rTMS Effects on Smoking Cessation and Cognition in Schizophrenia

Sponsor

Centre for Addiction and Mental Health (Other)

Overall Status

Completed

CT.gov ID

NCT00736710

Collaborator

(none)

Enrollment

Location

Arms

28.9

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cigarette Smoking Schizophrenia	Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS) Procedure: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	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 Comparator: 2	Procedure: 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.

Arm

Intervention/Treatment

Experimental: 1

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 Comparator: 2

Procedure: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.