Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis
- Conditions
- Cannabis UseInsomnia Chronic
- Interventions
- Behavioral: Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB)Behavioral: Sleep Hygiene Education (SHE)
- Registration Number
- NCT03964974
- Lead Sponsor
- 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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- 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 Tetrahydrocannabinol (THC),
- Consistent access to a telephone, smart phone, laptop, or tablet
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB) Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB) - Sleep Hygiene Education (SHE) Sleep Hygiene Education (SHE) -
- Primary Outcome Measures
Name Time Method Change From Baseline Insomnia Severity Index Score at Study Completion 16 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. The range of the ISI is 0 to 28, with 28 corresponding to maximum severity.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Om of Medicine
🇺🇸Ann Arbor, Michigan, United States
Bloom City Club
🇺🇸Ann Arbor, Michigan, United States