The Impact of CBT-I on Cannabis Cessation Outcomes



Status:Recruiting
Conditions:Insomnia Sleep Studies, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2014
End Date:July 2019
Contact:Kimberly A Babson, PhD MA BS
Email:Kimberly.Babson@va.gov
Phone:(650) 493-5000

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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.

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.

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.
We found this trial at
1
site
Palo Alto, California 94304
Principal Investigator: Kimberly A Babson, PhD MA BS
Phone: 650-493-5000
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mi
from
Palo Alto, CA
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