rTMS Effects on Smoking Cessation and Cognition in Schizophrenia
Condition: Cigarette Smoking; Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Repetitive Transcranial Magnetic Stimulation (rTMS); Sham Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Repetitive Transcranial Magnetic Stimulation; Cigarette smoking; Schizophrenia; Randomized; Double-blind; Placebo-controlled; longitudinal; nicotine patch