search
Back to results

The Role of Sleep in the Treatment of Cannabis Use Disorders

Primary Purpose

Drug Addiction

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zolpidem extended-release
MET/CBT
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Addiction focused on measuring marijuana, cannabis, treatment, insomnia, relapse

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zolpidem

Placebo

Arm Description

Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder

Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 11, 2012
Last Updated
May 21, 2019
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT01685073
Brief Title
The Role of Sleep in the Treatment of Cannabis Use Disorders
Official Title
The Role of Sleep in the Treatment of Cannabis Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Addiction
Keywords
marijuana, cannabis, treatment, insomnia, relapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zolpidem
Arm Type
Experimental
Arm Description
Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder
Intervention Type
Drug
Intervention Name(s)
Zolpidem extended-release
Other Intervention Name(s)
Ambien CR
Intervention Description
nightly administration of zolpidem extended-release
Intervention Type
Behavioral
Intervention Name(s)
MET/CBT
Intervention Description
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
Primary Outcome Measure Information:
Title
Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed
Description
Percentage of time asleep while in bed is measured using ambulatory polysomnography (PSG) equipment.
Time Frame
Week 1 of treatment
Title
Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing
Description
Qualitative urine cannabis testing outcomes of study participants; missing drop-outs presumed positive; Negative = THCCOOH <50ng/mL via EIA.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-55 years. Recent problematic use of cannabis Cannabis use impacts sleep Exclusion Criteria: Dependent on drugs other than cannabis or nicotine, or current Axis I psychiatric disorder Moderate sleep apnea or periodic limb movement disorder Pregnant, breast feeding, or planning to become pregnant within the next 3 months Current condition associated with severe cognitive/social impairment Allergy to any ingredient in extended-release zolpidem or prior adverse reaction to zolpidem Current use of drugs that affect metabolism via cytochrome P450 or current illness resulting in severe hepatic impairment Current use of hypnotic medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Vandrey, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28782982
Citation
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.
Results Reference
derived

Learn more about this trial

The Role of Sleep in the Treatment of Cannabis Use Disorders

We'll reach out to this number within 24 hrs