Affective Management Training for Cannabis Misuse

May 16, 2022 updated by: Kate Taylor, University of California, Los Angeles

Targeting Maladaptive Reactivity to Negative Affect in Adolescent Cannabis Users

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Matrix Institute on Addictions
      • Los Angeles, California, United States, 90025
        • University of California-Los Angeles, Department of Psychiatry and Biobehavioral Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Cannabis Use Disorder-Affective Management Treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline, 3 months, and 6 month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
baseline, 3 months, and 6 month follow-up
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
baseline, 3 months, and 6 month follow-up
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
Baseline, 3 months, and 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kate Wolitzky-Taylor, PhD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R34DA044350 (NIH)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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