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The Role of Sleep in the Treatment of Cannabis Use Disorders

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ClinicalTrials.gov Identifier: NCT01685073
Recruitment Status : Active, not recruiting
First Posted : September 13, 2012
Last Update Posted : December 18, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Drug Addiction Drug: Zolpidem extended-release Behavioral: MET/CBT Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Role of Sleep in the Treatment of Cannabis Use Disorders
Study Start Date : September 2012
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
U.S. FDA Resources

Arms and Interventions

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 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
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


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685073


Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Ryan Vandrey, PhD Johns Hopkins University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01685073     History of Changes
Other Study ID Numbers: NA_00068969
U01DA031784 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2012    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Johns Hopkins University:
marijuana
cannabis
treatment
insomnia
relapse

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action