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dTMS for Smoking Cessation in Schizophrenia
N/A
Recruiting
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 times over 3 weeks
Awards & highlights
Summary
This trial will study how dTMS affects brain chemistry in people with schizophrenia, and how this might help reduce smoking in this vulnerable population. #schizophrenia #smoking #dTMS #PET #brainchemistry
Who is the study for?
This trial is for English-speaking adults aged 18-60 with schizophrenia or related conditions who smoke daily and want to reduce or quit. They must be able to consent, have a negative drug test (except for cannabis), and meet DSM-5 criteria for nicotine use disorder.
What is being tested?
The study tests if deep transcranial magnetic stimulation (dTMS) affects synaptic density in the brain's insula region, measured by PET scans, and if it influences smoking behavior in schizophrenia patients.
What are the potential side effects?
Possible side effects of dTMS may include discomfort at the stimulation site, headache, lightheadedness, seizures (rare), hearing loss if ear protection isn't used during treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 times over 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 times over 3 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Insula synaptic density
Insula-centric functional connectivity
Smoking self-administration
Secondary study objectives
Cigarettes per Day
Nicotine Craving
Symptoms of Psychosis
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active deep transcranial magnetic stimulation (dTMS)Experimental Treatment1 Intervention
Each treatment consists of 60 trains, each lasting 3 sec and interleaved with a 15 sec delay. The entire treatment is delivered over 20 min. The treatment goes for 5 days/week and for a total of 3 weeks.
Group II: ShamPlacebo Group1 Intervention
Active and sham cards do not differ in appearance, and both coils are enclosed within the same helmet, enabling double-blind administration. The same procedure will be done, the only difference is that the sham card does not deliver any stimulation.
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Who is running the clinical trial?
Stony Brook UniversityLead Sponsor
222 Previous Clinical Trials
41,890 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,543 Previous Clinical Trials
3,249,338 Total Patients Enrolled
51 Trials studying Schizophrenia
5,344 Patients Enrolled for Schizophrenia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the information given to me and can make decisions about my health care.I am currently using products to help me stop smoking.I have been diagnosed with a schizophrenia spectrum disorder.I have a history of serious neurological issues or use medication that increases seizure risk.I am between 18 and 60 years old.I am diagnosed with a nicotine addiction and want to reduce or stop smoking.I have been hospitalized within the last 3 months.I have been diagnosed with a schizophrenia spectrum disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Active deep transcranial magnetic stimulation (dTMS)
- Group 2: Sham
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.
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