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

Schizophrenia Clinical Trial

Official title:

Optimizing Treatment for Schizophrenic Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00124683
• Other study ID #: NIDA-13672-1
• Secondary ID: R01-13672-1DPMC
• Status: Completed
• Phase: Phase 2
• First received: July 26, 2005
• Last updated: January 11, 2017
• Start date: September 2001
• Est. completion date: May 2007

Study information

• Verified date: August 2007
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia
• Tobacco Use Cessation
• Tobacco Use Disorder

Intervention

Drug:
• Bupropion

• nicotine transdermal patch

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7 day point prevalence of cigarette abstinence		End of trial (week 10)
Secondary	Craving		assessed weekly
Secondary	Medication compliance		assessed weekly
Secondary	Depression		assessed at weeks 1, 4, 7, 10 and at six-month followup
Secondary	Withdrawal symptoms		assessed weekly and at six month followup
Secondary	Schizophrenic symptoms		assessed at weeks 1, 4, 7, 10 and at six-month followup