Clinical trial NCT03856515: Gender Differences in Switching From Smoking Regular Cigarettes to E-Cigarettes
Official title: Gender Differences in Standardized Research E-Cigarette (SREC) Product Use, Acceptability, Reinforcement, and Nicotine Dependence Symptoms
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cigarette Smoking-Related Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-02-27
Enrollment: 169
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cigarettes per day (CPD) (Aim 1)
timeFrame: Up to 6 weeks
measure: Differences between male or female smokers (Aim 2)
timeFrame: Up to 6 weeks
Secondary outcomes:
Other outcomes:
measure: Moderators and mediators of switching to e-cigarettes (with and without nicotine) from regular cigarettes among male and female CC smokers (Exploratory Aim)
timeFrame: Up to 6 weeks
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jason Robinson
role: PRINCIPAL_INVESTIGATOR
References: