rTMS Effects on Smoking Cessation and Cognition in Schizophrenia

Not Applicable

Completed

• Conditions: Schizophrenia; Cigarette Smoking
• Interventions: Procedure: Sham Repetitive Transcranial Magnetic Stimulation (rTMS); Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)

• Registration Number: NCT00736710
• Lead Sponsor: Centre for Addiction and Mental Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-15
• Study First Submitted QC: 2008-08-15
• Study First Posted: 2008-08-18
• Study Start: 2008-12
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-04
• Last Update Posted: 2012-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Sham Repetitive Transcranial Magnetic Stimulation (rTMS)	-
1	Repetitive Transcranial Magnetic Stimulation (rTMS)	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada