RS-tDCS for Cannabis Use Disorder: The C.A.R.E.S. Initiative

Official title

Telehealth-Delivered tDCS for Cannabis Addiction Recovery: The C.A.R.E.S. (Cannabis Addiction Recovery Enhancement Stimulation) Initiative

Overview

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).

Interventions

• Device Active Transcranial Direct Current Stimulation (tDCS)
  tDCS 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.
• Device Sham Transcranial Direct Current Stimulation (tDCS)
  tDCS 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.
• Behavioral Mindfulness meditation
  Participants will follow an audio track for guided mindfulness during the stimulation.

Primary outcome measures

• 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)]
• The proportion of participants who discontinue due to adverse effects [Time frame: End of treatment (up to 6 weeks)]
• The proportion of participants with no serious adverse events [Time frame: End of treatment (up to 6 weeks)]
• Change in cannabis use frequency, measured by the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU) [Time frame: Baseline, End of treatment (up to 6 weeks)]
• Change in daily cannabis use, measured by the Timeline Followback (TLFB) method assessment [Time frame: Baseline, End of treatment (up to 6 weeks)]
• Change in cannabis withdrawal symptoms, measured by the Cannabis Withdrawal Scale (CWS) [Time frame: Baseline, End of treatment (up to 6 weeks)]

Secondary outcome measures (8)

• Change in cannabis craving, measured by the Marijuana Craving Questionnaire (MCQ-17) [Time frame: Baseline, 1-month follow-up]
• Change in psychological distress as measured by the Kessler Psychological Distress Scale (K10) [Time frame: Baseline, 1-month follow-up]
• Change in anxiety as measured by State-Trait Anxiety Inventory (STAI) [Time frame: Baseline, 1-month follow-up]
• Change in function as measured by the Marijuana Problem Scale (MPS) [Time frame: Baseline, 1-month follow-up]
• Change in depression as measured by the Beck Depression Inventory (BDI) [Time frame: Baseline, 1-month follow-up]
• Change in cannabis use frequency, measured by the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU) [Time frame: Baseline, 1-month follow-up]
• Change in daily cannabis use, measured by the Timeline Followback Method Assessment (TLFB) [Time frame: Baseline, 1-month follow-up]
• Change in cannabis withdrawal symptoms, measured by the Cannabis Withdrawal Scale (CWS) [Time frame: Baseline, 1-month follow-up]

Eligibility criteria

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 \[inclusive\])
• Kessler Psychological Distress Scale (K10) score < 35 (minimal to moderate distress)
• 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).
• Primary neurologic or major medical disorder that would interfere with study participation.
• Enrolled in group or individual therapy for substance use disorder that would be concurrent with the study intervention
• History of moderate or severe traumatic brain injury
• Seizure disorder or recent (<5 years) seizure history
• Presence of metal or active implants in the head/neck
• Any skin disorder or skin sensitive area near stimulation locations
• Pregnant or planning pregnancy during the study period or breastfeeding

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• NYU Langone Health — New York

Identifiers

NCT: NCT07184983 · 25-00489 · 1UG3DA063344-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗