The Role of Sleep in the Treatment of Cannabis Use Disorders

Phase 2

Completed

• Conditions: Drug Addiction
• Interventions: Drug: Zolpidem extended-release; Behavioral: MET/CBT

• Registration Number: NCT01685073
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-13
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2019-05
• Results First Submitted: 2019-05-01
• Results First Submitted QC: 2019-05-21
• Last Update Submitted: 2019-05-21
• Results First Posted: 2019-05-22
• Last Update Posted: 2019-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

1. Age 18-55 years.
2. Recent problematic use of cannabis
3. Cannabis use impacts sleep

Exclusion Criteria

1. Dependent on drugs other than cannabis or nicotine, or current Axis I psychiatric disorder
2. Moderate sleep apnea or periodic limb movement disorder
3. Pregnant, breast feeding, or planning to become pregnant within the next 3 months
4. Current condition associated with severe cognitive/social impairment
5. Allergy to any ingredient in extended-release zolpidem or prior adverse reaction to zolpidem
6. Current use of drugs that affect metabolism via cytochrome P450 or current illness resulting in severe hepatic impairment
7. Current use of hypnotic medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zolpidem	Zolpidem extended-release	Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder
Zolpidem	MET/CBT	Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder
Placebo	MET/CBT	Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States