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Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis (CannSleep)

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ClinicalTrials.gov Identifier: NCT03964974
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : April 21, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mark A. Ilgen, University of Michigan

Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE May 28, 2019
Last Update Posted Date April 21, 2020
Actual Study Start Date  ICMJE February 10, 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
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 Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis
Official Title  ICMJE Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Insomnia Chronic
  • Cannabis Use
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: CBTi-CB
    Cognitive Behavioral Therapy for Insomnia in Cannabis Users
    Intervention: Behavioral: Cognitive Behavioral Therapy for Insomnia in Cannabis Users
  • Placebo Comparator: Sleep Education
    Psycho-education on sleep and sleep hygiene
    Intervention: Behavioral: Sleep Education
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mark A Ilgen, PhD 734-845-3646 marki@med.umich.edu
Contact: John T Arnedt, PhD 734-936-4955 tarnedt@med.umich.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03964974
Other Study ID Numbers  ICMJE HUM00151282
1R34DA047466-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mark A. Ilgen, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE Not Provided
PRS Account University of Michigan
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP