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Behavioural Intervention

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)
Awards & highlights

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.Check my eligibility
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.See study design
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 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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Executive Function Index - inhibition
Executive Function Index - set shifting
Executive Function Index - working memory
Secondary outcome measures
17-Item Hamilton Depression Rating Scale (HRSD-17)
Other outcome measures
Columbia-Suicide Severity Rating Scale

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active BilateralActive Control1 Intervention
Bilteral TBS, applied as cTBS over the right DLPFC followed by iTBS over the left DLPFC
Group II: ShamPlacebo Group1 Intervention
Sham TBS

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
359 Previous Clinical Trials
81,519 Total Patients Enrolled
17 Trials studying Alcoholism
3,495 Patients Enrolled for Alcoholism
~6 spots leftby Dec 2024