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The Role of Sleep in the Treatment of Cannabis Use Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01685073
Recruitment Status : Completed
First Posted : September 13, 2012
Results First Posted : May 22, 2019
Last Update Posted : May 22, 2019
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE September 11, 2012
First Posted Date  ICMJE September 13, 2012
Results First Submitted Date  ICMJE May 1, 2019
Results First Posted Date  ICMJE May 22, 2019
Last Update Posted Date May 22, 2019
Study Start Date  ICMJE September 2012
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2012)
  • Sleep Efficiency [ Time Frame: up to 24 Weeks ]
    Sleep will be objectively measured at 5 time points during the study assessment period using ambulatory polysomnography (PSG) equipment.
  • Cannabis Abstinence [ Time Frame: Twice weekly on Weeks 1-12; Week 24 and 36 ]
    Urine drug testing will determine whether study participants are abstinent from cannabis use throughout participation in treatment (12 weeks) and at 3- and 6-month follow-up assessments
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE The Role of Sleep in the Treatment of Cannabis Use Disorders
Official Title  ICMJE The Role of Sleep in the Treatment of Cannabis Use Disorders
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Drug Addiction
Intervention  ICMJE
  • Drug: Zolpidem extended-release
    nightly administration of zolpidem extended-release
    Other Name: 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
Study Arms  ICMJE
  • 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
    • Behavioral: MET/CBT
  • Placebo Comparator: Placebo
    Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder
    Intervention: Behavioral: MET/CBT
Publications * Pacek LR, Herrmann ES, Smith MT, Vandrey R. Sleep continuity, architecture and quality among treatment-seeking cannabis users: An in-home, unattended polysomnographic study. Exp Clin Psychopharmacol. 2017 Aug;25(4):295-302. doi: 10.1037/pha0000126.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2018)
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2012)
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01685073
Other Study ID Numbers  ICMJE NA_00068969
U01DA031784 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Ryan Vandrey, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP