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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) | Procedure | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tony George, MD | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Addiction and Mental Health | Toronto | Ontario | M5S 2S1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29486960 | Derived | Kozak K, Sharif-Razi M, Morozova M, Gaudette EV, Barr MS, Daskalakis ZJ, Blumberger DM, George TP. Effects of short-term, high-frequency repetitive transcranial magnetic stimulation to bilateral dorsolateral prefrontal cortex on smoking behavior and cognition in patients with schizophrenia and non-psychiatric controls. Schizophr Res. 2018 Jul;197:441-443. doi: 10.1016/j.schres.2018.02.015. Epub 2018 Feb 24. |
| Label | URL |
|---|---|
| Information about research at the Centre for Addiction and Mental Health | View source |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D019967 |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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|
| Sham Repetitive Transcranial Magnetic Stimulation (rTMS) | Procedure | 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. |
|
| intemittent |
| Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |