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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
Est. primary completion date
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


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
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