Switching to E-Cigarettes for Smoking Reduction

Recruiting in Palo Alto (17 mi)

Overseen byJason Robinson

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jason Robinson

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adult smokers who've been smoking at least 5 cigarettes daily for the past month, have a stable address and phone, can follow instructions in English, and are willing to switch to tobacco-flavored e-cigarettes. Pregnant or breastfeeding women, those not using birth control, people with severe lung obstruction or unstable health conditions like uncontrolled diabetes or hypertension cannot join.

Inclusion Criteria

You are okay with using e-cigarettes that have a tobacco flavor for the study.

You are able to follow verbal and written instructions in English and complete all aspects of the study as determined by the PI.

A stable address and working telephone

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Exclusion Criteria

I have been diagnosed with major depression or have had suicidal thoughts.

I have recently started or plan to start a program to quit smoking soon.

My lung function test shows severe to very severe obstruction.

See 7 more

Treatment Details

Interventions

Electronic Cigarette (Electronic Cigarette)
Nicotine Replacement (Nicotine Replacement)

Trial OverviewThe study aims to understand gender differences when switching from regular cigarettes to electronic ones provided by the research team. Participants will use these e-cigarettes and complete questionnaires while their lung function is tested twice during the study.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: E-Cig placebo dose followed by E-Cig nicotine doseExperimental Treatment3 Interventions

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.

Group II: E-Cig nicotine dose followed by E-Cig placebo doseExperimental Treatment3 Interventions