drugset / Trial / NCT03674970

Effects of Random Nicotine Delivery on Smoking Cessation

NCT03674970

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objective of this study is to determine whether treatment with random nicotine delivery via a nicotine film both before and after the target quit date will facilitate smoking cessation relative to treatment with steady state delivery or placebo. The investigators hypothesize that smoking cessation will be greater in subjects assigned to a random nicotine delivery regimen (as compared to those assigned to a steady state or placebo regimen). The nicotine film product is not part of the standard of care and is not available in non-investigational settings in the United States.

Timeline

Start
2019-03-12
Primary completion
2019-11-25
Completion
2019-11-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Nicotine Unknown 0 mg Oral
Subject Nicotine Unknown 2 mg Oral
Subject Nicotine Unknown 4 mg Oral

Indications