drugset / Trial / NCT02796391

Facilitating Smoking Cessation With Reduced Nicotine Cigarettes

NCT02796391 ↗

RandomizedParallel-groupDouble-blindPrevention

Summary

STUDY 1: INTERVENTION DEVELOPMENT The purpose of this study is to determine the best way to help people stop smoking by using very low nicotine content (VLNC) cigarettes. This developmental pilot study (n=20) will determine the feasibility of the treatment approach and methodology using a targeted intervention, and lead to refinements for a subsequent randomized controlled trial (RCT). STUDY 2: RANDOMIZED CONTROLLED TRIAL The purpose of this study is to see if a targeted intervention will help people to stop or reduce smoking better than a standard intervention using very low nicotine content (VLNC) cigarettes, and to determine the optimal nicotine tapering schedule (gradual vs. immediate) during a 5-week pre-quit period. About 208 participants will take part in this phase of the study at Moffitt Cancer Center.

Timeline

Start
2017-09-07
Primary completion
2021-08-24
Completion
2021-08-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Very Low Nicotine Content (VLNC) Cigarettes Unknown 0.03 mg —

Indications

No indication recorded.