Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Not yet recruiting
First Posted : May 27, 2019
Last Update Posted : September 5, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mark A. Ilgen, University of Michigan

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
Insomnia Chronic Cannabis Use Behavioral: Cognitive Behavioral Therapy for Insomnia in Cannabis Users Behavioral: Sleep Education Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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 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.




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Mark A Ilgen, PhD 734-845-3646 marki@med.umich.edu
Contact: John T Arnedt, PhD 734-936-4955 tarnedt@med.umich.edu

Sponsors and Collaborators
University of Michigan
National Institute on Drug Abuse (NIDA)

Additional Information:
Publications:
Substance Abuse and Mental Health Services Administration. Results from the 2009 National Survey on Drug Use and Health: National findings. Vol HHS Publication No. SMA 10-4856Findings. Rockville, MD.: Office of Applied Studies; 2010.
Substance A, Mental Health Services Administration CfBHS, Quality. Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings. Rockville, MD: United States Department of Health and Human Services, Substance Abuse and Mental Health Services Administration;2014.
Gillin J, Kotin J, Post R. Sleep during one week of administration of Δ-9 tetrahydrocanabinol to psychiatric patients. J Sleep Res. 1972;1:44.
Association AP. Diagnostic and Statistical Manual of Mental Disorders (DSM-5®): American Psychiatric Pub; 2013.
Morin CM. Insomnia: Psychological assessment and management. New York: The Guilford Press; 1993.
Bootzin RR, Nicassio PM. Behavioral treatments for insomnia. In: Hersen M, Eissler R, Miller P, eds. Progress in Behavior Modification. Vol 6. New York, NY: Academic Press; 1978:1-45.
Fellman-Couture C, Pillai V, Arnedt JT, et al. Long-term Efficacy of Cognitive Behavior Therapy for Menopausal Insomnia. Sleep. Denver, CO2016.
Perlis M, Jungquist C, Smith M, Posner D. Cognitive behavioral therapy for insomnia: a session-by-session guide: Springer, New York; 2005.
Iber C, Ancoli-Israel S, Chesson A, Quan SFftAAoSM. The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications, 1st ed. Westchester, Illinois: American Academy of Sleep Medicine; 2007.
Berry RB, R. Brooks, C. E. Gamaldo, et al. The AASM manual for the scoring of sleep and associated events: rules, terminology and technical specifications, Version 2.1. Darien, IL, : American Academy of Sleep Medicine; 2014.
Jasper HH. The ten twenty electrode system of the international federation. Electroencephalography and clinical neurophysiology. 1958;10:371-375.
Smith GE, Ross RL, Rost KM. Psychiatric outcomes module: substance abuse outcomes module (SAOM). In: Sederer LI, Dickey B, eds. Outcome assessment in clinical practice. Baltimore, MD: Williams and Wilkins; 1996:85-88.
Lacks P. Behavioral Treatment for Persistent Insomnia. New York, NY: Pergamon Press; 1987.
Fichten CS, Libman E, Creti L, et al. Role of thoughts during nocturnal awake times in the insomnia experience of older adults. Cognitive Therapy and Research. 2001;25(6):665-692.
Simons J, Correia CJ, Carey KB, Borsari BE. Validating a five-factor marijuana motives measure: Relations with use, problems, and alcohol motives. Journal of Counseling Psychology. 1998;45(3):265.
Sobell LC, Sobell MB. Timeline follow-back. Measuring alcohol consumption: Springer; 1992:41-72.
Little RJ, Rubin DB. Statistical analysis with missing data. New York: Wiley & Sons; 1987.

Layout table for additonal information
Responsible Party: Mark A. Ilgen, Associate Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT03964974     History of Changes
Other Study ID Numbers: HUM00151282
1R34DA047466-01 ( U.S. NIH Grant/Contract )
First Posted: May 27, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Marijuana Abuse
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders