The Role of Sleep in the Treatment of Cannabis Use Disorders
NCT ID: NCT01685073
Last Updated: 2019-05-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
127 participants
INTERVENTIONAL
2012-09-30
2018-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Zolpidem
Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder
Zolpidem extended-release
nightly administration of zolpidem extended-release
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
Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder
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
Interventions
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Zolpidem extended-release
nightly administration of zolpidem extended-release
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Recent problematic use of cannabis
3. Cannabis use impacts sleep
Exclusion Criteria
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
18 Years
55 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Ryan Vandrey, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NA_00068969
Identifier Type: -
Identifier Source: org_study_id
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