An interventional study of Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB) and Sleep Hygiene Education (SHE) in Insomnia Chronic and Cannabis Use, sponsored by University of Michigan. Completed at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-09-14.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
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 Hygiene Education (SHE) control 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.
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This study's enrollment of 57 is close to the median of 60 across 421 interventional studies indexed under Marijuana Abuse.
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Exclusion Criteria:
Behavioral: Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB)
Behavioral: Sleep Hygiene Education (SHE)
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.
Also known as: Cognitive Behavioral Therapy
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.
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.
Time frame: 16 Weeks
| Milestone | Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB) | Sleep Hygiene Education (SHE) |
|---|---|---|
| Started | 30 | 27 |
| Assigned and received intervention | 26 | 21 |
| 8 week follow up | 26 | 22 |
| 16 week follow up | 27 | 22 |
| Completed | 27 | 22 |
| Not completed | 3 | 5 |
| Withdrew: Lost to follow-up | 3 | 2 |
| Withdrew: Withdrawal by subject | 0 | 3 |
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.
| units on a scale | Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB) | Sleep Hygiene Education (SHE) |
|---|---|---|
| Longitudinal Model estimates at 8-week Follow-up | 11.2 ± 0.8 | 12.6 ± 0.8 |
| Longitudinal Model estimates at 16-week Follow-up | 6.0 ± 1.1 | 8.8 ± 1.0 |
Collected over 16 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CBTi-CB | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Sleep Education | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Age, Continuous(years) | CBTi-CB | Sleep Hygiene Education | Total |
|---|---|---|---|
| Mean | 36.7 ± 12.0 | 38.7 ± 13.7 | 37.6 ± 12.8 |
| Sex/Gender, Customized(Participants) | CBTi-CB | Sleep Hygiene Education | Total |
|---|---|---|---|
| Female | 23 | 20 | 43 |
| Male | 7 | 7 | 14 |
| Non-Binary | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | CBTi-CB | Sleep Hygiene Education | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 30 | 25 | 55 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | CBTi-CB | Sleep Hygiene Education | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 2 | 6 |
| White | 24 | 23 | 47 |
| More than one race | 1 | 2 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | CBTi-CB | Sleep Hygiene Education | Total |
|---|---|---|---|
| United States | 30 | 27 | 57 |
| Insomnia Severity Index (ISI)(units on a scale) | CBTi-CB | Sleep Hygiene Education | Total |
|---|---|---|---|
| Mean | 17.4 ± 4.5 | 16.2 ± 3.8 | 16.8 ± 4.2 |
| Frequency of Cannabis Use(Participants) | CBTi-CB | Sleep Hygiene Education | Total |
|---|---|---|---|
| Participants Who Used 2 - 3 Times/Week | 4 | 3 | 7 |
| Participants Who Used 4 or More Times/Week | 26 | 24 | 50 |
| Cannabis Use Per Day(Participants) | CBTi-CB | Sleep Hygiene Education | Total |
|---|---|---|---|
| Less Than Daily Use | 2 | 1 | 3 |
| 1 - 2 Times Per Day | 10 | 12 | 22 |
| 3 - 4 Times Per Day | 15 | 10 | 25 |
| 5 or More Times Per Day | 3 | 4 | 7 |
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