N/A N=57 Randomized Single-blind Treatment

Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis

Insomnia Chronic · Cannabis Use

Bottom Line

View on ClinicalTrials.gov: NCT03964974 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2022

Primary outcome: Primary: Change From Baseline Insomnia Severity Index Score at Study Completion — 11.2; 12.6; 6.0; 8.8 units on a scale — p=0.0041

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB) (Behavioral); Sleep Hygiene Education (SHE) (Behavioral)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Jul 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline Insomnia Severity Index Score at Study Completion	11.2; 12.6; 6.0; 8.8	0.0041 sig

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.

Eligibility 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 Tetrahydrocannabinol (THC),
Consistent access to a telephone, smart phone, 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03964974). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.