RECRUITING

Evaluation of a Brief Computerized and Smart Phone-based Intervention for Stress in Regular Cannabis Users

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The prevalence of daily cannabis use and Cannabis Use Disorder (CUD) has increased in the United States over the past two decades. Brief, computerized harm reduction interventions that target specific high-risk CUD populations could be an efficient approach to reducing CUD. Distress intolerance , which refers to the tendency to negatively appraise and escape aversive emotional states, is a risk factor associated with stress-related cannabis use motivation and CUD severity/chronicity. Thus, a brief, accessible, low-cost intervention that reduces distress intolerance in those with CUD and elevated distress intolerance could have a significant public health impact. This proposed project aims to optimize an existing two-session computerized distress tolerance intervention and test its impact on distress intolerance and cannabis use outcomes in a randomized controlled trial. Specifically, the intervention will be condensed to one-session, its active ingredient bolstered, and augmented with smart phone-delivered therapy reminders. After obtaining feedback on the modified Emotional Engagement Distress Tolerance Intervention in a small sample, the intervention's efficacy compared to a stringent, credible, time-matched health education control intervention will be tested in a randomized controlled trial in 80 cannabis users with CUD and high distress intolerance. Distress intolerance, cannabis use, and psychosocial functioning outcomes will be evaluated. As an exploratory aim, a wristworn device will be used to measure objective stress responding in the real-world during the intervention period. Our central hypothesis is that, compared to a control intervention, the Emotional Engagement Distress Tolerance Intervention will produce superior reductions distress intolerance, stress-related cannabis use motivation, disordered cannabis use, and psychosocial functioning.

Official Title

Refinement and Testing of a Brief Computerized and Smart Phone-based Intervention for Stress in Regular Cannabis Users

Quick Facts

Study Start:2024-06-04
Study Completion:2027-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06085222

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.

Ages Eligible for Study:18 Years to 30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Cannabis is the primary substance of abuse.
  2. * Clinical-level Distress intolerance Index score.
  3. * Current Cannabis Use Disorder diagnosis.
  4. * Near-daily to daily cannabis use in past-month and past 3 months.
  5. * Positive urine screen for THC
  6. * Detectable skin conductance level
  7. * Owns a smart phone
  8. * Primary smoked/vaporized delta-9 or delta-8 THC user
  1. * Presence of acute/major psychiatric disturbance
  2. * Current pregnancy
  3. * Change in psychotropic medication within the past month
  4. * Concurrently receiving treatment for cannabis use
  5. * Concurrently receiving dialectical behavior therapy or exposure-based therapy for emotional disorders
  6. * Planning to immediately quit using cannabis
  7. * EEG contraindications
  8. * Kidney disease

Contacts and Locations

Study Contact

Zoe Howell Project Coordinator, BS
CONTACT
850-644-2445
brains@psy.fsu.edu

Principal Investigator

Richard J Macatee, PhD
PRINCIPAL_INVESTIGATOR
Florida State University

Study Locations (Sites)

The BRAINS Lab at Florida State University
Tallahassee, Florida, 32306-4301
United States

Collaborators and Investigators

Sponsor: Florida State University

  • Richard J Macatee, PhD, PRINCIPAL_INVESTIGATOR, Florida State University

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 Registration Dates

Study Start Date2024-06-04
Study Completion Date2027-10-30

Study Record Updates

Study Start Date2024-06-04
Study Completion Date2027-10-30

Terms related to this study

Additional Relevant MeSH Terms

  • Cannabis Use Disorder