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Behavioural Intervention
TMS for Smoking Cessation in Schizophrenia
Verified Trial
N/A
Recruiting
Led By Xiaoming Du, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
You have been diagnosed with Schizophrenia
You have been diagnosed with Nicotine Addiction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
Study Summary
This trial is testing whether transcranial magnetic stimulation can help people with schizophrenia quit smoking.
Who is the study for?
This trial is for adults aged 18-60 who smoke at least 5 cigarettes daily for the past year, have schizophrenia spectrum disorder, and can consent to participate. Excluded are those with certain metal implants, severe head injuries, pregnancy or unprotected sex without birth control recently, active suicidal thoughts or behaviors, recent substance abuse (except nicotine/marijuana), specific medication dosages or medical conditions affecting brain function.Check my eligibility
What is being tested?
The study tests two types of rTMS treatments using F8-coil and H-coil on patients with schizophrenia for smoking cessation. It measures changes in smoking behavior and brain connectivity before treatment, during different stages of rTMS therapy, and at follow-up sessions.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of rTMS may include headache, scalp discomfort at the site of stimulation, tingling or spasms of facial muscles.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cigarette per day
Resting-state functional connectivity (rsFC) from functional magnetic resonance imaging (fMRI)
Secondary outcome measures
End-expired carbon monoxide (CO)
Fagerstrom Test for Nicotine Dependence (FTND)
nicotine/creatinine
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Study groupExperimental Treatment1 Intervention
Participants in this group will receive active F8-coil delivered rTMS.
Group II: Active control groupActive Control1 Intervention
Participants in this group will receive active H-coil delivered rTMS.
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,927 Total Patients Enrolled
4 Trials studying Schizophrenia
255 Patients Enrolled for Schizophrenia
University of Maryland, BaltimoreLead Sponsor
687 Previous Clinical Trials
374,596 Total Patients Enrolled
66 Trials studying Schizophrenia
10,207 Patients Enrolled for Schizophrenia
Xiaoming Du, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
2 Previous Clinical Trials
180 Total Patients Enrolled
2 Trials studying Schizophrenia
180 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that increases my risk of seizures.I am between 22 and 65 years old.I have had a head injury with unconsciousness for over 10 minutes or brain surgery.I am currently seeing a doctor or mental health professional.I have a close family member with inherited epilepsy or seizures.I have tried to quit smoking in the last four weeks.I have a cardiac pacemaker, medication pump, intracardiac lines, or unstable heart condition.I take more than 400 mg of clozapine daily or I did not pass the TMS screening.I am not pregnant and have used birth control consistently for the last 4 weeks.I do not have any major illnesses that affect my brain's functioning.I am between 18 and 60 years old.You have smoked within the past year and have been smoking an average of 5 or more cigarettes per day in the past 4 weeks.You have smoked cigarettes regularly within the past year, and you smoke at least 5 cigarettes a day in the last 4 weeks.You are diagnosed with schizophrenia-spectrum disorder and you are over the age of 18.
Research Study Groups:
This trial has the following groups:- Group 1: Study group
- Group 2: Active control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Schizophrenia Patient Testimony for trial: Trial Name: NCT05276050 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible to partake in this experiment?
"This medical trial is recruiting 50 individuals with schizophrenia, aged 18 to 60. Those who apply need to fulfil the following prerequisites: gender-neutrality, capacity for written consent, smoking over a year or more at 5 cigarettes per day in the last 4 weeks, clinically diagnosed schizoprenia-spectrum disorder and an Evaluation to Sign Consent score above 10."
Answered by AI
To what extent can this research be conducted with participants?
"Affirmative. Clinicaltrials.gov attests that this trial is actively recruiting; the details of which were initially posted on June 1st 2022, and updated most recently on November 15th 2022. The study calls for 50 individuals to be recruited at one medical centre."
Answered by AI
Are participants aged 50 and over accepted for this research endeavor?
"The age requirement to be eligible for this medical trial is between 18 and 60 years old."
Answered by AI
Are participants still being accepted for this research endeavor?
"Indeed, clinicaltrials.gov verifies that this medical trial is actively recruiting patients since it was first published on June 1st 2022 and updated most recently in November 15th 2022. The research necessitates the recruitment of 50 individuals from a single site."
Answered by AI
Who else is applying?
What state do they live in?
California
Nevada
New Jersey
How old are they?
18 - 65
What site did they apply to?
University of Maryland, Baltimore
The University of Texas Health Science Center, Houston
University of Texas, Houston
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
Why did patients apply to this trial?
I need to quit smoking. Been trying different Meds. To see the actual meaning of schizophrenia.
PatientReceived no prior treatments
Recently I've gotten worse for an unknown rea. i've tried to quit and i am hoping you can help.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How much does it pay? What is the best way for me to ensure I get the most accurate and usable results for this, and other trials?
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Most responsive sites:
- University of Texas, Houston: < 24 hours
- University of Maryland, Baltimore: < 48 hours
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