Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Affective Management Training for Cannabis Misuse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03432013
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kate Taylor, University of California, Los Angeles

Brief Summary:
Emerging evidence suggests that it is not the negative affect per se but underlying maladaptive cognitive, behavioral, and emotional responses to it that put an individual at risk of pathological substance use. Maladaptive reactivity to negative affect may account for the association between substance-use and emotional disorders and may contribute to poor treatment outcomes for Substance Use Disorder. Thus, teaching adolescents and young adults (herein referred to as "adolescents") skills to manage negative affect may improve therapeutic outcomes of treatment for substance use disorder. Cannabis-use disorder (CUD) among adolescents is a prevalent and growing public health concern. Maladaptive reactivity to negative affect contributes to the maintenance of CUD and accounts for the associations between symptoms of emotional disorders and cannabis use. Still, maladaptive reactivity to negative affect has not yet been targeted in an intervention for CUD. Thus, the overarching aim of this proposal is to develop and pilot test a treatment for CUD that emphasizes the reduction of maladaptive responding to negative affect in adolescents. Participants will be placed in either a standard cognitive behavioral therapy for CUD, or the proposed affective management therapy. The investigators hypothesize that affective management training will yield greater reductions in the participants' use of cannabis, as well as greater improvements to the participants' negative thoughts and emotions, compared to the standard cognitive behavioral therapy.

Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Behavioral: CUD-AMT Behavioral: SUD-CBT Not Applicable

Detailed Description:
This project aims to develop and evaluate a behavioral intervention for adolescent cannabis use disorder that emphasizes adaptive responding to negative affective symptoms (e.g., depression, anxiety). Maladaptive cognitive, behavioral, and emotional reactions to negative affect are associated with substance use and substance use problems (including cannabis). Adolescence and young adulthood represents a developmental period in which the regulation of negative emotions is still being developed, as well as a time when cannabis use is prevalent and cannabis use disorders onset. Thus, developing and evaluating cannabis use disorder interventions that emphasize the improvement of responding to negative affect may be particularly important for this developmental period. First, the investigators developed an intervention that weaves skills and strategies for responding adaptively to negative affect, particularly as it relates to high-risk times for cannabis craving and use, into an evidence-based substance use disorder intervention for individuals in late adolescence and early adulthood. After delivering it to a small sample of participants, the investigators will gather feedback to guide refinements to the intervention. After refining the intervention, which will be a 12-session individual treatment, we will conduct the pilot randomized clinical trial. Participants (N = 80) aged 18-25 with cannabis use disorder and elevations in constructs representing maladaptive reactivity to negative affect (i.e., high anxiety sensitivity, low distress tolerance, or facets of emotion dysregulation including high emotional suppression and low cognitive reappraisal ability) will be randomized to receive either: (a) standard cognitive behavioral therapy for adolescent substance use disorders (SUD-CBT) or (b) the novel intervention we develop, affective management training for cannabis use disorders (CUD-AMT). Participants will be assessed at baseline, post-treatment, and a 6-month follow-up assessment on self-report and behavioral indices of the targeted mechanisms, as well as on substance use outcomes (both cannabis-specific and substances more broadly defined). A sub-set of participants (n = 50) will also undergo pre- and post-treatment fMRI assessment to evaluate whether neural indices of emotion regulation are improved to a greater extent in CUD-AMT compared to SUD-CBT. Cannabis use disorder is the most prevalent substance use disorder among adolescents and young adults, and often leads to the use of other substances. Negative affect and disorders associated with high negative affect (i.e., anxiety and unipolar mood disorders) are highly prevalent and associated with significant substance use disorder comorbidity. Targeting a process that is still malleable in late adolescence and young adulthood and that is associated with the maintenance of substance use disorders has the potential to reduce the burden of substance use disorders in this population, thus making a significant public health impact.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeting Maladaptive Reactivity to Negative Affect in Adolescent Cannabis Users
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : February 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Active Comparator: SUD-CBT
Standard cognitive behavioral therapy for substance use disorder
Behavioral: SUD-CBT
Participants will receive traditional cognitive behavioral therapy for substance use disorder
Other Name: Substance Use Disorder-Cognitive Behavioral Therapy

Experimental: CUD-AMT
Experimental affective management training for cannabis use disorder specifically
Behavioral: CUD-AMT
Participants will be trained to manage their negative thoughts and emotions while also receiving treatment for cannabis misuse
Other Name: Cannabis Use Disorder-Affective Management Treatment




Primary Outcome Measures :
  1. Change from baseline THC consumption at 3 months and 6 months [ Time Frame: baseline, 3 months, and 6 month follow-up ]
    Urinalysis Toxicology Test primarily assessing levels of THC


Secondary Outcome Measures :
  1. Change from baseline in number of cannabis use days at 3 months and 6 months [ Time Frame: baseline, 3 months, and 6 month follow-up ]
    Timeline Followback assesses number of substance use days. At the time of each assessment, the period of time examined is the "past 30 days

  2. Change from baseline additional substance consumption at 3 months and 6 months [ Time Frame: baseline, 3 months, and 6 month follow-up ]
    Urinalysis Toxicology Test used to test for additional substances other than THC

  3. Change in baseline cannabis abuse at 3 months and 6 months [ Time Frame: Baseline, 3 months, and 6 month follow-up ]
    Cannabis Abuse Screening Test assess cannabis-related problems by self-report



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • must be between ages of 18-25; meet diagnostic criteria for cannabis use disorder; score > 1 Standard deviation above the norm on the Positive and Negative Affect Scale-Negative Affect Subscale, and > 1 standard deviation above the norm on either the Anxiety Sensitivity Index, the Distress Tolerance Scale, or the Emotion Regulation Questionnaire; either not on medication or stabilized on medication; fluent in English; and must satisfy usual fMRI criteria.

Exclusion Criteria:

  • marked cognitive impairment; moderate to severe suicidality; unstable manic or psychotic symptoms; or primary substance of dependence is not cannabis.

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): NCT03432013


Contacts
Layout table for location contacts
Contact: Kate Wolitzky-Taylor, PhD 310-267-5339 ext 75339 KBTaylor@mednet.ucla.edu
Contact: Nicholas Pistolesi, BS 310-267-5324 ext 75324 npistolesi@mednet.ucla.edu

Locations
Layout table for location information
United States, California
Matrix Institute on Addictions Recruiting
Los Angeles, California, United States, 90025
Contact: Janice Stimson, Psy.D.    310-478-8305    jstimson@matrixinstitute.org   
University of California-Los Angeles, Department of Psychiatry and Biobehavioral Sciences Recruiting
Los Angeles, California, United States, 90025
Contact: Jason Grossman       jtgrossman@ucla.edu   
Principal Investigator: Kate B Taylor, Ph.D.         
Sponsors and Collaborators
University of California, Los Angeles
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: Kate Wolitzky-Taylor, PhD University of California, Los Angeles

Layout table for additonal information
Responsible Party: Kate Taylor, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03432013     History of Changes
Other Study ID Numbers: 1R34DA044350 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders