RS-tDCS for Cannabis Use Disorder: The C.A.R.E.S. Initiative
ConditionCannabis Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorNYU Langone Health
About this trial
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).
Eligibility criteria
Qualifiers
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])
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Active Transcranial Direct Current Stimulation (tDCS)
- Sham Transcranial Direct Current Stimulation (tDCS)
- Mindfulness meditation
Treatment groups
46 Participants
are divided into 2 treatment groupsSponsors and collaborators
NYU Langone Health
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov