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

Not Applicable

Active, not recruiting

• Conditions: Cigarette Smoking-Related Carcinoma
• Interventions: Drug: Nicotine Replacement; Other: Questionnaire Administration; Device: Electronic Cigarette

• Registration Number: NCT03856515
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Study Timeline

• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-02-25
• Study First Posted: 2019-02-27
• Study Start: 2022-06-02
• Primary Completion: 2024-06-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-11
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

• Aged 21 years or older
• Reports being a daily or non-daily smoker (any self-reported smoking in the past 30 days)
• Have an address where he/she can receive mail
• Able to follow verbal and written instructions in English and complete all aspects of the study as determined by PI
• Willing to have urine biospecimen samples taken, either in-home and returning them by mail, or in-person at an approved collection site.
• Willing to use tobacco-flavored study electronic cigarettes
• Agrees to comply with all MD Anderson institutional policies related to COVID-19 screening prior to any in-person research visit.
• The individual agrees to not engage in study procedures or interactions with study personnel while operating a vehicle.

Read More

Exclusion Criteria

• Individuals who report depressive symptoms in the moderately severe or severe range on the PHQ-9 (scores of 15 or above) or who report current suicidal ideation on the PHQ-9
• Uncontrolled or unstable medical condition (e.g., uncontrolled hypertension, angina, diabetes).
• Evidence of cognitive deficits or instability that would preclude reliable study participation.
• Being pregnant, engaging in breast-feeding, or being of childbearing potential and engaging in sexual activity that could lead to pregnancy and is not protected by a medically acceptable, effective method of birth control while enrolled in the study, as determined by self-report. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use.
• Considered by the investigator to be an unsuitable or unstable candidate (including but not limited to the following situation: unwilling or unable to comply with study procedures)
• Individuals who reside in an area that is outside of our shipping company's area of operation or in a jurisdiction outside of our medical staff's licensure (if unable to attend in-person clinic visits) AND who decline or are unable to come in to clinic to provide necessary samples and/or collect study products.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
E-Cig nicotine dose followed by E-Cig placebo dose	Electronic Cigarette	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.
E-Cig placebo dose followed by E-Cig nicotine dose	Electronic Cigarette	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.
E-Cig nicotine dose followed by E-Cig placebo dose	Nicotine Replacement	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.
E-Cig placebo dose followed by E-Cig nicotine dose	Nicotine Replacement	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.
E-Cig placebo dose followed by E-Cig nicotine dose	Questionnaire Administration	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.
E-Cig nicotine dose followed by E-Cig placebo dose	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Cigarettes per day (CPD) (Aim 1)	Up to 6 weeks	Assessments will include: product use (CPD, number of electronic-cigarette \[EC\] vaping sessions and minutes of use, expired carbon monoxide \[CO\], nicotine, cotinine, and anabasine); product acceptability (explicit product liking, implicit product liking, and perceived product harm); reinforcement (RRE) and nicotine dependence symptoms (withdrawal, craving, and affect).
Differences between male or female smokers (Aim 2)	Up to 6 weeks	Will characterize the differences between male and female combustible cigarette (CC) smokers when switching to nicotine versus placebo standard research E-cigarettes (SRECs) from CCs on product use, product acceptability, reinforcement, and nicotine dependence symptoms. Will examine the moderating role of gender on the impact of SREC) type on the assessments described in Aim 1.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States