Affective Management Training for Cannabis Misuse

NCT03432013 | Completed

• 1 other identifier: 1R34DA044350
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

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.

Conditions

Cannabis Use Disorder

Outcome Measures

Primary Outcomes (1)

• Change from baseline THC consumption at 3 months and 6 months

  Urinalysis Toxicology Test primarily assessing levels of THC

  baseline, 3 months, and 6 month follow-up

Secondary Outcomes (3)

• 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

Study Arms (2)

SUD-CBT

ACTIVE COMPARATOR

Standard cognitive behavioral therapy for substance use disorder

Behavioral: SUD-CBT

CUD-AMT

EXPERIMENTAL

Experimental affective management training for cannabis use disorder specifically

Behavioral: CUD-AMT

Interventions

CUD-AMT BEHAVIORAL

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

Also known as: Cannabis Use Disorder-Affective Management Treatment

CUD-AMT

SUD-CBT BEHAVIORAL

Participants will receive traditional cognitive behavioral therapy for substance use disorder

Also known as: Substance Use Disorder-Cognitive Behavioral Therapy

SUD-CBT

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Matrix Institute on Addictions

Los Angeles, California, 90025, United States

Location

University of California-Los Angeles, Department of Psychiatry and Biobehavioral Sciences

Los Angeles, California, 90025, United States

Location

Study Officials

• Kate Wolitzky-Taylor, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 13, 2018
• Study Start: February 15, 2018
• Primary Completion: December 15, 2020
• Study Completion: June 30, 2021
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

US (2)