NCT01685073 is a Phase 2/Phase 3 clinical trial of Zolpidem extended-release in Drug Addiction, sponsored by Johns Hopkins University.

Who is sponsoring NCT01685073?

NCT01685073 is sponsored by Johns Hopkins University.

What drugs are being tested in NCT01685073?

Interventions in NCT01685073: Zolpidem extended-release, MET/CBT.

What condition does NCT01685073 study?

NCT01685073 studies Drug Addiction.

Is NCT01685073 still recruiting?

NCT01685073 is currently completed. Last updated 21 May 2019.

Are results published for NCT01685073?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-05-21 · How we verify

NCT01685073

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Role of Sleep in the Treatment of Cannabis Use Disorders

Completed Phase 2/Phase 3 Results posted Last updated 21 May 2019

What this trial tests

Phase 2/Phase 3 trial testing Zolpidem extended-release in Drug Addiction in 127 participants. Completed in 1 July 2018.

Timeline

1 September 2012

Primary endpoint
1 July 2018

1 July 2018

Quick facts

Lead sponsor	Johns Hopkins University
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	127
Start date	1 September 2012
Primary completion	1 July 2018
Estimated completion	1 July 2018
Sites	1 location across United States

Drugs / interventions tested

Zolpidem extended-release
MET/CBT

Conditions studied

Drug Addiction — all drugs for Drug Addiction →

Sponsor

Johns Hopkins University

Who can join

Adults 18 to 55, any sex, with Drug Addiction. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

The number of people seeking treatment for marijuana-related problems is on the rise, yet there is no currently accepted medication proven to help them quit. Frequent marijuana users have reported that they have trouble sleeping when they try to quit, and that the loss of sleep can lead to relapse. This research is designed to measure the severity of sleep problems in people as they are trying to quit heavy use of marijuana, and to investigate whether extended-release zolpidem (Ambien CR®) can improve quit rates among people trying to stop using marijuana.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Sleep continuity, architecture and quality among treatment-seeking cannabis users: An in-home, unattended polysomnographic study.
Pacek LR, Herrmann ES, Smith MT, Vandrey R. · · 2017 · cited 25× · PMID 28782982 · DOI 10.1037/pha0000126
Randomized controlled trial of zolpidem as a pharmacotherapy for cannabis use disorder.
Lee DC, Schlienz NJ, Herrmann ES, Martin EL, et al · · 2024 · cited 3× · PMID 37802317 · DOI 10.1016/j.josat.2023.209180

Verify or expand the search:

Other recruiting trials for Drug Addiction

Currently open trials in the same condition.

NCT07033728 — The Health of Women Monitored in the Addiction Department of the Strasbourg University Hospitals · recruiting
NCT05534815 — Long-Term Treatment of Opioid Use Disorder · NA · recruiting
NCT03745339 — Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder · recruiting

Other Johns Hopkins University trials

Trials by the same sponsor.

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NCT07532252 — Daridorexant for Alcohol Use Disorder · Phase 2 · not yet recruiting
NCT06687655 — Impact of Exogenous Ketones on Sleep Apnea · Phase 1, PHASE2 · not yet recruiting
NCT07079111 — 3D Printed Occlusal Splints for Intraoperative Use · NA · not yet recruiting
NCT02998502 — The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01685073 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
Last refreshed: 21 May 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01685073.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing