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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
Awards & highlights
TMS-STOP Trial 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.Check my eligibility
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.See study design
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.
TMS-STOP Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Average number of cigarettes smoked per day in past week
Functional network connectivity changes
Neuroimaging correlates to tobacco use
+4 moreOther outcome measures
Self-report posttraumatic stress disorder (PTSD) symptoms
Self-reported depressive symptoms
Severity of baseline smoking on abstinence
TMS-STOP 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
1,611 Previous Clinical Trials
3,305,234 Total Patients Enrolled
15 Trials studying Tobacco Use Disorder
2,928 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an age restriction on participants for this clinical trial?
"This clinical trial is enrolling adults aged between 18 and 75."
Answered by AI
Is repetitive transcranial magnetic stimulation considered a secure form of therapy?
"Although there is some evidence for its safety, the lack of data confirming efficacy leads to an estimated score of 2 on a scale between 1 and 3."
Answered by AI
To whom is enrollment in the clinical trial open?
"Only those individuals who suffer from tobacco use disorder and are situated between 18 to 75 can be accepted into this clinical trial. The research is in need of a total of 50 participants."
Answered by AI
Is there still an opportunity for individuals to take part in this trial?
"As per clinicaltrials.gov, this research is no longer recruiting participants; it was originally posted on July 1st 2023 and last updated February 1st 2023. Nevertheless, there are 106 other studies currently enrolling volunteer patients."
Answered by AI
What are the anticipated outcomes of this medical experiment?
"The primary outcome of this clinical trial, which is to be monitored from the time of consent, focuses on feasability as indicated by completion rates. Secondary outcomes encompass Minnesota Nicotine Withdrawal Scale scores (ranging 0-36), Questionnaire of Smoking Urges ratings (0-60), and relapse markers denoting 5 or more cigarettes smoked per day for 3 consecutive days."
Answered by AI
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