Integrated CBT for Cannabis Dependence With Co-occurring Anxiety Disorders

August 24, 2016 updated by: Julia Buckner, Louisiana State University and A&M College
This project tests the feasibility and utility of a novel, integrated approach to treatment of patients with cannabis use disorder (CUD) and anxiety disorders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cannabis use disorder (CUD) is the most common illicit substance dependence and people with CUD are highly vulnerable to anxiety disorders. The co-occurrence of anxiety disorders among those with CUD is a pressing public health matter given elevated anxiety is related to poorer cannabis treatment outcomes. Cannabis-related problems among those with anxiety disorders may be maintained by a reliance on cannabis to manage anxiety. Investigations of the treatment of these conditions when they co-occur have been virtually absent. Motivation enhancement therapy (MET) combined with cognitive-behavioral therapy (CBT) is an efficacious intervention for cannabis CUD, yet outcomes are highly limited for anxious patients. Transdiagnostic anxiety treatments can facilitate the treatment of patients with anxiety psychopathology regardless of the specific type of anxiety disorder. One such treatment, False Safety Behavior Elimination Treatment (FSET), may be particularly useful with anxious patients with CUD as it focuses on the elimination of behaviors that may be effective in decreasing anxiety in the short-term, but can maintain and even exacerbate anxiety in the long-term (i.e., false safety behaviors). The use of cannabis to manage anxiety can, therefore, be targeted in such a treatment. This project tests the feasibility and utility of a novel, integrated approach to treatment of patients with CUD and anxiety disorders. Phase I of the project includes development and refinement of a specialized group protocol (i.e., Integrated Cannabis and Anxiety Reduction Treatment or ICART) for integrating MET-CBT for CUD with FSET. The initial protocol will be modified based on the experience gained during group treatment with the integrated treatment. Phase II will be a randomized controlled trial examining the relative efficacy of the refined ICART treatment versus MET-CBT alone. After post-treatment assessments, the ICART group will be followed for 3 months to examine maintenance of gains; the participants originally assigned to the control condition will be offered ICART. It is hypothesized that ICART will produce better outcomes than the control.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70803
        • Louisiana State University Anxiety & Addictive Behaviors Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of cannabis use disorder
  2. An additional diagnosis of an anxiety disorder
  3. Patient reports that at least some of his/her cannabis use is aimed at reducing anxiety and/or for social facilitation.
  4. Patient reports that cannabis is his/her substance of choice for anxiety management.
  5. Concurrent use of psychotropic medications (e.g., selective serotonin reuptake inhibitors) is permitted as long as patients have been on a stable dose for at least three months prior to entering the study and they are willing to remain stable on their medication for the duration of treatment.
  6. Age between 18 and 65 years.
  7. English language fluency.
  8. Willing and able to provide written informed consent.

Exclusion Criteria:

  1. Alcohol or illicit substance (non-cannabis) dependence.
  2. Cannabis use behavior sufficiently uncontrolled that proper participation in study protocol would likely be disrupted.
  3. History of schizophrenia, bipolar disorder, or organic brain syndrome.
  4. Prominent suicidal ideation with intent that is judged to be clinically significant.
  5. Mental retardation or another pervasive developmental disability (e.g., Asperger's Disorder).
  6. Sufficiently socially unstable as to preclude completion of study requirements (e.g., homeless).
  7. Prior simultaneous cognitive behavioral treatment for cannabis dependence and anxiety disorders.
  8. Legally mandated to receive substance abuse treatment.
  9. Report of current participation in or intent to participate in an additional (i.e., treatments other than MET-CBT or MET alone) anxiety or substance abuse treatment method during the course of the study.
  10. Unwilling to maintain stable dose of regularly-dosed medications during the study
  11. Unwilling to cease PRN (pro re nata or "as needed") use of benzodiazepines or other fast-acting anxiolytics prior to entrance into social situations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cannabis & Anxiety Reduction Treatment
Cognitive-behavioral treatment program that integrates strategies to manage both cannabis use and anxiety with techniques to address motivation to change cannabis use.
Behavioral: Cognitive-Behavioral Therapy
Behavioral: Motivation Enhancement Therapy
Behavioral: Integrated Cannabis and Anxiety Reduction Treatment
Behavioral: False Safety Behavior Elimination Therapy
Other Names:
  • Transdiagnostic anxiety disorder treatment
ACTIVE_COMPARATOR: Motivation/cognitive-behavioral therapy
Motivational Enhancement Therapy (MET) and cognitive-behavioral therapy (CBT) that includes techniques to address motivation to change cannabis use with strategies to manage use.
Behavioral: Cognitive-Behavioral Therapy
Behavioral: Motivation Enhancement Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cannabis use
Time Frame: change from baseline to weeks 6, 12, & 32
change from baseline to weeks 6, 12, & 32
cannabis-related problems
Time Frame: change from baseline to weeks 6, 12, & 32
change from baseline to weeks 6, 12, & 32

Secondary Outcome Measures

Outcome Measure
Time Frame
anxiety
Time Frame: change from baseline to weeks 6, 12, & 32
change from baseline to weeks 6, 12, & 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louisiana State University and A&M College

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Julia D Buckner, PhD, Louisiana State University Health Sciences Center in New Orleans
  • Principal Investigator: Michael J Zvolensky, PhD, University of Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

June 10, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (ESTIMATE)

June 12, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 25, 2016

Last Update Submitted That Met QC Criteria

August 24, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDA031937A
  • 1R34DA031937-01 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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