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Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia

2014-07-24 14:19:57 | BioPortfolio

Summary

The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.

Description

The primary objective of the data analysis will be to measure the rate of smoking cessation in the two treatment groups. Smoking cessation will be measured weekly through a composite measure of self-reported abstinence, end expired carbon monoxide (CO) of less than C10 ppm and urine cotinine dipstick measure of < 30 ng/ml. The primary endpoint will be point prevalence at 12 weeks. The four week continuous abstinence rate for the last four weeks of the treatment phase will also be evaluated. The point prevalence abstinence rates will also be obtained. The secondary objective is to determine whether smoking cessation is associated with a worsening of cognition and psychiatric symptomology. We hypothesize that subjects who achieve abstinence in the varenicline group will not show worsening on neurocognitive and symptom measures compared to abstinence subjects in the placebo group. Lastly, we will attempt to identify any clinical or topographic markers which predict cessation.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Cigarette Smoking

Intervention

varenicline, placebo

Status

Enrolling by invitation

Source

University of Maryland

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:19:57-0400

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Medical and Biotech [MESH] Definitions

The SMOKING of CIGARETTES.

A benzazepine derivative that functions as an ALPHA4/BETA2 NICOTINIC RECEPTOR partial agonist. It is used for SMOKING CESSATION.

Electronic devices that are designed to provide NICOTINE in the form of an inhaled aerosol. They typically are made in the shape of CIGARETTES in order to simulate the experience of CIGARETTE SMOKING.

A decrease in the incidence and frequency of SMOKING. Smoking reduction differs from SMOKING CESSATION in that the smoker continues to smoke albeit at a lesser frequency without quitting.

Pipes for smoking tobacco, cannabis, and other substances, in which smoke is drawn through water. Do not confuse with SMOKING PIPES.

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