Clinical trial NCT02102230: CBT-I for Cannabis Use
Official title: The Impact of CBT-I on Cannabis Cessation Outcomes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Marijuana Abuse
Sleep Initiation and Maintenance Disorders
Keywords: Sleep Initiation and Maintenance Disorders
marijuana abuse
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-04-02
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy of a group-based behavioral sleep intervention, and the incremental benefit provided by an adjunct sleep mobile app, on cannabis and sleep outcomes among cannabis dependent Veterans.

Detailed description: The Prevalence of cannabis use disorder (CUD) has been steadily increasing within the Veteran Health Administration (VHA), along with the related significant physical, cognitive, and psychological sequelae. Even in patients with a strong motivation to quit and the presence of empirically-supported interventions, Veterans who receive treatment for CUD have high rates of lapse (63% by 6-months post-treatment) and relapse (71% within 6-months post-treatment). Thus, identifying strategies to improve response to CUD treatment is in the interest of all VHA stakeholders.

Disturbed sleep is common among individuals with CUD and has been shown to result in increased rates of lapse/relapse to cannabis. Providing a behavioral sleep intervention within the context of CUD treatment, and prior to a cessation attempt, has the potential to improve these cessation outcomes.

Cognitive behavioral therapy for insomnia (CBT-I) is a well-established first-line treatment for insomnia. While CBT-I is being disseminated throughout VHA, it is rarely received by Veterans with substance use disorders (SUDs) and, among those that do receive it, it is almost always delivered following a cessation attempt. While CBT-I has been shown to be an effective treatment for improving sleep among individuals with insomnia and co-occurring conditions, including SUDs, there has yet to be an investigation of the impact of providing CBT-I prior to CUD treatment with the goal of improving cessation outcomes. In addition, the development of an adjunct behavioral intervention delivered via mobile app technology within VA holds great promise to bolster outcomes.

The current study seeks to fill this gap by conducting a randomized prospective study designed to evaluate the efficacy of CBT-I, as well as the incremental benefit of including an adjunct sleep mobile app (CBT-I-MA), on both cannabis and sleep outcomes among Veterans with CUD.

Eligibility criteria: Inclusion Criteria:

To be included in the current study individuals must

* be a Veteran 18 years or older
* meet Diagnostic and Statistical Manual of Mental Disorders-5 diagnostic criteria for cannabis use disorder;
* meet Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria for insomnia;

Exclusion Criteria:

Individuals will be excluded based on evidence of the following:

* inability to provide fully-informed written consent to participate;
* history of, or current, psychotic symptoms;
* current pregnancy;
* Sleep apnea (\>5 on the STOP-Bang assessment);
* active suicidal/homicidal intent.

Primary outcomes:
measure: Change in Cannabis Use Frequency Over Time
timeFrame: baseline, 6-weeks post-baseline, 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit
measure: Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments
timeFrame: 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit
measure: Change in Self-reported Sleep Quality Over Time
timeFrame: 2-weeks post-quit, 4-weeks post-quit, 6-months post-quit
measure: Change in Objective Sleep Quality Over Time
timeFrame: 2-weeks post-quit, 4-weeks post-quit, 6-months post-quit
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Kimberly A Babson, PhD MA BS
role: PRINCIPAL_INVESTIGATOR
References: