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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
First received
Last updated
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
Health authority
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

Study Design


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
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