drugset / Trial / NCT03674970
Effects of Random Nicotine Delivery on Smoking Cessation
Phase 1/2
Completed
45 enrolled
Milton S. Hershey Medical Center
National Institute on Drug Abuse (NIDA) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nicotine | Unknown | 0 mg | Oral |
| Subject | Nicotine | Unknown | 2 mg | Oral |
| Subject | Nicotine | Unknown | 4 mg | Oral |