The Role of Sleep in the Treatment of Cannabis Use Disorders

Study Overview
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Brief Summary
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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.

Official Title
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The Role of Sleep in the Treatment of Cannabis Use Disorders

Conditions
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Drug Addiction

Intervention / Treatment
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* Drug: Zolpidem extended-release
* Behavioral: MET/CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-55 years. Recent problematic use of cannabis Cannabis use impacts sleep Exclusion Criteria: Dependent on drugs other than cannabis or nicotine, or current Axis I psychiatric disorder Moderate sleep apnea or periodic limb movement disorder Pregnant, breast feeding, or planning to become pregnant within the next 3 months Current condition associated with severe cognitive/social impairment Allergy to any ingredient in extended-release zolpidem or prior adverse reaction to zolpidem Current use of drugs that affect metabolism via cytochrome P450 or current illness resulting in severe hepatic impairment Current use of hypnotic medications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zolpidem<br>Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder | Drug: Zolpidem extended-release<br>* nightly administration of zolpidem extended-release<br>* Other names: Ambien CR;Behavioral: MET/CBT<br>* a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants<br>|
| Placebo Comparator: Placebo<br>Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder | Behavioral: MET/CBT<br>* a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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marijuana, cannabis, treatment, insomnia, relapse