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CannSleep: Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT03964974
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
57
Enrollment
2
Locations
2
Arms
17.1
Actual Duration (Months)
28.5
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Behavioral Therapy for Insomnia in Cannabis Users
  • Behavioral: Sleep Education
 N/A

Detailed Description

In recent years, the movement to promote the legalization of medical cannabis has grown in the United States and now 29 States and the District of Columbia have provisions that allow for the use of cannabis for medical reasons. Irrespective of the specific reasons for seeking medical cannabis, adults who have been evaluated for medical cannabis certification report significant sleep-related problems as well as frequent use of cannabis to address their sleep problems. Cannabis use for sleep is a key potential target for interventions given that prior research has found that, among individuals with cannabis use disorders, poor sleep is a barrier to sustained remission from cannabis use. Cognitive Behavioral Therapy (CBT) for insomnia is highly effective in individuals with insomnia comorbid with other health conditions, including substance use disorders; however, existing efficacy trials have not specifically evaluated its benefit in those who use cannabis for insomnia. The impact of CBT for insomnia on either sleep or cannabis use in medical cannabis users is, therefore, unknown. The objectives of this project are to adapt and tailor a telephone-delivered CBT for insomnia for adults who use medical cannabis (CBTi-CB) and to evaluate the acceptability and feasibility of this intervention. Qualitative and quantitative data will be collected to refine an existing CBTi-CB protocol and conduct a pilot test of the modified intervention in adults who use medical cannabis. Adults seeking certification for medical cannabis will be approached while waiting for their appointment and screened for insomnia as well as cannabis use for sleep. After initial qualitative interviews and beta testing, eligible participants (N = 60) will be randomized to CBTi-CB or Sleep Education Control (SE) condition, delivered over the telephone. Participants will provide self-report data on sleep/insomnia, functioning and cannabis use and objective data on sleep quality will be measured by actigraphy. The study will evaluate changes in self-reported and objectively measured sleep, functioning and frequency/quantity of cannabis use during treatment and over the course of 18-weeks post-baseline. Completion of the study aims will provide all of the elements required for a future fully-powered randomized trial of the longer-term efficacy of CBTi-CB among those with medical cannabis. This line of research would be the first to evaluate a highly effective sleep-focused intervention and determine the effects on sleep-related and non-sleep-related cannabis use in a non-treatment seeking population.

Study Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis
Actual Study Start Date :
Feb 10, 2020
Actual Primary Completion Date :
Jul 13, 2021
Actual Study Completion Date :
Jul 13, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: CBTi-CB

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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline Insomnia Severity Index score at study completion [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 THC,

    • Consistent access to a telephone, smartphone, 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bloom City Club Ann Arbor Michigan United States 48103
    2 Om of Medicine Ann Arbor Michigan United States 48104

    Sponsors and Collaborators

    • University of Michigan
    • National Institute on Drug Abuse (NIDA)

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Mark A. Ilgen, Associate Professor of Psychiatry, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT03964974
    Other Study ID Numbers:
    • HUM00151282
    • 1R34DA047466-01
    First Posted:
    May 28, 2019
    Last Update Posted:
    Apr 29, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Marijuana Abuse

    Study Results

    No Results Posted as of Apr 29, 2022