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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 times over 3 weeks for reporting.

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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