RS-tDCS for Cannabis Use Disorder: The C.A.R.E.S. Initiative (NCT07184983) | Clinical Trial Compass
RecruitingNot Applicable
RS-tDCS for Cannabis Use Disorder: The C.A.R.E.S. Initiative
United States46 participantsStarted 2025-11-12
Plain-language summary
The purpose of this sham-controlled pilot randomized controlled trial (RCT) is to evaluate the feasibility, safety, and preliminary efficacy of a one-month intervention consisting of 20 home-based active or sham RS-tDCS sessions paired with audio track guided mindfulness meditation practice in otherwise healthy adults seeking to reduce cannabis use in the context of cannabis use disorder (CUD).
Who can participate
Age range22 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged 22-65 years (inclusive)
✓. Currently meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for CUD, as determined by DSM-V criteria (M.I.N.I)
✓. Positive for cannabis on the 11-COOH-THC single panel urine test
✓. Seeking treatment to reduce or discontinue cannabis use (Marijuana Ladder ranged between 5-8 \[inclusive\])
✓. Wide Range Achievement Test-5(WRAT-5) score ≥ 85
✓. Ability to use mobile devices
✓. Fluent in English or Spanish
Exclusion criteria
✕. Cannabis is used exclusively as prescribed or directed by their provider
✕. Meets DSM-V criteria for substance use disorder within the past six months for any psychoactive substance other than cannabis
✕. Meets DSM-V criteria for alcohol use disorder within the past six months
✕. Primary psychiatric disorder (major depressive disorder, bipolar disorder, or psychotic disorder) as the principal diagnosis, independent of cannabis use disorder; or current diagnosis of bipolar disorder, psychotic disorder, or any other alcohol/substance use disorder as defined by DSM-5-TR and confirmed via the Mini-International Neuropsychiatric Interview (MINI).
What they're measuring
1
The proportion of participants who complete at least 70% (14 out of 20) of intervention sessions
Timeframe: End of treatment (up to 6 weeks)
2
The proportion of participants who discontinue due to adverse effects
Timeframe: End of treatment (up to 6 weeks)
3
The proportion of participants with no serious adverse events
Timeframe: End of treatment (up to 6 weeks)
4
Change in cannabis use frequency, measured by the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU)
Timeframe: Baseline, End of treatment (up to 6 weeks)
5
Change in daily cannabis use, measured by the Timeline Followback (TLFB) method assessment
Timeframe: Baseline, End of treatment (up to 6 weeks)
6
Change in cannabis withdrawal symptoms, measured by the Cannabis Withdrawal Scale (CWS)
Timeframe: Baseline, End of treatment (up to 6 weeks)