The Role of Sleep in the Treatment of Cannabis Use Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ryan Vandrey, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01685073
First received: September 11, 2012
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Drug Addiction
Drug: Zolpidem extended-release
Behavioral: MET/CBT
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Role of Sleep in the Treatment of Cannabis Use Disorders

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Sleep Efficiency [ Time Frame: up to 24 Weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685073

Contacts
Contact: Eva Lenoir 410-550-1929 elenoir1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21224
Contact: Eva Lenoir    410-550-1929    elenoir1@jhmi.edu   
Principal Investigator: Ryan Vandrey, PhD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Ryan Vandrey, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Ryan Vandrey, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01685073     History of Changes
Other Study ID Numbers: NA_00068969
Study First Received: September 11, 2012
Last Updated: June 13, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Behavior, Addictive
Mental Disorders
Compulsive Behavior
Impulsive Behavior
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014