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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
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 moreOther 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
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,665 Previous Clinical Trials
3,765,727 Total Patients Enrolled
16 Trials studying Tobacco Use Disorder
2,885 Patients Enrolled for Tobacco Use Disorder
Jonathan R Young, MDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 75 years old.I or someone in my family has had seizures or epilepsy.I have a history of brain conditions that could increase my risk of seizures.I have undergone rTMS treatment before.I have had brain surgery or have a brain lesion.I had a heart attack in the last 6 months or can't use nicotine replacement therapy.I am currently taking bupropion or varenicline.I am willing to try to quit smoking.I have been diagnosed with PTSD.I have been on the same mental health medication for over three months.I cannot follow the study's required procedures.
Research Study Groups:
This trial has the following groups:- Group 1: sham rTMS
- Group 2: active rTMS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.