NCT01875796

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

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

3.1 years

First QC Date

June 10, 2013

Last Update Submit

August 24, 2016

Conditions

Keywords

cannabismarijuanaanxietytransdiagnosticdual diagnosiscannabis abusecannabis dependencecannabis use disorder

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

EXPERIMENTAL

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 TherapyBehavioral: Motivation Enhancement TherapyBehavioral: Integrated Cannabis and Anxiety Reduction TreatmentBehavioral: False Safety Behavior Elimination Therapy

Motivation/cognitive-behavioral therapy

ACTIVE COMPARATOR

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 TherapyBehavioral: Motivation Enhancement Therapy

Interventions

Cannabis & Anxiety Reduction TreatmentMotivation/cognitive-behavioral therapy
Cannabis & Anxiety Reduction TreatmentMotivation/cognitive-behavioral therapy
Cannabis & Anxiety Reduction Treatment
Also known as: Transdiagnostic anxiety disorder treatment
Cannabis & Anxiety Reduction Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Marijuana AbuseAnxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Julia D Buckner, PhD

    Louisiana State University Health Sciences Center in New Orleans

    PRINCIPAL INVESTIGATOR
  • Michael J Zvolensky, PhD

    University of Houston

    PRINCIPAL INVESTIGATOR

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

Locations