Trial · NCT01685073

The Role of Sleep in the Treatment of Cannabis Use Disorders

NCT01685073, Phase 2, Phase 3, Completed, Johns Hopkins University; results first posted 2019-05-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Role of Sleep in the Treatment of Cannabis Use Disorders. Trials, record NCT01685073. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01685073

On this page

Trial

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

Title: The Role of Sleep in the Treatment of Cannabis Use Disorders
NCT number: NCT01685073
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 127 participants, actual
Lead sponsor: Johns Hopkins University
Conditions: Drug Addiction
Interventions: Zolpidem extended-release, MET/CBT
First posted: 2012-09-13
Last updated: 2019-05-22
Results first posted: 2019-05-22
Limitations and caveats: There was a significant number of participant drop-outs in both study arms

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed	Week 1 of treatment	Percentage of time asleep while in bed is measured using ambulatory polysomnography (PSG) equipment.
Primary	Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing	Week 12	Qualitative urine cannabis testing outcomes of study participants; missing drop-outs presumed positive; Negative = THCCOOH \<50ng/mL via EIA.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed	Week 1 of treatment	Sleep data was not obtained for 12 people in the zolpidem group and 14 people in the placebo group at Week 1, and could not be included in this analysis. These individuals dropped out of the study or were lost to follow-up by the time of data collection.	percentage of time asleep while in bed	MEAN
PRIMARY	Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing	Week 12		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Category	Value	Spread	Units
Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed	Zolpidem		78	Standard Deviation 16	percentage of time asleep while in bed
Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed	Placebo		74	Standard Deviation 19	percentage of time asleep while in bed
Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing	Zolpidem	Negative urine test	17		Participants
Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing	Placebo	Negative urine test	10		Participants
Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing	Zolpidem	Positive urine test	45		Participants
Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing	Placebo	Positive urine test	55		Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Zolpidem	62
Overall Study	STARTED	Placebo	65
Overall Study	COMPLETED	Zolpidem	32
Overall Study	COMPLETED	Placebo	33
Overall Study	NOT COMPLETED	Zolpidem	30
Overall Study	NOT COMPLETED	Placebo	32

Source ClinicalTrials.gov

Adverse events16

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	Events
other	toothache	General disorders	Zolpidem	5	62	5
other	toothache	General disorders	Placebo	3	65	3
other	Headache	General disorders	Zolpidem	4	62	4
other	Headache	General disorders	Placebo	5	65	5
other	Cold symptoms	General disorders	Zolpidem	6	62	6
other	Cold symptoms	General disorders	Placebo	9	65	9
other	nausea	Gastrointestinal disorders	Zolpidem	7	62	7
other	nausea	Gastrointestinal disorders	Placebo	7	65	7
other	emesis	Gastrointestinal disorders	Zolpidem	6	62	6
other	emesis	Gastrointestinal disorders	Placebo	6	65	6

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Zolpidem	0	62
Total, all-cause mortality	Placebo	0	65
Total, other adverse events	Zolpidem	30	62
Total, other adverse events	Placebo	35	65
Total, serious adverse events	Zolpidem	2	62
Total, serious adverse events	Placebo	0	65

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28782982	DERIVED

Source PubMed

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
U01DA031784	Role of Sleep in the Treatment of Cannabis Dependence	VANDREY, RYAN G	JOHNS HOPKINS UNIVERSITY	NATIONAL INSTITUTE ON DRUG ABUSE	2012 to 2016

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
Zolpidem vs Placebo: deaths from any cause	Trial comparisons
Zolpidem vs Placebo: serious adverse events	Trial comparisons

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/NCT01685073

GET https://conductscience.org/api/trials/v1/NCT01685073/registered

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