Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis
CannSleep
2 other identifiers
interventional
57
1 country
2
Brief Summary
As medical cannabis use becomes more common in the United States, it is essential to understand the ways in which adults who use medical cannabis perceive the benefits of cannabis use and to identify effective strategies to help them cope with these problems. Emerging data indicate that insomnia and/or use of cannabis for sleep are very common in medical cannabis patients. The present study will adapt and gather pilot data on the impact of a Cognitive Behavioral Therapy for insomnia (CBTi-CB) intervention on sleep- and cannabis-related outcomes in adults who use medical cannabis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2019
CompletedFirst Posted
Study publicly available on registry
May 28, 2019
CompletedStudy Start
First participant enrolled
February 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 13, 2021
CompletedResults Posted
Study results publicly available
September 14, 2022
CompletedSeptember 14, 2022
August 1, 2022
1.4 years
May 17, 2019
July 7, 2022
August 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline Insomnia Severity Index Score at Study Completion
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
Study Arms (2)
Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB)
EXPERIMENTALSleep Hygiene Education (SHE)
PLACEBO COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (2)
Bloom City Club
Ann Arbor, Michigan, 48103, United States
Om of Medicine
Ann Arbor, Michigan, 48104, United States
Related Publications (5)
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.
PMID: 21377144BACKGROUNDIlgen 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.
PMID: 23683791BACKGROUNDAshrafioun 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.
PMID: 25481452BACKGROUNDCranford 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.
PMID: 28926791BACKGROUNDArnedt 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.
PMID: 23450712BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark Ilgen
- Organization
- University of Michigan
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry
Study Record Dates
First Submitted
May 17, 2019
First Posted
May 28, 2019
Study Start
February 10, 2020
Primary Completion
July 13, 2021
Study Completion
July 13, 2021
Last Updated
September 14, 2022
Results First Posted
September 14, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share