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rTMS Effects on Smoking Cessation and Cognition in Schizophrenia

C

Center for Addiction and Mental Health (CAMH)

Status

Completed

Conditions

Cigarette Smoking
Schizophrenia

Treatments

Procedure: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)
Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study type

Interventional

Funder types

Other

Identifiers

NCT00736710
121/2007

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

15 participants in 2 patient groups

1
Experimental group
Treatment:
Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)
2
Sham Comparator group
Treatment:
Procedure: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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