Integrated CBT for Cannabis Dependence With Co-occurring Anxiety Disorders
2 other identifiers
interventional
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 10, 2013
CompletedFirst Posted
Study publicly available on registry
June 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedAugust 25, 2016
August 1, 2016
3.1 years
June 10, 2013
August 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
cannabis use
change from baseline to weeks 6, 12, & 32
cannabis-related problems
change from baseline to weeks 6, 12, & 32
Secondary Outcomes (1)
anxiety
change from baseline to weeks 6, 12, & 32
Study Arms (2)
Cannabis & Anxiety Reduction Treatment
EXPERIMENTALCognitive-behavioral treatment program that integrates strategies to manage both cannabis use and anxiety with techniques to address motivation to change cannabis use.
Motivation/cognitive-behavioral therapy
ACTIVE COMPARATORMotivational Enhancement Therapy (MET) and cognitive-behavioral therapy (CBT) that includes techniques to address motivation to change cannabis use with strategies to manage use.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Louisiana State University Anxiety & Addictive Behaviors Clinic
Baton Rouge, Louisiana, 70803, United States
Related Publications (1)
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.
PMID: 34264732DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julia D Buckner, PhD
Louisiana State University Health Sciences Center in New Orleans
- PRINCIPAL INVESTIGATOR
Michael J Zvolensky, PhD
University of Houston
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 10, 2013
First Posted
June 12, 2013
Study Start
June 1, 2013
Primary Completion
July 1, 2016
Last Updated
August 25, 2016
Record last verified: 2016-08