The Role of Sleep in the Treatment of Cannabis Use Disorders

Drug Addiction Clinical Trial

Official title:

The Role of Sleep in the Treatment of Cannabis Use Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685073
• Other study ID #: NA_00068969
• Secondary ID: U01DA031784
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2012
• Est. completion date: July 2018

Study information

• Verified date: May 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Addiction
• Marijuana Abuse
• Substance-Related Disorders

Intervention

Drug:
• Zolpidem extended-release
nightly administration of zolpidem extended-release

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

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed	Percentage of time asleep while in bed is measured using ambulatory polysomnography (PSG) equipment.	Week 1 of treatment
Primary	Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing	Qualitative urine cannabis testing outcomes of study participants; missing drop-outs presumed positive; Negative = THCCOOH <50ng/mL via EIA.	Week 12