E-cigarette Nicotine Study

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot randomized controlled trial (RCT) with the overarching aim of testing the influence of reducing electronic nicotine delivery system (ENDS) use or nicotine on addiction and combustible cigarette (CC) smoking among dual users. Specifically, the investigators will conduct a 4-week pilot RCT in which dual users who are not motivated to quit either product in the near future are randomized to A) abruptly switch to low nicotine ENDS pods, B) abruptly reduce number of usual nicotine ENDS pods, or C) use ENDS as usual (control). The investigators adapted a protocol used in a prior study to assign participants to switch to ENDS pods with less nicotine or reduce number of ENDS pods in this trial. Specifically, the investigators will provide all participants with ENDS pods during the study period and instruct them to only use ENDS provided by the study. Participants in reduced nicotine condition will switch from usual nicotine (5% JUUL) to low nicotine ENDS (3% nicotine JUUL) pods. Participants in the reduced use condition will continue to use usual nicotine ENDS (5% nicotine JUUL) pods but reduce use to 60% of their baseline number of pods per week. Participants in the control condition will use usual nicotine ENDS (5% nicotine JUUL) pods as usual.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Vermont
• Treatments: Nicotine

Criteria

Eligibility criteria include at least 21 years old, use e-cigarettes and tobacco cigarettes regularly, not planning to quit in the near future, and not pregnant, breastfeeding or planning to become pregnant or breastfeed in the next 2 months.

Additional criteria will be evaluated to assess for eligibility.