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Sponsors and Collaborators: |
Centre for Addiction and Mental Health Canadian Psychiatric Research Foundation |
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Information provided by: | Centre for Addiction and Mental Health |
ClinicalTrials.gov Identifier: | NCT00407277 |
Cigarette smoking decreases life expectancy, causes devastating health complications, and costs society billions of dollars each year. These untoward consequences are especially pronounced among persons with schizophrenia (SCZ) because approximately 80% to 95% of this group smokes cigarettes. These high prevalence rates underscore the need for research investigating the determinants of smoking in patients with SCZ. Several researchers have observed that nicotine improves specific symptoms of SCZ including negative symptoms, negative affect, and cognitive deficits. This has led to the hypothesis that patients with SCZ smoke in an attempt to self-medicate. However, the mechanism(s) by which nicotine has its positive effect on symptoms remains unclear. The current proposal posits that neural inhibition (NI) is a physiological mechanism of this effect, while variation in the alpha-7-nicotinic receptor subunit gene (CHRNA7) represents the genetic underpinnings of these processes. The proposed study will assess NI and symptom improvement after acute administration of nicotine to both smokers and nonsmokers with SCZ. In addition, NI and CHRNA7 variation will be tested as predictors of patients' ability to reduce/quit smoking following smoking treatment. These data may lead to the development of new pharmacological strategies for treating the symptoms of SCZ and new methods for assisting these patients to quit smoking.
Condition | Intervention |
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Smoking Nicotine Dependence Schizophrenia Schizophreniform Disorders Schizoaffective Disorder Psychosis |
Drug: Nicotine patch Other: placebo Behavioral: smoking cessation group therapy |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment |
Official Title: | Neural Inhibition as a Mechanism of Nicotine Dependence Among Persons With Schizophrenia |
Estimated Enrollment: | 120 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1A: Experimental |
Drug: Nicotine patch
21 mg of nicotine via a dermal patch
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1B: Placebo Comparator |
Other: placebo
placebo via a dermal patch
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2A: Experimental |
Behavioral: smoking cessation group therapy
a 9-week group based on the "Freedom From Smoking" program designed by the American Lung Association. The treatment was manualized and modified to meet the functional and cognitive capabilities of patients with psychotic disorders
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeff Daskalakis, MD, PhD | 416-535-8501 ext 4319 | jeff_daskalakis@camh.net |
Canada, Ontario | |
Centre for Addiction and Mental Health | Recruiting |
Toronto, Ontario, Canada, M5T 1R8 | |
Contact: Bruce Christensen, PhD 416-535-8501 ext 6843 Bruce_Christensen@camh.net | |
Principal Investigator: Bruce Christensen, PhD | |
Sub-Investigator: Zafiris Daskalakis, MD | |
Sub-Investigator: Robert Zipursky, MD | |
Sub-Investigator: Heather McNeely, PhD | |
Sub-Investigator: Albert Wong, PhD | |
Sub-Investigator: Jean Addington, PhD | |
Sub-Investigator: Peter Selby, MD | |
Sub-Investigator: Rachel Tyndale, PhD |
Principal Investigator: | Jeff Daskalakis, MD,PhD | Centre for Addiction and Mental Health |
Responsible Party: | Centre for Addiction and Mental Health ( Dr. Jeff Daskalakis ) |
Study ID Numbers: | 63/2005 |
Study First Received: | November 30, 2006 |
Last Updated: | March 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00407277 |
Health Authority: | Canada: Health Canada |
nicotine dependence smoking nicotine patch double-blind randomized |
placebo psychosis schizophrenia schizophreniform schizoaffective disorder |
Nicotine polacrilex Schizophrenia Smoking Nicotine Mental Disorders |
Tobacco Use Disorder Substance-Related Disorders Disorders of Environmental Origin Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Disease Cholinergic Agonists Molecular Mechanisms of Pharmacological Action Nicotinic Agonists Physiological Effects of Drugs Central Nervous System Stimulants Cholinergic Agents |
Pharmacologic Actions Habits Pathologic Processes Autonomic Agents Therapeutic Uses Ganglionic Stimulants Peripheral Nervous System Agents Central Nervous System Agents |