Theta Burst Stimulation for Alcoholism (CDiA-P4 Trial)

N/A

Recruiting

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 4 weeks after baseline (after 20 treatments of active/sham rtms)

Summary

This trial aims to investigate a new treatment approach for alcohol use disorder (AUD) that also targets depressive symptoms. The study will use theta burst stimulation (TBS) as a form of transcranial

Who is the study for?

This trial is for adults aged 18-59 with alcohol use disorder (AUD) and major depressive disorder (MDD), without psychotic symptoms. Participants must be able to consent, adhere to the study schedule, maintain current medications constant, and not have used problematic substances other than nicotine or caffeine in the last month. Exclusions include dementia, significant medical or neurological disorders, non-English speakers, pregnancy intention during the study period, ECT failure history, metal implants near head or specific medication that affects rTMS efficacy.

What is being tested?

The trial tests intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation targeting the prefrontal cortex to treat AUD with coexisting depressive symptoms. It compares iTBS against sham stimulation—a placebo-like treatment—to evaluate its effectiveness on cognitive functions disrupted by both conditions.

What are the potential side effects?

While side effects are not explicitly listed here, typical ones associated with rTMS may include headache, scalp discomfort at the site of stimulation, lightheadedness and rare risk of seizure; however individual experiences can vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 4 weeks after baseline (after 20 treatments of active/sham rtms)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 4 weeks after baseline (after 20 treatments of active/sham rtms)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 4 weeks after baseline (after 20 treatments of active/sham rtms) for reporting.