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

NCT ID: NCT06085222

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-04
• Study Completion Date: 2027-10-30

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.

Detailed 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 Stage I project aims to modify an existing two-session computerized distress tolerance intervention to optimize emotion regulation learning/generalization 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 and its imaginal exposure module will be modified to shape emotional engagement with the aim of maximizing within-session habituation, which will be signaled with a novel audio/visual cue (habituation cue). Habituation cues will then be delivered in just-in-time text message reminders triggered by naturalistic distress reported via ecological momentary assessment. 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. To measure the intervention's mechanistic target engagement, multi-method distress intolerance assessments will be administered through four-month follow-up. To measure the intervention's impact on cannabis use, stress-related cannabis use motivation (lab stress- elicited craving and neurophysiological drug cue reactivity, ecological momentary assessment of stress-elicited cannabis use) will be assessed through the intervention period. Interviewer-assessed cannabis use frequency, CUD severity, and urinary THC metabolite concentration will be measured through 4-month follow-up. Quality of life and anxiety/depression symptoms will also be measured as secondary outcomes through 4-month follow-up. As an exploratory aim, a wristworn device will be used to measure ambulatory physiology during a portion of the intervention period to evaluate the feasibility of detecting heightened real- world distress based on objective indicators. Our central hypothesis is that, compared to a control intervention, the Emotional Engagement Distress Tolerance Intervention will produce superior reductions in multi-method assessments of distress intolerance, stress-related cannabis use motivation, disordered cannabis use, and psychosocial functioning. Successful completion of the proposed aims will (1) justify a subsequent Stage II trial, and (2) inform efforts to integrate the just-in-time habituation reminders with wearable technology in order to increase emotion regulation generalization opportunities and decrease participant report burden.

Conditions

Cannabis Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Emotional Engagement Distress Tolerance Intervention

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.

Group Type: EXPERIMENTAL

Emotional Engagement Distress Tolerance Intervention

Intervention Type: BEHAVIORAL

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

Health Education Intervention

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.

Group Type: PLACEBO_COMPARATOR

Health Education Intervention

Intervention Type: BEHAVIORAL

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

Interventions

Emotional Engagement Distress Tolerance Intervention

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

Intervention Type: BEHAVIORAL

Health Education Intervention

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Rick James Macatee

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard J Macatee, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

The BRAINS Lab at Florida State University

Tallahassee, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Zoe Howell Project Coordinator, BS

Role: CONTACT

brains@psy.fsu.edu

850-644-2445

Facility Contacts

Zoe Howell Study Coordinator, BS

Role: primary

brains@psy.fsu.edu

850-644-2445

Other Identifiers

1R34DA057733-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00006346

Identifier Type: -

Identifier Source: org_study_id