Team IMPACT's Ongoing & Past Studies

Alternative Tobacco Products

ESCAPE

PI: Dr. Tracy Smith

ESCAPE (Evaluating the Success of flavored e-Cigarettes for Achieving Prolonged smoking abstinencE) is co-led by Dr. Smith and Dr. Theodore Wagener at Ohio State University. ESCAPE is a NIDA and FDA-funded nationwide clinical trial which will investigate the impact of e-cigarette flavoring on switching from cigarettes to e-cigarettes among current cigarette smokers.

People who currently smoke cigarettes (N=1500) will be recruited nationally and will receive 12 weeks of e-cigarettes or nicotine replacement therapy. Participants will try to switch completely to their assigned product and will complete regular remote data assessments.

This study is ongoing with an expected end date of 04/2028. Results are usually available within 9 to 12 months after that, so come back to this site to learn more about this study.

Switch or Quit

PI: Dr. Tracy Smith

Switch or Quit investigates the potential for e-cigarettes to reduce the harms from tobacco among people who have tried to quit with FDA-approved pharmacotherapy and were unable to do so. People who currently smoke cigarettes (N=225) will be recruited statewide and receive either 9 weeks of e-cigarette product or 9 weeks of FDA approved medication.

People who receive medication will choose between nicotine replacement therapy and varenicline. Participants will set a date on which they plan to stop smoking completely and use their assigned products instead. Participants will complete regular phone calls and daily diaries throughout the study.

This study is ongoing with an expected end date of 05/2027. Results are usually available within 9 to 12 months after that, so come back to this site to learn more about this study.

DUET

PI: Dr. Matthew Carpenter

DUET (Dual Use Evaluation and Tracking) is a newly NIH/NIDA-funded trial to examine the trends of exclusively combustible cigarette use, exclusively electronic cigarette use, and dual use. Dual use is known as the co-use of both electronic cigarettes and combustible cigarettes together.

Participants in all three cohorts will be asked to complete several diaries and surveys over the course of a year regarding their smoking habits, so researchers can further understand the natural patterns of use across all groups.

This study is ongoing with an expected end date of 01/2029. Results are usually available within 9 to 12 months after that, so come back to this site to learn more about this study.

Cigarette Regulation

MINT

PI: Dr. Tracy Smith

MINT (Menthol’s Impact on Nicotine and Tobacco use) is a NIDA and FDA-funded R01 to examine the impact of menthol regulation in cigarettes and e-cigarettes among people who currently smoke menthol cigarettes. People who currently smoke menthol cigarettes in Charleston, Florence, and Lancaster, SC will receive either menthol or non-menthol cigarettes and menthol or tobacco flavored e-cigarettes for six weeks.

During the trial, participants will be asked to only use cigarettes and e-cigarettes provided to them by the study, although there is no requirement to use either product. Participants will try to stop using cigarettes during the seventh week.

This study is ongoing with an expected end date of 08/2027. Results are usually available within 9 to 12 months after that, so come back to this site to learn more about this study.

Smoking Cessation

ADAPT

PIs: Drs. Tracy Smith and Matthew Carpenter

ADAPT (Adaptive Directions after Pharmacotherapy Treatment) is a newly funded trial from the National Cancer Institute (NCI). It will examine different options for treatment. All smokers will be given an FDA-approved medication to help them quit.

Depending on early response to treatment, they will either get more of this same medication, another medication, or a harm-reduction product (e-cigarette). The study will recruit 544 adult smokers across South Carolina and Alabama.

This study is ongoing with an expected end date of 03/2028. Results are usually available within 9 to 12 months after that, so come back to this site to learn more about this study.

ADAPT Eligibility Screening

STEPS

PIs: Drs. Tracy Smith and Erin McClure

STEPS (Substance use Trial of E-cigarettes or Pharmacotherapy for Smoking) is co-lead by Dr. Tracy Smith and Dr. Erin McClure at MUSC. This study investigates whether non-cigarette tobacco products, namely e-cigarettes (nicotine vapes), can help people who smoke and are in treatment for substance use disorder quit smoking by switching completely to e-cigarettes as compared to FDA-approved medications, namely nicotine replacement therapy in the form of patches and lozenges. Participation lasts 6 months and includes five in-person study visits and eleven virtual assessments. Participants also complete a short daily diary on their phones each day for the first twelve weeks. We are not currently recruiting from the community, but participants are eligible to enroll if they are receiving treatment at one of several treatment programs across South Carolina. 

Past Studies

STARS

PI: Dr. Matthew Carpenter

STARS (Smoking Treatment and Remote Sampling) was an NCI-funded R01 that examined the impact of varenicline vs. NRT vs. no medication sampling. Study participants (N=651) were adult smokers across South Carolina who did and did not want to quit. Participants were given a month supply of medication (or not) and were prospectively followed for six months to evaluate outcomes.

Primary results have now been published in JAMA Network Open, available here. We demonstrated that varenicline sampling is efficacious, with potentially superior outcomes compared with NRT. Results provide additional evidence in support of medication sampling as a pragmatic option to engage smokers in smoking cessation, worth further evaluation within an applied settings. We anticipate other manuscripts from this trial in the months to come.

K01

PI: Dr. Tracy Smith

This trial investigates the impact of different e-cigarette device characteristics on reinforcement value, e-cigarette uptake, and downstream effects on cigarette smoking. Smokers (N=180) are recruited locally and will receive an e-cigarette and e-liquid for 3 weeks. The e-cigarette will either have a higher or lower device wattage, and the e-liquid will either have a higher or lower nicotine concentration. Participants sample the product in the lab and then take it home for 3 weeks to use as they wish. Participants return to the lab weekly to receive more e-liquids. There is no requirement to quit or change smoking.

CONNECT

PI: Dr. Matthew Carpenter

CONNECT (Clinical Outcomes for a Nationwide, Naturalistic E-Cigarette Trial) was a NCI-funded R01 that examined uptake, patterns of use, biomarkers, and behavioral consequences of sampling an e-cigarette (vs. not). Smokers (N=638) were recruited nationally and locally and randomized to receive a tank-style e-cigarette device, vs. not, for self-determined use over 1 month, with prospective follow-up through 6 months. The main study outcomes have now been published in Lancet eClinical Medicine, available here. We found that unguided e-cigarette use leads to smoking cessation, allaying the notion that causal effects of e-cigarettes on cessation are not reflective of real-world scenario of self-determined use. For smokers who may not be able to quit using existing pharmacologic approaches, e-cigarettes may be considered to achieve that purpose.

Additional publications from this trial include: a) an analysis of shifting perceptions of e-cigarettes over time, available here, b) an evaluation of dual use (using both combustible and e-cigarettes) over time, available here, c) an assessment of e-cigarette flavoring on e-cigarette use and cessation outcomes, available here, d) a methods paper on novel strategies to recruit participants in remote trials, available here, and e) a paper that examined the relationship between intentions to use e-cigarettes and patterns of actual use, available here.