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Integrated CBT for Cannabis Dependence With Co-occurring Anxiety Disorders

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ClinicalTrials.gov Identifier: NCT01875796
Recruitment Status : Completed
First Posted : June 12, 2013
Last Update Posted : August 25, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Julia Buckner, Louisiana State University and A&M College

Study Description
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Brief Summary:
This project tests the feasibility and utility of a novel, integrated approach to treatment of patients with cannabis use disorder (CUD) and anxiety disorders.

Condition or disease Intervention/treatment Phase
Cannabis Dependence Anxiety Disorders Cannabis Use Disorder Cannabis Abuse Behavioral: Cognitive-Behavioral Therapy Behavioral: Motivation Enhancement Therapy Behavioral: Integrated Cannabis and Anxiety Reduction Treatment Behavioral: False Safety Behavior Elimination Therapy Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Integrated CBT for Cannabis Dependence With Co-occurring Anxiety Disorders
Study Start Date : June 2013
Actual Primary Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Marijuana

Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. cannabis use [ Time Frame: change from baseline to weeks 6, 12, & 32 ]
  2. cannabis-related problems [ Time Frame: change from baseline to weeks 6, 12, & 32 ]

Secondary Outcome Measures :
  1. anxiety [ Time Frame: change from baseline to weeks 6, 12, & 32 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01875796


Locations
United States, Louisiana
Louisiana State University Anxiety & Addictive Behaviors Clinic
Baton Rouge, Louisiana, United States, 70803
Sponsors and Collaborators
Louisiana State University and A&M College
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
More Information
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Additional Information:
online screening  This link exits the ClinicalTrials.gov site

Responsible Party: Julia Buckner, Associate Professor, Louisiana State University and A&M College
ClinicalTrials.gov Identifier: NCT01875796     History of Changes
Other Study ID Numbers: RDA031937A
1R34DA031937-01 ( U.S. NIH Grant/Contract )
First Posted: June 12, 2013    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016

Keywords provided by Julia Buckner, Louisiana State University and A&M College:
cannabis
marijuana
anxiety
transdiagnostic
 dual diagnosis
cannabis abuse
cannabis dependence
cannabis use disorder

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Marijuana Abuse
Pathologic Processes
 Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders