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NIDA-CSP-1022

Division

DTMC

HEAL Study

Investigator(s)

Elbert D. Glover, PhD, FASHA, FAAHB, FRIPH

Title

Phase 2, Double-Blind, Placebo-Controlled Trial Of Selegiline Transdermal System (STS) As An Aid For Smoking Cessation

Short Description

The objectives of this study are to determine the efficacy and safety of selegiline transdermal system (STS) and brief behavioral intervention for smoking cessation in heavy smokers.

Release Date

May 07, 2018

Description

Determine the efficacy of STS with brief behavioral therapy (the investigational intervention) for smoking cessation in heavy smokers. It is hypothesized that the quit rate at the end of treatment for subjects who receive STS with behavioral intervention will be greater than the quit rate for subjects in the placebo patch control group with behavioral intervention. Determine the safety of the investigational intervention for smoking cessation in heavy smokers as assessed by adverse events, weight gain/loss, vital signs, ECG, and clinical laboratory assessments.

Keywords

Assessments

Exhaled CO-Smoking Level

Hamilton – Depression Rating Scale

Positive and Negative Affect Schedule

Smoking Status - Exhaled CO

Vital Signs Monitoring

Wisconsin Smoking Withdrawal Scale