Phase 3
Completed N=127
The Role of Sleep in the Treatment of Cannabis Use Disorders
Source: ClinicalTrials.gov NCT01685073 ↗Enrolled (actual)
127
Serious AEs
1.6%
Results posted
May 2019
Primary outcomePrimary: Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed — 78; 74 percentage of time asleep while in bed
◆ Published Evidence
Established
40citations · ~4 / year
Sleep continuity, architecture and quality among treatment-seeking cannabis users: An in-home, unattended polysomnographic study.
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.
Linked Publications
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Sleep continuity, architecture and quality among treatment-seeking cannabis users: An in-home, unattended polysomnographic study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed |
78; 74 | — |
| PRIMARY Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing |
17; 10; 45; 55 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01685073) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.