Treating Nicotine Dependence in Schizophrenic Individuals: Effectiveness of Bupropion - 1
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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 2 |
| 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 |
- 7 day point prevalence of cigarette abstinence [ Time Frame: End of trial (week 10) ]
- 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 |
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 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):
| 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 May 23, 2013