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Integrated CBT for Cannabis Dependence With Co-occurring Anxiety Disorders

Primary Purpose

Cannabis Dependence, Anxiety Disorders, Cannabis Use Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy
Motivation Enhancement Therapy
Integrated Cannabis and Anxiety Reduction Treatment
False Safety Behavior Elimination Therapy
Sponsored by
Louisiana State University and A&M College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Dependence focused on measuring cannabis, marijuana, anxiety, transdiagnostic, dual diagnosis, cannabis abuse, cannabis dependence, cannabis use disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Louisiana State University Anxiety & Addictive Behaviors Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cannabis & Anxiety Reduction Treatment

Motivation/cognitive-behavioral therapy

Arm Description

Cognitive-behavioral treatment program that integrates strategies to manage both cannabis use and anxiety with techniques to address motivation to change cannabis use.

Motivational Enhancement Therapy (MET) and cognitive-behavioral therapy (CBT) that includes techniques to address motivation to change cannabis use with strategies to manage use.

Outcomes

Primary Outcome Measures

cannabis use
cannabis-related problems

Secondary Outcome Measures

anxiety

Full Information

First Posted
June 10, 2013
Last Updated
August 24, 2016
Sponsor
Louisiana State University and A&M College
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01875796
Brief Title
Integrated CBT for Cannabis Dependence With Co-occurring Anxiety Disorders
Official Title
Integrated CBT for Cannabis Dependence With Co-occurring Anxiety Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louisiana State University and A&M College
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Dependence, Anxiety Disorders, Cannabis Use Disorder, Cannabis Abuse
Keywords
cannabis, marijuana, anxiety, transdiagnostic, dual diagnosis, cannabis abuse, cannabis dependence, cannabis use disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cannabis & Anxiety Reduction Treatment
Arm Type
Experimental
Arm Description
Cognitive-behavioral treatment program that integrates strategies to manage both cannabis use and anxiety with techniques to address motivation to change cannabis use.
Arm Title
Motivation/cognitive-behavioral therapy
Arm Type
Active Comparator
Arm Description
Motivational Enhancement Therapy (MET) and cognitive-behavioral therapy (CBT) that includes techniques to address motivation to change cannabis use with strategies to manage use.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy
Intervention Type
Behavioral
Intervention Name(s)
Motivation Enhancement Therapy
Intervention Type
Behavioral
Intervention Name(s)
Integrated Cannabis and Anxiety Reduction Treatment
Intervention Type
Behavioral
Intervention Name(s)
False Safety Behavior Elimination Therapy
Other Intervention Name(s)
Transdiagnostic anxiety disorder treatment
Primary Outcome Measure Information:
Title
cannabis use
Time Frame
change from baseline to weeks 6, 12, & 32
Title
cannabis-related problems
Time Frame
change from baseline to weeks 6, 12, & 32
Secondary Outcome Measure Information:
Title
anxiety
Time Frame
change from baseline to weeks 6, 12, & 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of cannabis use disorder An additional diagnosis of an anxiety disorder Patient reports that at least some of his/her cannabis use is aimed at reducing anxiety and/or for social facilitation. Patient reports that cannabis is his/her substance of choice for anxiety management. 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. Age between 18 and 65 years. English language fluency. Willing and able to provide written informed consent. Exclusion Criteria: Alcohol or illicit substance (non-cannabis) dependence. Cannabis use behavior sufficiently uncontrolled that proper participation in study protocol would likely be disrupted. History of schizophrenia, bipolar disorder, or organic brain syndrome. Prominent suicidal ideation with intent that is judged to be clinically significant. Mental retardation or another pervasive developmental disability (e.g., Asperger's Disorder). Sufficiently socially unstable as to preclude completion of study requirements (e.g., homeless). Prior simultaneous cognitive behavioral treatment for cannabis dependence and anxiety disorders. Legally mandated to receive substance abuse treatment. 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. Unwilling to maintain stable dose of regularly-dosed medications during the study Unwilling to cease PRN (pro re nata or "as needed") use of benzodiazepines or other fast-acting anxiolytics prior to entrance into social situations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia D Buckner, PhD
Organizational Affiliation
Louisiana State University Health Sciences Center in New Orleans
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael J Zvolensky, PhD
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louisiana State University Anxiety & Addictive Behaviors Clinic
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70803
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34264732
Citation
Buckner JD, Morris PE, Zvolensky MJ. Integrated cognitive-behavioral therapy for comorbid cannabis use and anxiety disorders: The impact of severity of cannabis use. Exp Clin Psychopharmacol. 2021 Jun;29(3):272-278. doi: 10.1037/pha0000456. Epub 2021 Apr 22.
Results Reference
derived
Links:
URL
https://www.surveymonkey.com/s/lsustudy
Description
online screening

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Integrated CBT for Cannabis Dependence With Co-occurring Anxiety Disorders

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