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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

90 participants

Primary outcome timeframe

4 nights

Results posted on

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

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

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 nights

Population: 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

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 taper

Population: 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

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 discontinuation

Population: 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

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 taper

Population: 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

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 discontinuation

Population: 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

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

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Low Dose Suvorexant

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

High Dose Suvorexant

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Pre-randomization

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Phone: 410-550-1971

Results disclosure agreements

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