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Gender Differences in Switching From Smoking Regular Cigarettes to E-Cigarettes

Cigarette Smoking-Related Carcinoma Clinical Trial

Official title:
Gender Differences in Standardized Research E-Cigarette (SREC) Product Use, Acceptability, Reinforcement, and Nicotine Dependence Symptoms

Clinical Trial Summary

This early phase I trial studies potential differences between men and women when switching from the use of combustible cigarettes to the National Institute on Drug Abuse's Standard Research E-Cigarette (SREC). Studying the differences between men and women may increase understanding about the effects of switching from smoking regular cigarettes to electronic cigarettes.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To characterize the effects of switching to nicotine versus (vs.) placebo standard research E-cigarettes (SRECs) from combustible cigarettes (CCs) on product use, product acceptability, reinforcement, and nicotine dependence symptoms among adult daily CC smokers. II. To characterize the differences between male and female CC smokers when switching to nicotine versus (vs.) placebo SRECs from CCs on product use, product acceptability, reinforcement, and nicotine dependence symptoms. EXPLORATORY OBJECTIVE: I. To characterize which factors moderate or mediate the effects of switching to nicotine and placebo SRECs from CCs among male and female CC smokers. OUTLINE: Participants will be instructed to smoke their usual brand cigarette as they normally would in weeks 1-2 (Phase I) and to use only the SREC (with or without nicotine) in weeks 3-4 (Phase II) and in weeks 5-6 (Phase III). Participant assignment to SREC type at Phases II and III will be counter-balanced within group, with half of men and women receiving the placebo SREC during Phase II and half during Phase III. Participants will attend 4 laboratory visits with study investigators for 3 hours each over 6 weeks of study participation. ;

Study Design

Related Conditions & MeSH terms

  • Cigarette Smoking-Related Carcinoma
Clinical Trial Details
NCT number NCT03856515
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Jason Robinson
Phone 713-792-2265
Email nicotinestudy@mdanderson.org
Status Recruiting
Phase N/A
Start date June 2, 2022
Completion date August 31, 2025
View Details
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