← Back to Search

Behavioral Intervention

TMS + Counseling + Nicotine Replacement for Smoking Cessation (TMS-STOP Trial)

Phase 2

Recruiting

Led By Jonathan R Young, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-month follow-up

Summary

This trial seeks to evaluate a novel treatment to help Veterans with PTSD quit smoking, combining counseling, nicotine replacement, and brain stimulation. #smokingcessation #PTSD #rTMS

Who is the study for?

This trial is for US Veterans aged 18-75 who smoke at least 10 cigarettes daily, have PTSD, and are stable on psychotropic meds. They must speak English and be willing to try quitting smoking. Excluded are those with brain lesions, recent substance abuse (other than tobacco), heart attack risks, seizure history, certain implanted devices or metals in the head, pregnancy, inability to consent or complete procedures.

What is being tested?

The study tests if combining counseling for smoking cessation with nicotine replacement therapy (like nicotine gum) and repetitive transcranial magnetic stimulation (rTMS)—a noninvasive brain treatment—helps veterans quit smoking more effectively than current methods.

What are the potential side effects?

Possible side effects of rTMS include headache, scalp discomfort at the site of stimulation, lightheadedness; rare risks involve seizures. Nicotine replacement can cause mouth sores, skin irritation from patches and digestive issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-month follow-up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Feasibility as measured by number of participants recruited

Feasibility as measured by the percent of participants who complete the study

Number of participants with self-reported and bioverified abstinence from smoking

Secondary study objectives

Average number of cigarettes smoked per day in past week

Functional network connectivity changes

Neuroimaging correlates to tobacco use

+4 more

Other study objectives

Self-report posttraumatic stress disorder (PTSD) symptoms

Self-reported depressive symptoms

Severity of baseline smoking on abstinence

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: active rTMSExperimental Treatment3 Interventions

Participants assigned to this group will receive active repetitive transcranial magnetic stimulation (rTMS) as part of their smoking cessation treatment.

Group II: sham rTMSPlacebo Group3 Interventions

Participants assigned to this group will receive sham repetitive transcranial magnetic stimulation (rTMS) as part of their smoking cessation treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

nicotine replacement therapy

2009

Completed Phase 4

~2770

Do I qualify?Apply below to find out