Integrated CBT for Cannabis Dependence With Co-occurring Anxiety Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Louisiana State University and A&M College
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Julia Buckner, Louisiana State University and A&M College
ClinicalTrials.gov Identifier:
NCT01875796
First received: June 10, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose

Cannabis dependence is the most common illicit substance dependence and people with cannabis dependence are highly vulnerable to anxiety disorders. The co-occurrence of anxiety disorders among those with cannabis dependence 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 dependence, 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 cannabis dependent anxious patients 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 cannabis dependence 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 cannabis dependence 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.


Condition Intervention Phase
Cannabis Dependence
Anxiety Disorders
Behavioral: Cognitive-Behavioral Therapy
Behavioral: Motivation Enhancement Therapy
Behavioral: Integrated Cannabis and Anxiety Reduction Treatment
Behavioral: False Safety Behavior Elimination Therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Integrated CBT for Cannabis Dependence With Co-occurring Anxiety Disorders

Resource links provided by NLM:


Further study details as provided by Louisiana State University and A&M College:

Primary Outcome Measures:
  • cannabis use [ Time Frame: change from baseline to weeks 6, 12, & 32 ] [ Designated as safety issue: No ]
  • cannabis-related problems [ Time Frame: change from baseline to weeks 6, 12, & 32 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • anxiety [ Time Frame: change from baseline to weeks 6, 12, & 32 ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: June 2013
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

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

Inclusion Criteria:

  1. Diagnosis of cannabis dependence
  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. The onset of the cannabis dependence must not be reported to precede that of the anxiety disorder.
  6. 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.

(f) Age between 18 and 65 years. (g) English language fluency. (h) 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.
  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: NCT01875796

Contacts
Contact: Julia D Buckner, PhD 225-578-5778 jbuckner@lsu.edu

Locations
United States, Louisiana
Louisiana State University Anxiety & Addictive Behaviors Clinic Recruiting
Baton Rouge, Louisiana, United States, 70803
Contact: Julia D Buckner, PhD    225-578-5778    jbuckner@lsu.edu   
Principal Investigator: Julia D Buckner, PhD         
Sponsors and Collaborators
Louisiana State University and A&M College
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
  More Information

Additional Information:
No publications provided

Responsible Party: Julia Buckner, Assistant Professor, Louisiana State University and A&M College
ClinicalTrials.gov Identifier: NCT01875796     History of Changes
Other Study ID Numbers: RDA031937A, 1R34DA031937-01
Study First Received: June 10, 2013
Last Updated: June 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Louisiana State University and A&M College:
cannabis
marijuana
anxiety
transdiagnostic
dual diagnosis

Additional relevant MeSH terms:
Anxiety Disorders
Marijuana Abuse
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on July 24, 2014