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Affective Management Training for Cannabis Misuse

Primary Purpose

Cannabis Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CUD-AMT
SUD-CBT
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use Disorder

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Matrix Institute on Addictions
  • University of California-Los Angeles, Department of Psychiatry and Biobehavioral Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SUD-CBT

CUD-AMT

Arm Description

Standard cognitive behavioral therapy for substance use disorder

Experimental affective management training for cannabis use disorder specifically

Outcomes

Primary Outcome Measures

Change from baseline THC consumption at 3 months and 6 months
Urinalysis Toxicology Test primarily assessing levels of THC

Secondary Outcome Measures

Change from baseline in number of cannabis use days at 3 months and 6 months
Timeline Followback assesses number of substance use days. At the time of each assessment, the period of time examined is the "past 30 days
Change from baseline additional substance consumption at 3 months and 6 months
Urinalysis Toxicology Test used to test for additional substances other than THC
Change in baseline cannabis abuse at 3 months and 6 months
Cannabis Abuse Screening Test assess cannabis-related problems by self-report

Full Information

First Posted
January 30, 2018
Last Updated
May 16, 2022
Sponsor
University of California, Los Angeles
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03432013
Brief Title
Affective Management Training for Cannabis Misuse
Official Title
Targeting Maladaptive Reactivity to Negative Affect in Adolescent Cannabis Users
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SUD-CBT
Arm Type
Active Comparator
Arm Description
Standard cognitive behavioral therapy for substance use disorder
Arm Title
CUD-AMT
Arm Type
Experimental
Arm Description
Experimental affective management training for cannabis use disorder specifically
Intervention Type
Behavioral
Intervention Name(s)
CUD-AMT
Other Intervention Name(s)
Cannabis Use Disorder-Affective Management Treatment
Intervention Description
Participants will be trained to manage their negative thoughts and emotions while also receiving treatment for cannabis misuse
Intervention Type
Behavioral
Intervention Name(s)
SUD-CBT
Other Intervention Name(s)
Substance Use Disorder-Cognitive Behavioral Therapy
Intervention Description
Participants will receive traditional cognitive behavioral therapy for substance use disorder
Primary Outcome Measure Information:
Title
Change from baseline THC consumption at 3 months and 6 months
Description
Urinalysis Toxicology Test primarily assessing levels of THC
Time Frame
baseline, 3 months, and 6 month follow-up
Secondary Outcome Measure Information:
Title
Change from baseline in number of cannabis use days at 3 months and 6 months
Description
Timeline Followback assesses number of substance use days. At the time of each assessment, the period of time examined is the "past 30 days
Time Frame
baseline, 3 months, and 6 month follow-up
Title
Change from baseline additional substance consumption at 3 months and 6 months
Description
Urinalysis Toxicology Test used to test for additional substances other than THC
Time Frame
baseline, 3 months, and 6 month follow-up
Title
Change in baseline cannabis abuse at 3 months and 6 months
Description
Cannabis Abuse Screening Test assess cannabis-related problems by self-report
Time Frame
Baseline, 3 months, and 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate Wolitzky-Taylor, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Matrix Institute on Addictions
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
University of California-Los Angeles, Department of Psychiatry and Biobehavioral Sciences
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States

12. IPD Sharing Statement

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Affective Management Training for Cannabis Misuse

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