rTMS Effects on Smoking Cessation and Cognition in Schizophrenia

Study Overview
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Brief Summary
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Patients with schizophrenia have high rates of cigarette smoking and tobacco dependence, and great difficulties in quitting smoking. The development of novel and more effective treatments for tobacco dependence in this population is thus needed. This study will test the hypothesis that repetitive transcranial magnetic stimulation (rTMS) may facilitate smoking cessation with the transdermal nicotine patch (TNP) in patients with schizophrenia motivated to quit smoking. A total of N=40 smokers with schizophrenia would be assigned to either active rTMS (N=20) or sham rTMS (N=20) as a treatment regimen of 5X/week treatments for four weeks. All subjects would receive TNP (21 mg/24h) and weekly group behavioral therapy for smoking cessation for a total of 10 weeks. The investigators predict that active rTMS will be well-tolerated and superior to sham rTMS for enhancing smoking cessation rates in smokers with schizophrenia.

Official Title
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Effects of rTMS on Smoking Cessation and Cognitive Outcomes in Outpatients With Schizophrenia Treated With Transdermal Nicotine Patch

Conditions
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Cigarette Smoking, Schizophrenia

Intervention / Treatment
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* Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)
* Procedure: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-IV diagnosis of schizophrenia or schizoaffective disorder Smoking at least 10 cigarettes per day and a Fagerstrom score of at least 4. Willing to quit smoking in the next 30 days. Exclusion Criteria: Active alcohol or illicit drug abuse or dependence in the past 3 months A history of seizures, head trauma or space occupying lesions. A history of alcohol or illicit drug abuse in the past 6 months. Intolerance of the nicotine patch or its excipients Evidence for psychiatric instability as judged by acute psychotic exacerbations, suicidal or homicidal ideation. Females who are pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)<br>* The rTMS procedures will be delivered in a single-blind fashion by the rTMS technician at the CAMH rTMS Laboratory. All subjects would be enrolled in a 10-week smoking cessation program using weekly group behavioral therapy which will emphasize psychoeducation about the effects of smoking on psychiatric and medical aspects of schizophrenia, social skills training, relapse-prevention skills training and benefits of quitting smoking. All subjects would start group therapy interventions in Week 1 of the trial, and begin rTMS procedures in a separate session on Week 2. The transdermal nicotine patch (TNP; 21 mg/24h) would be applied during the quit date at Week 3 (Day 15). At the end of the 10-week trial, TNP and group therapy would be discontinued.<br>|
| Sham Comparator: 2<br> | Procedure: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)<br>* The rTMS procedures will be delivered in a single-blind fashion by the rTMS technician at the CAMH rTMS Laboratory. All subjects would be enrolled in a 10-week smoking cessation program using weekly group behavioral therapy which will emphasize psychoeducation about the effects of smoking on psychiatric and medical aspects of schizophrenia, social skills training, relapse-prevention skills training and benefits of quitting smoking. All subjects would start group therapy interventions in Week 1 of the trial, and begin rTMS procedures in a separate session on Week 2. The transdermal nicotine patch (TNP; 21 mg/24h) would be applied during the quit date at Week 3 (Day 15). At the end of the 10-week trial, TNP and group therapy would be discontinued.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking abstinence (7-day point prevalence) at trial endpoint (Days 63-70) as assessed by self-reported smoking abstinence plus Expired Breath Carbon Monoxide Level <10ppm. |  | trial endpoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P50/NI, N-Back and VSWM Working Memory Performance |  | intermittent | 
| Expired Breath Carbon Monoxide Levels |  | intermittent | 
| Tobacco Craving (Tiffany QSU) and Withdrawal (Minnesota NMS) |  | intemittent | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Repetitive Transcranial Magnetic Stimulation, Cigarette smoking, Schizophrenia, Randomized, Double-blind, Placebo-controlled, longitudinal, nicotine patch