Clinical trial NCT06085222: Evaluation of a Brief Computerized and Smart Phone-based Intervention for Stress in Regular Cannabis Users
Official title: Refinement and Testing of a Brief Computerized and Smart Phone-based Intervention for Stress in Regular Cannabis Users
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cannabis Use Disorder
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: Duke University
name: National Institute on Drug Abuse (NIDA)
First posted: 2023-10-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Therapy Evaluation Questionnaire
timeFrame: Immediately after intervention session
measure: Treatment Satisfaction Questionnaire
timeFrame: Post-Intervention (20 days after intervention session)
measure: Change in perceived distress intolerance from baseline through follow-up
timeFrame: Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
measure: Change in behavioral distress intolerance from baseline through follow-up
timeFrame: Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
measure: Change in laboratory stress-induced cannabis craving from baseline through post-intervention
timeFrame: Baseline, Post-Intervention (20 days after intervention session)
measure: Change in laboratory stress-induced neural reactivity to cannabis cues (assessed via the electroencephalography [EEG]-recorded late positive potential) from baseline through post-intervention
timeFrame: Baseline, Post-Intervention (20 days after intervention session)
measure: Change in real-world stress-elicited cannabis use from baseline to post-intervention
timeFrame: Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session)
measure: Change in cannabis use frequency from baseline through follow-up
timeFrame: Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
measure: Change in urine tetrahydrocannabinol [THC] metabolite concentration from baseline through follow-up
timeFrame: Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
measure: Change in self-reported cannabis use problems from baseline through follow-up
timeFrame: Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
measure: Change in Cannabis Use Disorder symptoms from baseline through follow-up
timeFrame: Baseline, Four-Month Follow-up
measure: Change in Cannabis Demand from baseline to post-intervention
timeFrame: Baseline, Post-Intervention (20 days after intervention session)
measure: Change in cannabis use quantity from baseline to post-intervention
timeFrame: Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
Secondary outcomes:
measure: Change in quality of life from baseline through follow-up
timeFrame: Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
measure: Change in depression and anxiety from baseline through follow-up
timeFrame: Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
Study officials:
affiliation: Auburn University
name: Richard J Macatee, PhD
role: PRINCIPAL_INVESTIGATOR
References: