The effect of high-frequency rTMS on alcohol craving – Results from a double-blinded randomized sham-controlled trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Department of Psychiatry
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Reduction in alcohol craving
Study Overview
Brief Summary
High-frequency rTMS will be applied over the right prefrontal cortex (rPFC). Alcohol craving measured using the Alcohol Craving Questionnaire (ACQ)****-SF-R, tolerability and feasibility of administering rTMS and Alcohol use patterns, including abstinence duration, and relapse episodes via Time Line Follow Back method- alcohol (TLFB- Alcohol) will be assessed across five timepoints: baseline, post-treatment, one-month, three-month and six-month follow-up, compared to sham rTMS.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adults more than or equal to 18 years with ICD 11 diagnosis of Alcohol Dependence.
- •Patients not in active withdrawal that is, CIWA-Ar less than or equal to 10 at enrollment.
- •Right-handed and willing to stay for 10-day intervention.
- •Provided written informed consent.
Exclusion Criteria
- •History of seizures, epilepsy, or neurological conditions.
- •Implanted metal devices or medications lowering seizure threshold.
- •Severe psychiatric comorbidity like schizophrenia, BPAD etc,.
- •Pregnancy, lactation, or concurrent substance dependence.
Outcomes
Primary Outcomes
Reduction in alcohol craving
Time Frame: alcohol craving, measured using the Alcohol Craving Questionnaire (ACQ)-SF-R, across five timepoints: baseline, post-treatment, one-month, three-month and six-month follow-up, compared to sham rTMS.
Secondary Outcomes
- tolerability and feasibility of administering rTMS, alcohol use pattern post-intervention.(baseline, post-treatment, one-month, three-month and six-month follow-up)
Investigators
Dr Vijeyta N
Government Stanley medical college and hospital