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Completed

NCT Number: NCT00736710

rTMS Effects on Smoking Cessation and Cognition in Schizophrenia

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.

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Key information

Conditions

Cigarette Smoking Behavior Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Smoking Tobacco Smoking Tobacco Use

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Procedure

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)

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. P50/NI, N-Back and VSWM Working Memory Performance

    Time frame: intermittent

  2. Expired Breath Carbon Monoxide Levels

    Time frame: intermittent

  3. Tobacco Craving (Tiffany QSU) and Withdrawal (Minnesota NMS)

    Time frame: intemittent

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 18, 2008
Registry last updated
Dec 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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