- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03964974
Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis (CannSleep)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48103
- Bloom City Club
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Ann Arbor, Michigan, United States, 48104
- Om of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 21 years or older
- Insomnia Severity Index (ISI) score greater than 10 (indicating mild insomnia),
- Use of cannabis on average three times a week for the past three months,
- Self-reported use of cannabis to manage insomnia at least once a week over the past month,
- Positive drug screen for Tetrahydrocannabinol (THC),
- Consistent access to a telephone, smart phone, laptop, or tablet
Exclusion Criteria:
- Individuals who do not understand English,
- Individuals judged unable to provide informed consent (e.g. intoxication, mental incompetence),
- Diagnosis or high suspicion of a sleep disorder based on validated self-report questionnaires,
- Self-reported cancer,
- Self-reported pregnancy,
- Self-reported rotating or night (3rd) shift work.
- Participants taking medications for sleep will be included if they meet study criteria for insomnia, medications have been stable for at least 8 weeks, and they agree to maintain the same regimen throughout the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB)
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Each CBTi-CB therapy session will review the previous week of sleep/wake diaries and summarize key sleep parameters with participants.
The treatment will address cannabis use by increasing use of appropriate coping strategies and improving self-efficacy to manage insomnia and next-day consequences.
The content includes: (1) Sleep Scheduling Strategies to consolidate sleep using behavioral strategies that increase the drive for sleep and stabilize the circadian timing system; (2) Sleep Hygiene to discuss behaviors, substances, and environmental conditions that can help or hinder sleep; (3) Cognitive Therapy aims to identify and alter dysfunctional beliefs about sleep and functioning that contribute to insomnia; (4) Counter-Arousal Strategies address ruminative thoughts and increased body tension interfering with ability to fall or return to sleep; (5) Relapse Prevention for Insomnia reviews treatment gains and the behavioral and cognitive strategies that were most helpful.
Other Names:
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Placebo Comparator: Sleep Hygiene Education (SHE)
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The SHE condition will be matched to the CBTi-CB condition in terms of level of attention and the non-specific aspects of receiving social support from a study therapist, without providing individualized recommendations.
The current content includes: (1) Insomnia History of the participant, including triggers that initiated the problem, duration, severity, and frequency, premorbid sleep characteristics, and previous sleep treatments; (2) Sleep Education about why we sleep, sleep stages, sleep regulation at night, and sleep changes across lifespan; (3) Substance Use and Sleep and the effects of cannabis and other licit and illicit substances on sleep; (4) Environmental Factors that contribute to a sleep-conducive environment; (5) Lifestyle Factors like the effects of diet, exercise, and napping on sleep; (6) Sleep Maintenance Strategies to review treatment gains from the participant's perspective and emphasize the principles covered to maintain sleep improvements.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline Insomnia Severity Index Score at Study Completion
Time Frame: 16 Weeks
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The Insomnia Severity Index (ISI) is a brief self-report instrument measuring the patient's perception of both nocturnal and diurnal symptoms of insomnia. The ISI comprises seven items assessing the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. The range of the ISI is 0 to 28, with 28 corresponding to maximum severity. |
16 Weeks
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Arnedt JT, Conroy DA, Armitage R, Brower KJ. Cognitive-behavioral therapy for insomnia in alcohol dependent patients: a randomized controlled pilot trial. Behav Res Ther. 2011 Apr;49(4):227-33. doi: 10.1016/j.brat.2011.02.003. Epub 2011 Feb 15.
- Ilgen MA, Bohnert K, Kleinberg F, Jannausch M, Bohnert AS, Walton M, Blow FC. Characteristics of adults seeking medical marijuana certification. Drug Alcohol Depend. 2013 Oct 1;132(3):654-9. doi: 10.1016/j.drugalcdep.2013.04.019. Epub 2013 May 15.
- Ashrafioun L, Bohnert KM, Jannausch M, Ilgen MA. Characteristics of substance use disorder treatment patients using medical cannabis for pain. Addict Behav. 2015 Mar;42:185-8. doi: 10.1016/j.addbeh.2014.11.024. Epub 2014 Nov 26.
- Cranford JA, Arnedt JT, Conroy DA, Bohnert KM, Bourque C, Blow FC, Ilgen M. Prevalence and correlates of sleep-related problems in adults receiving medical cannabis for chronic pain. Drug Alcohol Depend. 2017 Nov 1;180:227-233. doi: 10.1016/j.drugalcdep.2017.08.017. Epub 2017 Sep 9.
- Arnedt JT, Cuddihy L, Swanson LM, Pickett S, Aikens J, Chervin RD. Randomized controlled trial of telephone-delivered cognitive behavioral therapy for chronic insomnia. Sleep. 2013 Mar 1;36(3):353-62. doi: 10.5665/sleep.2448.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00151282
- 1R34DA047466-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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