CBT-I for Cannabis Use (CBT-I-CU)

VA Office of Research and Development

Status: Terminated

Conditions: Sleep Initiation and Maintenance Disorders; Marijuana Abuse

Treatments: Behavioral: Desensitization Treatment for Insomnia; Behavioral: Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA); Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02102230

CLIN-016-13F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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111 participants in 3 patient groups, including a placebo group

CBT-I

Experimental group

Description:

Group Cognitive-Behavioral Therapy for Insomnia (CBT-I)

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

CBT-I-MA

Active Comparator group

Description:

Group Cognitive-Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)

PC

Placebo Comparator group

Description:

Desensitization Treatment for Insomnia (DTI)

Treatment:

Behavioral: Desensitization Treatment for Insomnia