Phase 3 N=127 Randomized Double-blind Treatment

The Role of Sleep in the Treatment of Cannabis Use Disorders

Drug Addiction

Bottom Line

View on ClinicalTrials.gov: NCT01685073 ↗

Enrolled (actual)

127

Serious AEs

1.6%

Results posted

May 2019

Primary outcome: Primary: Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed — 78; 74 percentage of time asleep while in bed

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Zolpidem extended-release (Drug); MET/CBT (Behavioral)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Jul 2018

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01685073). 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.