Ignite Creation Date:
2024-05-06 @ 1:14 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03964974
Status:
COMPLETED
Last Update Posted:
2022-09-14
First Post:
2019-05-17
Brief Title:
Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CannSleep
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 andor 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 sleepinsomnia 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 frequencyquantity 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R34DA047466-01 | NIH | None | httpsreporternihgovquickSearch1R34DA047466-01 |