Cigarette Smoking, Schizophrenia
Conditions
Keywords
Repetitive Transcranial Magnetic Stimulation, Cigarette smoking, Schizophrenia, Randomized, Double-blind, Placebo-controlled, longitudinal, nicotine patch
Brief 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.
Interventions
PROCEDURERepetitive Transcranial Magnetic Stimulation (rTMS)
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.
Sponsors
Centre for Addiction and Mental Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Canada
Outcome results
None listed