Treating Nicotine Dependence in Schizophrenic Individuals: Effectiveness of Bupropion - 1 - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00124683

Purpose

Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping schizophrenic individuals quit smoking. In addition, this study will evaluate how the combination of bupropion SR and NTP affects psychiatric symptoms and medication side effects.

Condition	Intervention	Phase
Tobacco Use Cessation Tobacco Use Disorder Schizophrenia	Drug: Bupropion Drug: nicotine transdermal patch	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Optimizing Treatment for Schizophrenic Smokers

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Nicotine tartrate Bupropion hydrochloride Bupropion Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

7 day point prevalence of cigarette abstinence [ Time Frame: End of trial (week 10) ]

Secondary Outcome Measures:

Craving [ Time Frame: assessed weekly ]
Medication compliance [ Time Frame: assessed weekly ]
Depression [ Time Frame: assessed at weeks 1, 4, 7, 10 and at six-month followup ]
Withdrawal symptoms [ Time Frame: assessed weekly and at six month followup ]
Schizophrenic symptoms [ Time Frame: assessed at weeks 1, 4, 7, 10 and at six-month followup ]

Enrollment:	59
Study Start Date:	September 2001
Study Completion Date:	May 2007

Arms	Assigned Interventions
Experimental: 1 Nicotine Patch + Bupropion	Drug: Bupropion Drug: nicotine transdermal patch
Placebo Comparator: 2 Nicotine patch + placebo	Drug: nicotine transdermal patch

Detailed Description:

Past research on the use of the NTP, atypical antipsychotics, and bupropion in schizophrenic individuals to aid in smoking cessation has been encouraging. The purpose of this study is to compare bupropion SR to a placebo to determine its effectiveness when used in combination with an NTP to help schizophrenic individuals quit smoking.

Participants in this double-blind, placebo-controlled study will be randomly assigned to receive either the NTP (21 mg/day) and placebo or the NTP and bupropion SR (300 mg/day). Participants will begin taking one pill each day of bupropion SR (150 mg/day) or placebo at the start of the second week of the study. After three days, the dose of bupropion SR or placebo will increase to 2 pills each day. Participants will continue this dosing regimen until the end of Week 10. Throughout the 10-week study, participants will receive weekly group therapy.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

DSM-IV diagnosis of schizophrenia or schizoaffective disorder and nicotine dependence
Fagerstrom Test for Nicotine Dependence (FTND) score greater than 5
Smokes at least 20 cigarettes per day (1 pack per day)
Expired breath CO level > 10 ppm and cotinine level > 210 ng/ml at the baseline measurement
Currently taking a stable dose of antipsychotic
Complete remission from positive symptoms of psychosis as judged by a psychiatric evaluation

Exclusion Criteria:

Meets criteria for current abuse or dependence for any alcohol or illicit substance within the past month
History of hypersensitivity to bupropion or the nicotine transdermal patch (NTP)
Current diagnosis of a serious documented medical disorder that would make bupropion treatment risky OR results of psychiatric/medical screening that suggest a reason for concern (e.g., a history of severe heart, liver, or kidney disease or diabetes mellitus)
Currently taking monoamine oxidase inhibitors or bupropion (Zyban or Wellbutrin)
Currently taking diabetes mellitus medications, St. John's Wort, appetite suppressants, ephedrine-containing medications, theophylline, clonidine, reserpine, methyldopa, or anti-anginal medications (e.g., beta-blockers, calcium channel blockers, nitroglycerin preparations)
History of schizoaffective disorder and not stabilized on a mood stabilizer (e.g., lithium, valproate, carbamazepine)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124683

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Tony P George, M.D.

Yale University

More Information

No publications provided by National Institute on Drug Abuse (NIDA)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

George TP, Vessicchio JC, Sacco KA, Weinberger AH, Dudas MM, Allen TM, Creeden CL, Potenza MN, Feingold A, Jatlow PI. A placebo-controlled trial of bupropion combined with nicotine patch for smoking cessation in schizophrenia. Biol Psychiatry. 2008 Jun 1;63(11):1092-6. Epub 2007 Dec 21.

ClinicalTrials.gov Identifier:	NCT00124683 History of Changes
Other Study ID Numbers:	NIDA-13672-1, R01-13672-1, DPMC
Study First Received:	July 26, 2005
Last Updated:	August 1, 2007
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Tobacco Use Disorder
Schizophrenia
Substance-Related Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Nicotine
Nicotine polacrilex
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists

Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012