rTMS Effects on Smoking Cessation and Cognition in Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tony George, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT00736710
First received: August 15, 2008
Last updated: December 4, 2012
Last verified: December 2012
  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. 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 Intervention
Cigarette Smoking
Schizophrenia
Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)
Procedure: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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 ]

Enrollment: 15
Study Start Date: December 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
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:
No publications provided

Responsible Party: Tony George, Principal Investigator, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00736710     History of Changes
Other Study ID Numbers: 121/2007
Study First Received: August 15, 2008
Last Updated: December 4, 2012
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

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014