rTMS Effects on Smoking Cessation and Cognition in Schizophrenia - Full Text View

Sponsored by:	Centre for Addiction and Mental Health
Information provided by:	Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:	NCT00736710

Purpose

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. We predict that active rTMS will be well-tolerated and superior to sham rTMS for enhancing smoking cessation rates in smokers with schizophrenia.

Condition	Intervention
Cigarette Smoking Schizophrenia	Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS) Procedure: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects of rTMS on Smoking Cessation and Cognitive Outcomes in Outpatients With Schizophrenia Treated With Transdermal Nicotine Patch

Resource links provided by NLM:

MedlinePlus related topics: Mental Health Quitting Smoking Schizophrenia Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by Centre for Addiction and Mental Health:

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. [ Time Frame: trial endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

P50/NI, N-Back and VSWM Working Memory Performance [ Time Frame: intermittent ] [ Designated as safety issue: No ]
Expired Breath Carbon Monoxide Levels [ Time Frame: intermittent ] [ Designated as safety issue: No ]
Tobacco Craving (Tiffany QSU) and Withdrawal (Minnesota NMS) [ Time Frame: intemittent ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	December 2008
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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.
2: Sham Comparator	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.

Arms

Assigned Interventions

1: Experimental

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.

2: Sham Comparator

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736710

Contacts

Contact: Tony George, MD

416-535-8501 ext 4544

tony_george@camh.net

Locations

Canada, Ontario
Centre for Addiction and Mental Health	Recruiting
Toronto, Ontario, Canada, M5S 2S1
Principal Investigator: Tony George, MD
Sub-Investigator: Zafiris J Daskalakis, MD, PhD
Sub-Investigator: Eleanor Liu
Sub-Investigator: Gloria Leo

Sponsors and Collaborators

Centre for Addiction and Mental Health

Investigators

Principal Investigator:

Tony George, MD

Centre for Addiction and Mental Health

More Information

Additional Information:

Information about research at the Centre for Addiction and Mental Health This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Centre for Addiction and Mental Health ( Tony George, MD )
Study ID Numbers:	121/2007
Study First Received:	August 15, 2008
Last Updated:	February 18, 2009
ClinicalTrials.gov Identifier:	NCT00736710 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:

Repetitive Transcranial Magnetic Stimulation
Cigarette smoking
Schizophrenia
Randomized

Double-blind
Placebo-controlled
longitudinal
nicotine patch

Study placed in the following topic categories:

Nicotine polacrilex
Schizophrenia
Smoking
Neurotransmitter Agents
Nicotine
Mental Disorders

Nicotinic Agonists
Psychotic Disorders
Peripheral Nervous System Agents
Cholinergic Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Nicotinic Agonists
Physiological Effects of Drugs
Cholinergic Agents
Pharmacologic Actions
Schizophrenia

Smoking
Habits
Mental Disorders
Nicotine
Autonomic Agents
Ganglionic Stimulants
Peripheral Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 11, 2009