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

This study has been terminated.
(Principle Investigator as left government service)
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02102230
First received: March 25, 2014
Last updated: July 17, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention
Marijuana Abuse Sleep Initiation and Maintenance Disorders Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) Behavioral: quasi-desensitization Behavioral: Cognitive Behavioral Therapy for Insomnia plus Mobile App

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Impact of CBT-I on Cannabis Cessation Outcomes

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • change in cannabis use frequency over time [ Time Frame: baseline, 6-weeks post-baseline, 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit ]
    Measures will include the Timeline Followback for cannabis

  • point prevalence abstinence over the three post-quit attempt assessments [ Time Frame: 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit ]
    point prevalence abstinence will be assessed using the Timeline Follow-back measure for cannabis

  • Change in Self-reported Sleep Quality over time [ Time Frame: 2-weeks post-quit, 4-weeks post-quit, 6-months post-quit ]
    Self-reported sleep quality will be measured using the Consensus Sleep Diary

  • Change in Objective Sleep Quality over time [ Time Frame: 2-weeks post-quit, 4-weeks post-quit, 6-months post-quit ]
    Objective sleep quality will be measured via actigraphy


Enrollment: 113
Actual Study Start Date: November 3, 2014
Study Completion Date: March 24, 2017
Primary Completion Date: March 24, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT-I-MA
Group CBT-I with Adjunct Mobile Application
Behavioral: Cognitive Behavioral Therapy for Insomnia plus Mobile App
Group-based behavioral intervention for insomnia with adjunct information provided by mobile application
Other Name: CBT-I-MA
Active Comparator: CBT-I
Group CBT-I only
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
Behavioral intervention for insomnia
Other Name: CBT-I
Placebo Comparator: PC
quasi-desensitization
Behavioral: quasi-desensitization
behavioral placebo control
Other Name: placebo intervention

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02102230

Locations
United States, California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Kimberly A Babson, PhD MA BS VA Palo Alto Health Care System, Palo Alto, CA
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02102230     History of Changes
Other Study ID Numbers: CLIN-016-13F
Study First Received: March 25, 2014
Last Updated: July 17, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Sleep Initiation and Maintenance Disorders
marijuana abuse
Veterans

Additional relevant MeSH terms:
Marijuana Abuse
Sleep Initiation and Maintenance Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 23, 2017