Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis (CannSleep)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03964974|
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : April 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Insomnia Chronic Cannabis Use||Behavioral: Cognitive Behavioral Therapy for Insomnia in Cannabis Users Behavioral: Sleep Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis|
|Actual Study Start Date :||February 10, 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Cognitive Behavioral Therapy for Insomnia in Cannabis Users
Behavioral: Cognitive Behavioral Therapy for Insomnia in Cannabis Users
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 Name: Cognitive Behavioral Therapy
Placebo Comparator: Sleep Education
Psycho-education on sleep and sleep hygiene
Behavioral: Sleep Education
The SE 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.
- Change from baseline Insomnia Severity Index score at study completion [ Time Frame: 12 Weeks ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964974
|Contact: Mark A Ilgen, PhDemail@example.com|
|Contact: John T Arnedt, PhDfirstname.lastname@example.org|
|United States, Michigan|
|Bloom City Club||Recruiting|
|Ann Arbor, Michigan, United States, 48103|
|Contact: Julie Barron, MSW|
|Om of Medicine||Recruiting|
|Ann Arbor, Michigan, United States, 48104|
|Contact: Evan Litinas, MD|