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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Active Transcranial Direct Current Stimulation (tDCS)
DevicetDCS is a noninvasive brain stimulation device that modulates brain activity by delivering low-intensity electrical current (2.0 mA) through scalp sponge electrodes. Device is programmed to ramp up to 2.0 mA (for 30 seconds), provide constant current throughout the session (19 minutes), and then ramp down (for 30 seconds) at the end.
Sham Transcranial Direct Current Stimulation (tDCS)
DevicetDCS is a noninvasive brain stimulation device that modulates brain activity by delivering low-intensity electrical current (2.0 mA) through scalp sponge electrodes. Device is programmed to ramp up to 2.0 mA (for 30 seconds) followed by a ramp down (30 seconds), with no current delivery for 18 minutes, and then ramp up (for 30 seconds) and down (for 30 seconds) at the end.
Mindfulness meditation
BehavioralParticipants will follow an audio track for guided mindfulness during the stimulation.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Active tDCSExperimental treatment 2 interventions
Group B: Sham tDCSActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
The proportion of participants who complete at least 70% (14 out of 20) of intervention sessions
Time frame
End of treatment (up to 6 weeks)2
The proportion of participants who discontinue due to adverse effects
Time frame
End of treatment (up to 6 weeks)3
The proportion of participants with no serious adverse events
Time frame
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)
The DFAQ-CU is a self-report scale used to assess cannabis use behaviors. It measures frequency, quantity, age of onset, and daily sessions of cannabis use, including different forms like dry product, concentrates, and edibles. The DFAQ-CU also includes visual aids and questions about methods of cannabis administration and tetrahydrocannabinol (THC) levels. Questions 2-3, 6-12 assess frequency.
Time frame
Baseline, End of treatment (up to 6 weeks)Secondary outcomes
1
Change in cannabis craving, measured by the Marijuana Craving Questionnaire (MCQ-17)
Time frame
Baseline, 1-month follow-up2
Change in psychological distress as measured by the Kessler Psychological Distress Scale (K10)
K10 is a 10-item questionnaire intended to yield a global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. Each question is given a score between 1 (none of the time) to 5 (all of the time). The total score ranges from 10 to 50. People with scores \< 20 are likely to be well, 20-24 are likely to have a mild mental disorder, 25-29 are likely to have moderate mental disorder, and \> 30 are likely to have a severe mental disorder.
Time frame
Baseline, 1-month follow-up3
Change in anxiety as measured by State-Trait Anxiety Inventory (STAI)
The STAI is a psychological tool used to measure both state anxiety (temporary feelings of nervousness) and trait anxiety (a general tendency to be anxious). It's a 40-item self-report questionnaire, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales, that uses a 4-point Likert scale. Item scores are added to obtain subtest total scores. Scoring should be reversed for anxiety-absent items (19 items of the total 40). Range of scores for each subtest is 20-80, the higher score indicating greater anxiety.
Time frame
Baseline, 1-month follow-up4
Change in function as measured by the Marijuana Problem Scale (MPS)
The MPS (form AS5) is a self-report assessment that helps the patient identify areas their life affected by marijuana use. It contains 19 items that represent potential negative effects of marijuana on social relationships, self-esteem, motivation and productivity, work and finances, physical health, memory impairment, and legal problems. Items are rated either 0 (Not a problem), 1 (A minor problem), or 2 (A serious problem). Higher scores generally indicate more serious problems with marijuana.
Time frame
Baseline, 1-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov