NCT03964974: CannSleep

Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis

Completed NA Results posted Last updated 14 September 2022

What this trial tests

NA trial testing Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB) in Insomnia Chronic in 57 participants. Completed in 13 July 2021.

Timeline

10 February 2020

Primary endpoint
13 July 2021

13 July 2021

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	57
Start date	10 February 2020
Primary completion	13 July 2021
Estimated completion	13 July 2021
Sites	2 locations across United States

Drugs / interventions tested

• Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB)
• Sleep Hygiene Education (SHE)

Conditions studied

• Insomnia Chronic — all drugs for Insomnia Chronic →
• Cannabis Use — all drugs for Cannabis Use →

Sponsor

University of Michigan

Who can join

21 and older, any sex, with Insomnia Chronic or Cannabis Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline Insomnia Severity Index Score at Study Completion Primary · 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.

Longitudinal Model estimates at 8-week Follow-up

Group	Value	95% CI
Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB)	11.2	± 0.8
Sleep Hygiene Education (SHE)	12.6	± 0.8

Longitudinal Model estimates at 16-week Follow-up

Group	Value	95% CI
Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB)	6.0	± 1.1
Sleep Hygiene Education (SHE)	8.8	± 1.0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cognitive behavioral therapy for insomnia to reduce cannabis use: Results from a pilot randomized controlled trial.
   Todd Arnedt J, Conroy DA, Stewart H, Yeagley E, et al · · 2023 · cited 7× · PMID 36940598 · DOI 10.1016/j.drugalcdep.2023.109835