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Behavioural Intervention

Transcranial Magnetic Stimulation for Smoking Addiction

N/A

Recruiting

Led By Travis E Baker, PhD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

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

Must have

Be between the ages of 18 and 55 years old

Be between 18 and 65 years old

Must not have

History of autoimmune, endocrine, viral, or vascular disorder affecting the brain

History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 (day of testing)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find the best way to use brain stimulation to help smokers by testing different protocols. They will also assess how these protocols affect decision-making and cravings. The study will involve two sessions and

Who is the study for?

This trial is for individuals who are struggling with tobacco use disorder or smoking addiction. Participants should be dependent smokers to qualify.

What is being tested?

The study aims to find the best Transcranial Magnetic Stimulation (TMS) pulse protocol that can influence reward activity in the brain, potentially helping with decision-making and reducing cravings in smokers.

What are the potential side effects?

While not explicitly stated, TMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in rare cases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of disorders like autoimmune or viral that affect the brain.

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I have a neurological disorder that affects my brain or physical abilities.

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I have never been diagnosed with bipolar disorder, schizophrenia, PTSD, dementia, or major depression.

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I am on constant medication for my brain or nerves.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 (day of testing)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 (day of testing)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 (day of testing) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-related Brain Potential: Reward Positivity

Secondary study objectives

Approach Learning

Other study objectives

Nicotine Craving

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Inhibitory TMSExperimental Treatment1 Intervention

For condition 1b, 600 or 1200 pulses of iTBS. iTBS will be administered at 80% of each participant's RMT in a burst-firing pattern (3 pulses at 50 Hz) for a 2 s train, followed by an 8 s period of rest. Across sessions, participants will receive one of two iTBS protocols (randomized): 600 pulses (190 s) or 1200 pulses (570 s).

Group II: Excitatory TMSExperimental Treatment1 Intervention

For condition 1a, 3600 pulses of 10-Hz TMS or 3600 pulses of cTBS. 10 Hz rTMS (110% RMT stimulation intensity; 10 Hz frequency; 5 s on and 26 s off; 3600 pulses per session; total duration of 40 min). cTBS (80% RMT, (3 pulses at 50 Hz with a repeated frequency of 5 Hz, 200 ms intervals, containing 1800 pulses, 60 second break, 1800 pulses; total duration of 5 minutes).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Magnetic Stimulation

2017

Completed Phase 4

~730

0 / 5Eligibility criteria met