The Role of Sleep in the Treatment of Cannabis Use Disorders

May 21, 2019 updated by: Johns Hopkins University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Zolpidem
Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder
Drug: Zolpidem extended-release
nightly administration of zolpidem extended-release
Other Names:
  • Ambien CR
Behavioral: MET/CBT
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
PLACEBO_COMPARATOR: Placebo
Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder
Behavioral: MET/CBT
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 1 of treatment
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.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

July 1, 2018

Study Completion (ACTUAL)

July 1, 2018

Study Registration Dates

First Submitted

September 11, 2012

First Submitted That Met QC Criteria

September 12, 2012

First Posted (ESTIMATE)

September 13, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 22, 2019

Last Update Submitted That Met QC Criteria

May 21, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00068969
  • U01DA031784 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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