rTMS Effects on Smoking Cessation and Cognition in Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736710
• Other study ID #: 121/2007
• Status: Completed
• Phase: N/A
• First received: August 15, 2008
• Last updated: December 4, 2012
• Start date: December 2008
• Est. completion date: May 2011

Study information

• Verified date: December 2012
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cigarette Smoking
• Schizophrenia

Intervention

Procedure:
• Repetitive 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.
• Sham Repetitive 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.

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	P50/NI, N-Back and VSWM Working Memory Performance		intermittent	No
Secondary	Expired Breath Carbon Monoxide Levels		intermittent	No
Secondary	Tobacco Craving (Tiffany QSU) and Withdrawal (Minnesota NMS)		intemittent	No

External Links

•   Information about research at the Centre for Addiction and Mental Health