The Impact of CBT-I on Cannabis Cessation Outcomes

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT02102230
First received: March 25, 2014
Last updated: March 28, 2014
Last verified: March 2014
  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, in improving cannabis treatment 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Department of Veterans Affairs:

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Objective sleep quality will be measured via actigraphy


Estimated Enrollment: 168
Study Start Date: July 2014
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: December 2018 (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; placebo control used for sleep interventions
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 cessation and sleep outcomes among Veterans with CUD.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be included in the current study individuals must

  • be a Veteran 18 years or older scheduled to begin outpatient SUD treatment at the VA Palo Alto Health Care System;
  • 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;
  • endorse a motivation to quit, evidenced by actively thinking about/or having a plan to quit in the next month; and
  • be willing to agree to a quit day which will occur after completion of the treatment/placebo group.

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;
  • apnea hypopnea index (AHI) >15, indicative of moderate to severe sleep apnea; and
  • 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

Contacts
Contact: Kimberly Babson, PhD MA BS (650) 493-5000 ext 23827 Kimberly.Babson@va.gov

Locations
United States, California
VA Palo Alto Health Care System, Palo Alto, CA Not yet recruiting
Palo Alto, California, United States, 94304-1290
Contact: Kimberly Babson, PhD MA BS    650-493-5000 ext 23827    Kimberly.Babson@va.gov   
Principal Investigator: Kimberly Babson, PhD MA BS         
Sponsors and Collaborators
Investigators
Principal Investigator: Kimberly Babson, PhD MA BS VA Palo Alto Health Care System, Palo Alto, CA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT02102230     History of Changes
Other Study ID Numbers: CLIN-016-13F
Study First Received: March 25, 2014
Last Updated: March 28, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Sleep Initiation and Maintenance Disorders
marijuana abuse
Veterans

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

ClinicalTrials.gov processed this record on August 28, 2014