure |
Placebo
n=12 Participants
Placebo sleep medication (Placebo oral capsule)
Placebo oral capsule: Placebo Sleep Medication
|
Low Dose Suvorexant
n=14 Participants
Low dose sleep medication
Low Dose Suvorexant: Low Dose Suvorexant
|
High Dose Suvorexant
n=12 Participants
High dose sleep medication
High Dose Suvorexant: High Dose Suvorexant
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.0 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
36.7 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
46.3 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 nightsPopulation: Participants who completed the buprenorphine taper. 1 participant dropped out of the high dose suvorexant condition.
Area-under-the-curve of self-reported feelings of drug "High" on the morning after study drug administration, measured each morning on a 0-100 point visual analogue scale of the question "Last night, did you feel HIGH?". A score of "0" indicates no abuse liability and a score of 100 indicates extreme abuse liability. This will be assessed over four nights during an opioid taper.
Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo sleep medication (Placebo oral capsule)
Placebo oral capsule: Placebo Sleep Medication
|
Low Dose Suvorexant
n=14 Participants
Low dose sleep medication
Low Dose Suvorexant: Low Dose Suvorexant
|
High Dose Suvorexant
n=11 Participants
High dose sleep medication
High Dose Suvorexant: High Dose Suvorexant
|
|---|---|---|---|
|
Abuse Liability as Assessed by Visual Analogue Scale
|
23.9 score on a scale*days
Standard Deviation 33.5
|
20.9 score on a scale*days
Standard Deviation 28.7
|
22.8 score on a scale*days
Standard Deviation 31.0
|
PRIMARY outcome
Timeframe: Four nights during a buprenorphine taperPopulation: Participants who completed the buprenorphine taper. 1 participant dropped out of the high dose suvorexant condition.
Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.
Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo sleep medication (Placebo oral capsule)
Placebo oral capsule: Placebo Sleep Medication
|
Low Dose Suvorexant
n=14 Participants
Low dose sleep medication
Low Dose Suvorexant: Low Dose Suvorexant
|
High Dose Suvorexant
n=11 Participants
High dose sleep medication
High Dose Suvorexant: High Dose Suvorexant
|
|---|---|---|---|
|
Total Sleep Time During Buprenorphine Taper
|
891.6 minutes*nights
Standard Deviation 287.9
|
1183.6 minutes*nights
Standard Deviation 300.1
|
1098.4 minutes*nights
Standard Deviation 287.3
|
PRIMARY outcome
Timeframe: Four nights following buprenorphine discontinuationPopulation: Prior to completion of the post-taper phase, 4 participants dropped out from the placebo condition, 5 dropped out from the low-dose suvorexant condition, and 3 dropped out from the high-dose suvorexant condition.
Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo sleep medication (Placebo oral capsule)
Placebo oral capsule: Placebo Sleep Medication
|
Low Dose Suvorexant
n=9 Participants
Low dose sleep medication
Low Dose Suvorexant: Low Dose Suvorexant
|
High Dose Suvorexant
n=9 Participants
High dose sleep medication
High Dose Suvorexant: High Dose Suvorexant
|
|---|---|---|---|
|
Total Sleep Time During Post-taper
|
1049.3 minutes*nights
Standard Deviation 253.6
|
1113.2 minutes*nights
Standard Deviation 342.1
|
1055.9 minutes*nights
Standard Deviation 274.5
|
PRIMARY outcome
Timeframe: Three days during a buprenorphine taperPopulation: Participants who completed the buprenorphine taper. 1 participant dropped out of the high dose suvorexant condition.
Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).
Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo sleep medication (Placebo oral capsule)
Placebo oral capsule: Placebo Sleep Medication
|
Low Dose Suvorexant
n=14 Participants
Low dose sleep medication
Low Dose Suvorexant: Low Dose Suvorexant
|
High Dose Suvorexant
n=11 Participants
High dose sleep medication
High Dose Suvorexant: High Dose Suvorexant
|
|---|---|---|---|
|
Subjective Opiate Withdrawal Scale During Buprenorphine Taper
|
15.5 score on a scale*days
Standard Deviation 12.0
|
10.8 score on a scale*days
Standard Deviation 15.1
|
14.8 score on a scale*days
Standard Deviation 11.2
|
PRIMARY outcome
Timeframe: Three days following buprenorphine discontinuationPopulation: Prior to completion of the post-taper phase, 4 participants dropped out from the placebo condition, 5 dropped out from the low-dose suvorexant condition, and 3 dropped out from the high-dose suvorexant condition.
Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo sleep medication (Placebo oral capsule)
Placebo oral capsule: Placebo Sleep Medication
|
Low Dose Suvorexant
n=9 Participants
Low dose sleep medication
Low Dose Suvorexant: Low Dose Suvorexant
|
High Dose Suvorexant
n=9 Participants
High dose sleep medication
High Dose Suvorexant: High Dose Suvorexant
|
|---|---|---|---|
|
Subjective Opiate Withdrawal Scale During Post-taper
|
17.9 score on a scale*days
Standard Deviation 15.1
|
9.0 score on a scale*days
Standard Deviation 9.8
|
6.4 score on a scale*days
Standard Deviation 3.9
|
Adverse Events
Placebo
Low Dose Suvorexant
High Dose Suvorexant
Pre-randomization
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=12 participants at risk
Placebo sleep medication (Placebo oral capsule)
Placebo oral capsule: Placebo Sleep Medication
|
Low Dose Suvorexant
n=14 participants at risk
Low dose sleep medication
Low Dose Suvorexant: Low Dose Suvorexant
|
High Dose Suvorexant
n=12 participants at risk
High dose sleep medication
High Dose Suvorexant: High Dose Suvorexant
|
Pre-randomization
n=38 participants at risk
Pre-randomization to Suvorexant or placebo groups
|
|---|---|---|---|---|
|
General disorders
Headache
|
50.0%
6/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
21.4%
3/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
16.7%
2/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
13.2%
5/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Gastrointestinal disorders
Abdominal Cramp
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
7.9%
3/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Gastrointestinal disorders
Abdominal Distention
|
25.0%
3/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
10.5%
4/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
14.3%
2/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
5.3%
2/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Gastrointestinal disorders
Indigestion
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
10.5%
4/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Reproductive system and breast disorders
Prolonged Erection
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
7.1%
1/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Psychiatric disorders
Agitation
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
2.6%
1/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Nervous system disorders
Confusion
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
14.3%
2/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Nervous system disorders
Dream Abnormal
|
33.3%
4/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
14.3%
2/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
25.0%
3/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Nervous system disorders
Drowsiness
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
7.1%
1/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
16.7%
2/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
2.6%
1/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Nervous system disorders
Euphoria
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
14.3%
2/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Nervous system disorders
Impaired/Groggy
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
14.3%
2/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
2.6%
1/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
2.6%
1/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
General disorders
Appetite Decreased
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
2.6%
1/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
General disorders
Appetite Increased
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
2.6%
1/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
5.3%
2/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Gastrointestinal disorders
Dyspensia
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
2.6%
1/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Gastrointestinal disorders
Flatulance
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
5.3%
2/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
10.5%
4/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
2.6%
1/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Musculoskeletal and connective tissue disorders
Pain Lower Extremity
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
2.6%
1/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Nervous system disorders
Insomnia
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Psychiatric disorders
Irritability
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Nervous system disorders
Light headed
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
5.3%
2/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Nervous system disorders
Tremor
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Nervous system disorders
Stuttering/Fluency Disorder
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
2.6%
1/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Eye disorders
Photophobia
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
14.3%
2/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Skin and subcutaneous tissue disorders
Sweat Increased
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Eye disorders
Blurred Vision
|
8.3%
1/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Skin and subcutaneous tissue disorders
Itchy Eyes
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
2.6%
1/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
|
Eye disorders
Eye Pain
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/14 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
0.00%
0/12 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
2.6%
1/38 • 11 days of residential treatment and 5-10 days of follow-up (16-21 days total).
Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.
|
Additional Information
Andrew S. Huhn, Ph.D.
The Johns Hopkins University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place