NCT03856515

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Cigarette Smoking-Related Carcinoma

Interventions

Type	Name	Description
DRUG	Nicotine Replacement	Received NRT (Electronic Cigarette - With Nicotine)
OTHER	Questionnaire Administration	Ancillary studies
DEVICE	Electronic Cigarette	Electronic Cigarette - with Nicotine
DEVICE	Electronic Cigarette	Electronic Cigarette -without Nicotine

Timeline

• Start date: 2022-06-02
• Primary completion: 2024-06-24
• Completion: 2026-01-07
• First posted: 2019-02-27
• Last updated: 2026-01-28
• Results posted: 2025-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study