CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Nicotine Filmdrug
Likely dose
Nicotine Film 0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03674970
NCT03674970Phase 2Completed
CompareCT.gov

Effects of Random Nicotine Delivery on Smoking Cessation

Milton S. Hershey Medical Center·interventional·Posted Sep 18, 2018·Updated Jan 22, 2021

In Brief

A Phase 2 clinical trial evaluating Nicotine Film for Smoking Cessation and 2 related conditions. Completed, enrolled 45 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation, Cigarette Smoking, Smoking (Tobacco) Addiction
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedSep 18, 2018
Enrollment StartMar 12, 2019
Primary CompletionNov 25, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.8 years ago

Interventions

Nicotine Filmdrug

Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg. The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.