Trial · NCT03789214

Medical Management of Sleep Disturbance During Opioid Tapering

NCT03789214, Phase 2, Completed, Johns Hopkins University; results first posted 2022-08-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Medical Management of Sleep Disturbance During Opioid Tapering. Trials, record NCT03789214. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03789214

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Medical Management of Sleep Disturbance During Opioid Tapering
NCT number: NCT03789214
Status: Completed
Phases: Phase 2
Enrollment: 90 participants, actual
Lead sponsor: Johns Hopkins University
Conditions: Opioid Dependence, Opioid Withdrawal, Sleep Disturbance
Interventions: Placebo oral capsule, Low Dose Suvorexant, High Dose Suvorexant
First posted: 2018-12-28
Last updated: 2022-08-08
Results first posted: 2022-08-08

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Abuse Liability as Assessed by Visual Analogue Scale	4 nights	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.
Primary	Total Sleep Time During Buprenorphine Taper	Four nights during a buprenorphine taper	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.
Primary	Total Sleep Time During Post-taper	Four nights following buprenorphine discontinuation	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.
Primary	Subjective Opiate Withdrawal Scale During Buprenorphine Taper	Three days during a buprenorphine taper	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).
Primary	Subjective Opiate Withdrawal Scale During Post-taper	Three days following buprenorphine discontinuation	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).

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Abuse Liability as Assessed by Visual Analogue Scale	4 nights	Participants who completed the buprenorphine taper. 1 participant dropped out of the high dose suvorexant condition.	score on a scale*days	MEAN
PRIMARY	Total Sleep Time During Buprenorphine Taper	Four nights during a buprenorphine taper	Participants who completed the buprenorphine taper. 1 participant dropped out of the high dose suvorexant condition.	minutes*nights	MEAN
PRIMARY	Total Sleep Time During Post-taper	Four nights following buprenorphine discontinuation	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.	minutes*nights	MEAN
PRIMARY	Subjective Opiate Withdrawal Scale During Buprenorphine Taper	Three days during a buprenorphine taper	Participants who completed the buprenorphine taper. 1 participant dropped out of the high dose suvorexant condition.	score on a scale*days	MEAN
PRIMARY	Subjective Opiate Withdrawal Scale During Post-taper	Three days following buprenorphine discontinuation	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.	score on a scale*days	MEAN

Source ClinicalTrials.gov

Results by group15

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Abuse Liability as Assessed by Visual Analogue Scale	Placebo	23.9	Standard Deviation 33.5	score on a scale*days
Abuse Liability as Assessed by Visual Analogue Scale	Low Dose Suvorexant	20.9	Standard Deviation 28.7	score on a scale*days
Abuse Liability as Assessed by Visual Analogue Scale	High Dose Suvorexant	22.8	Standard Deviation 31.0	score on a scale*days
Total Sleep Time During Buprenorphine Taper	Placebo	891.6	Standard Deviation 287.9	minutes*nights
Total Sleep Time During Buprenorphine Taper	Low Dose Suvorexant	1183.6	Standard Deviation 300.1	minutes*nights
Total Sleep Time During Buprenorphine Taper	High Dose Suvorexant	1098.4	Standard Deviation 287.3	minutes*nights
Total Sleep Time During Post-taper	Placebo	1049.3	Standard Deviation 253.6	minutes*nights
Total Sleep Time During Post-taper	Low Dose Suvorexant	1113.2	Standard Deviation 342.1	minutes*nights
Total Sleep Time During Post-taper	High Dose Suvorexant	1055.9	Standard Deviation 274.5	minutes*nights
Subjective Opiate Withdrawal Scale During Buprenorphine Taper	Placebo	15.5	Standard Deviation 12.0	score on a scale*days

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	12
Overall Study	STARTED	Low Dose Suvorexant	14
Overall Study	STARTED	High Dose Suvorexant	12
Overall Study	COMPLETED	Placebo	8
Overall Study	COMPLETED	Low Dose Suvorexant	9
Overall Study	COMPLETED	High Dose Suvorexant	9
Overall Study	NOT COMPLETED	Placebo	4
Overall Study	NOT COMPLETED	Low Dose Suvorexant	5
Overall Study	NOT COMPLETED	High Dose Suvorexant	3

Source ClinicalTrials.gov

Adverse events144

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headache	General disorders	Placebo	6	12
other	Headache	General disorders	Low Dose Suvorexant	3	14
other	Headache	General disorders	High Dose Suvorexant	2	12
other	Headache	General disorders	Pre-randomization	5	38
other	Abdominal Cramp	Gastrointestinal disorders	Placebo	1	12
other	Abdominal Cramp	Gastrointestinal disorders	Low Dose Suvorexant	0	14
other	Abdominal Cramp	Gastrointestinal disorders	High Dose Suvorexant	0	12
other	Abdominal Cramp	Gastrointestinal disorders	Pre-randomization	3	38
other	Abdominal Distention	Gastrointestinal disorders	Placebo	3	12
other	Abdominal Distention	Gastrointestinal disorders	Low Dose Suvorexant	0	14

1 to 10 of 144Source ClinicalTrials.gov

See all 144 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	12
Total, all-cause mortality	Low Dose Suvorexant	0	14
Total, all-cause mortality	High Dose Suvorexant	0	12
Total, all-cause mortality	Pre-randomization	0	38
Total, other adverse events	Placebo	6	12
Total, other adverse events	Low Dose Suvorexant	8	14
Total, other adverse events	High Dose Suvorexant	7	12
Total, other adverse events	Pre-randomization	10	38
Total, serious adverse events	Placebo	0	12
Total, serious adverse events	Low Dose Suvorexant	0	14

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
UG3DA048734	Evaluating Suvorexant for Sleep Disturbance in Opioid Use Disorder	HUHN, ANDREW S; DUNN, KELLY E	JOHNS HOPKINS UNIVERSITY	NATIONAL INSTITUTE ON DRUG ABUSE	2019 to 2020

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03789214

GET https://conductscience.org/api/trials/v1/NCT03789214/events?page=2

API reference For AI assistants