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Completed

NCT Number: NCT01685073

The Role of Sleep in the Treatment of Cannabis Use Disorders

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.

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Key information

Conditions

Drug Addiction Chemically-Induced Disorders Disease Attributes Dyssomnias Marijuana Abuse Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zolpidem extended-release

Drug

nightly administration of zolpidem extended-release

Other names: Ambien CR

MET/CBT

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2012
Registry last updated
May 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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