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Behavioural Intervention

Active Bilateral 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

CDiA-P4 Trial 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.

CDiA-P4 Trial 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.

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

CDiA-P4 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor

356 Previous Clinical Trials

81,418 Total Patients Enrolled

16 Trials studying Alcoholism

3,465 Patients Enrolled for Alcoholism

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to participate in this clinical investigation?

"Participants with alcohol use disorder aged between 18 and 59 are eligible for enrollment in this study, which aims to recruit a total of 40 individuals."

Answered by AI

Are individuals currently able to apply and participate in this ongoing research study?

"According to clinicaltrials.gov, this investigation is actively seeking participants. The original posting date for this trial was 2/7/2022 and the most recent revision was made on 3/1/2024."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical research study?

"Indeed, the details on clinicaltrials.gov confirm that recruitment is ongoing for this particular trial. The study was initially listed on February 7th, 2022 and underwent its most recent update on March 1st, 2024. To meet its objectives, the trial aims to enroll a total of 40 patients at one designated site."

Answered by AI

Are individuals aged 70 and above being recruited for this research study?

"To be eligible for this study, individuals aged between 18 and 59 are sought. Notably, there is a pool of 262 trials tailored for minors under the age of 18 and another set of 1286 trials designated for elderly patients over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cognitive Dysfunction in the Addictions Study - Project 4 (P4)

2022. "Cognitive Dysfunction in the Addictions Study - Project 4 (P4)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06299787.

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