Targeting Maladaptive Reactivity to Negative Affect in Adolescent Cannabis Users

Affective Management Training for Cannabis Misuse



Sponsors


Source

University of California, Los Angeles

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Recruiting

Start Date

2018-02-15

Completion Date

2020-02-15

Primary Completion Date

2020-02-15

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Change from baseline THC consumption at 3 months and 6 months
baseline, 3 months, and 6 month follow-up

Secondary Outcome

Measure

Time Frame

Change from baseline in number of cannabis use days at 3 months and 6 months
baseline, 3 months, and 6 month follow-up
Change from baseline additional substance consumption at 3 months and 6 months
baseline, 3 months, and 6 month follow-up
Change in baseline cannabis abuse at 3 months and 6 months
Baseline, 3 months, and 6 month follow-up

Enrollment

80

Condition


Intervention

Intervention Type

Behavioral

Intervention Name


Description

Participants will be trained to manage their negative thoughts and emotions while also receiving treatment for cannabis misuse

Arm Group Label

CUD-AMT

Other Name

Cannabis Use Disorder-Affective Management Treatment


Intervention Type

Behavioral

Intervention Name


Description

Participants will receive traditional cognitive behavioral therapy for substance use disorder

Arm Group Label

SUD-CBT

Other Name

Substance Use Disorder-Cognitive Behavioral Therapy



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.

Gender

All

Minimum Age

18 Years

Maximum Age

25 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Kate Wolitzky-Taylor, PhD
Principal Investigator
University of California, Los Angeles

Overall Contact

Last Name

Kate Wolitzky-Taylor, PhD

Phone

310-267-5339

Phone Ext

75339

Email



Location

Facility

Status

Contact

Matrix Institute on Addictions
Los Angeles California 90025 United States
Recruiting
Last Name: Janice Stimson, Psy.D.
Phone: 310-478-8305
Email: [email protected]
University of California-Los Angeles, Department of Psychiatry and Biobehavioral Sciences
Los Angeles California 90025 United States
Recruiting
Last Name: Jason Grossman
Email: [email protected]
Last Name: Kate B Taylor, Ph.D.
Role: Principal Investigator

Location Countries

Country

United States


Verification Date

2018-02-01

Lastchanged Date

2018-02-06

Firstreceived Date

2018-01-30

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

University of California, Los Angeles

Investigator Full Name

Kate Taylor

Investigator Title

Principal Investigator


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

SUD-CBT

Arm Group Type

Active Comparator

Description

Standard cognitive behavioral therapy for substance use disorder


Arm Group Label

CUD-AMT

Arm Group Type

Experimental

Description

Experimental affective management training for cannabis use disorder specifically



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Nicholas Pistolesi, BS

Phone

310-267-5324

Phone Ext

75324

Email



Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

January 30, 2018

Study First Submitted Qc

February 6, 2018

Study First Posted

February 13, 2018

Last Update Submitted

February 6, 2018

Last Update Submitted Qc

February 6, 2018

Last Update Posted

February 13, 2018


ClinicalTrials.gov processed this data on February 13, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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