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

NCT06085222 | Recruiting

• 2 other identifiers: STUDY000063461R34DA057733-01A1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cannabis Use Disorder

Outcome Measures

Primary Outcomes (13)

• Therapy Evaluation Questionnaire

  acceptability/feasibility (credibility subscale range 3-27; expectancy item range 0%-100%; higher scores indicate better outcome)

  Immediately after intervention session

• Treatment Satisfaction Questionnaire

  acceptability/feasibility (range 0-84; higher scores indicate better outcome)

  Post-Intervention (20 days after intervention session)

• Change in perceived distress intolerance from baseline through follow-up

  Distress Intolerance Index (range 0-40; higher scores indicate worse outcome) to assess perceived distress intolerance via self-report

  Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up

• Change in behavioral distress intolerance from baseline through follow-up

  Mirror-Tracing Persistence Task to assess behavioral distress intolerance via computerized task

  Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up

• Change in laboratory stress-induced cannabis craving from baseline through post-intervention

  Change in Marijuana Craving Questionnaire (range 11-77; higher scores indicate worse outcome) after Mannheim Multicomponent Stress Test at post-intervention compared to baseline

  Baseline, Post-Intervention (20 days after intervention session)

• Change in laboratory stress-induced neural reactivity to cannabis cues (assessed via the electroencephalography [EEG]-recorded late positive potential) from baseline through post-intervention

  Change in Late Positive Potential to Cannabis Cues after Mannheim Multicomponent Stress Test at post-intervention compared to baseline

  Baseline, Post-Intervention (20 days after intervention session)

• Change in real-world stress-elicited cannabis use from baseline to post-intervention

  Change in stress-\>cannabis use slopes derived from ecological momentary assessment from baseline through post-intervention

  Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session)

• Change in cannabis use frequency from baseline through follow-up

  Change in cannabis use frequency (measured via timeline follow-back) from baseline through four-month follow-up

  Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up

• Change in urine tetrahydrocannabinol [THC] metabolite concentration from baseline through follow-up

  Change in urinary THC metabolite concentration (measured via ultra high performance liquid chromatography \[UHPLC\]) from baseline through four-month follow-up

  Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up

• Change in self-reported cannabis use problems from baseline through follow-up

  Change in Marijuana Problems Scale (range 0-38; higher scores indicate worse outcome) from baseline through follow-up

  Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up

• Change in Cannabis Use Disorder symptoms from baseline through follow-up

  Change in interviewer-assessed Cannabis Use Disorder criteria (range 0-11; higher scores indicate worse outcome) from baseline to four-month follow-up

  Baseline, Four-Month Follow-up

• Change in Cannabis Demand from baseline to post-intervention

  Change in Omax, Breakpoint, and Elasticity derived from Marijuana Purchase Task (higher OMax/Breakpoint and lower Elasticity indicate worse outcome) at post-intervention compared to baseline

  Baseline, Post-Intervention (20 days after intervention session)

• Change in cannabis use quantity from baseline to post-intervention

  Change in cannabis use quantity (measured via timeline follow-back) from baseline through four-month follow-up

  Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up

Secondary Outcomes (2)

• Change in quality of life from baseline through follow-up

  Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up

• Change in depression and anxiety from baseline through follow-up

  Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up

Study Arms (2)

Emotional Engagement Distress Tolerance Intervention

EXPERIMENTAL

The experimental intervention (single 2.5 hour session) is comprised of video-delivered psychoeducation, adaptive skill practice, and emotional exposure. During exposure, a sequence of percussive sounds accompanied by a visual depiction of the participant's skin conductance level during exposure will be presented at the moment the participant's skin conductance returns to the relaxation baseline value. These images/sound will be intermittently sent to the participant's smart phone during the smart phone portion of the intervention.

Behavioral: Emotional Engagement Distress Tolerance Intervention

Health Education Intervention

PLACEBO COMPARATOR

The health education control intervention is a single 2.5 hour computerized session. It is comprised of audio-narrated videos on healthy habits and self-care in the domains of sleep, nutrition, hygiene, and physical exercise. The same sequence of percussive sounds used in the Emotional Engagement Distress Tolerance Intervention is presented alongside summary slides presenting key points on healthy habits and self-care. These images/sound will be intermittently sent to the participant's smart phone during the smart phone portion of the intervention.

Behavioral: Health Education Intervention

Interventions

Emotional Engagement Distress Tolerance Intervention BEHAVIORAL

2.5 hour computerized intervention with smart phone support focused on building tolerance of emotional distress

Emotional Engagement Distress Tolerance Intervention

Health Education Intervention BEHAVIORAL

2.5 hour computerized intervention with smart phone support focused on building healthy habits that support stress management

Health Education Intervention

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Cannabis is the primary substance of abuse.
• Clinical-level Distress intolerance Index score.
• Current Cannabis Use Disorder diagnosis.
• Near-daily to daily cannabis use in past-month and past 3 months.
• Positive urine screen for THC
• Detectable skin conductance level
• Owns a smart phone
• Primary smoked/vaporized delta-9 or delta-8 THC user

You may not qualify if:

• Presence of acute/major psychiatric disturbance
• Current pregnancy
• Change in psychotropic medication within the past month
• Concurrently receiving treatment for cannabis use
• Concurrently receiving dialectical behavior therapy or exposure-based therapy for emotional disorders
• Planning to immediately quit using cannabis
• EEG contraindications
• Kidney disease

Sponsors & Collaborators

• Florida State University: lead
• Northwestern University: collaborator
• Duke University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The BRAINS Lab at Florida State University

Tallahassee, Florida, 32306-4301, United States

RECRUITING

Study Officials

• Richard J Macatee, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoe Howell Project Coordinator, BS

CONTACT

850-644-2445; brains@psy.fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 16, 2023
• Study Start: June 4, 2024
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)