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

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.

Study Overview

• Status: Recruiting
• Conditions: Cigarette Smoking-Related Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Drug: Nicotine Replacement; Device: Electronic Cigarette; Device: Electronic Cigarette

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 Type: Interventional
• Enrollment (Estimated): 196
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jason Robinson; Phone Number: 713-792-2265; Email: nicotinestudy@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Jason Robinson; Phone Number: 713-792-0919
      • Principal Investigator: Jason Robinson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E-Cig placebo dose followed by E-Cig nicotine dose; 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.	Other: Questionnaire Administration; Ancillary studies; Drug: Nicotine Replacement; Received NRT (Electronic Cigarette - With Nicotine); Other Names: Nicotine Replacement Therapy; NRT; Device: Electronic Cigarette; Electronic Cigarette - with Nicotine; Device: Electronic Cigarette; Electronic Cigarette -without Nicotine
Experimental: E-Cig nicotine dose followed by E-Cig placebo dose; 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.	Other: Questionnaire Administration; Ancillary studies; Drug: Nicotine Replacement; Received NRT (Electronic Cigarette - With Nicotine); Other Names: Nicotine Replacement Therapy; NRT; Device: Electronic Cigarette; Electronic Cigarette - with Nicotine; Device: Electronic Cigarette; Electronic Cigarette -without Nicotine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cigarettes per day (CPD) (Aim 1)	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).	Up to 6 weeks
Differences between male or female smokers (Aim 2)	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.	Up to 6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderators and mediators of switching to e-cigarettes (with and without nicotine) from regular cigarettes (Exploratory Aim)	In an exploratory fashion, will examine whether baseline factors, including prior EC exposure and prior flavor preference, menthol CC preference, nicotine dependence, baseline total nicotine equivalents (TNE), and race/ethnicity, moderate the Aims 1 & 2 hypotheses. Will also examine the potentially mediating effects of product satisfaction, hormonal contraception use, menstrual phase, and smartphone-collected withdrawal, craving, affect, product use on these hypotheses.	Up to 6 weeks

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Jason Robinson, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2018-0794 (Other Identifier: M D Anderson Cancer Center); NCI-2018-03354 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); U01DA047875 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes