The Role of Sleep in the Treatment of Cannabis Use Disorders
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ClinicalTrials.gov Identifier: NCT01685073 |
Recruitment Status :
Completed
First Posted : September 13, 2012
Results First Posted : May 22, 2019
Last Update Posted : May 22, 2019
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Sponsor:
Johns Hopkins University
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University
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Tracking Information | ||||
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First Submitted Date ICMJE | September 11, 2012 | |||
First Posted Date ICMJE | September 13, 2012 | |||
Results First Submitted Date ICMJE | May 1, 2019 | |||
Results First Posted Date ICMJE | May 22, 2019 | |||
Last Update Posted Date | May 22, 2019 | |||
Study Start Date ICMJE | September 2012 | |||
Actual Primary Completion Date | July 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | The Role of Sleep in the Treatment of Cannabis Use Disorders | |||
Official Title ICMJE | The Role of Sleep in the Treatment of Cannabis Use Disorders | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Drug Addiction | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
127 | |||
Original Estimated Enrollment ICMJE |
100 | |||
Actual Study Completion Date ICMJE | July 2018 | |||
Actual Primary Completion Date | July 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01685073 | |||
Other Study ID Numbers ICMJE | NA_00068969 U01DA031784 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | Johns Hopkins University | |||
Study Sponsor ICMJE | Johns Hopkins University | |||
Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | |||
Investigators ICMJE |
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PRS Account | Johns Hopkins University | |||
Verification Date | May 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |