Effects of Random Nicotine Delivery on Smoking Cessation

Phase 1

Completed

• Conditions: Cigarette Smoking; Smoking Cessation; Smoking (Tobacco) Addiction
• Interventions: Drug: Nicotine Film

• Registration Number: NCT03674970
• Lead Sponsor: Milton S. Hershey Medical Center

Brief 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.

Detailed Description

This project is a prospective parallel-group, randomized, double-blind, placebo-controlled study in which 45 current cigarette smokers who are interested in quitting will be randomly allocated to one of three possible nicotine film treatment regimens:

1. Random nicotine delivery (a combination of four 0 mg and 4 mg films daily not to exceed three non-consecutive 4 mg films in one day and to maintain an average of 8 mg of nicotine per day through 7 days for 6 weeks total).

2. Steady state nicotine delivery (2, 2, 2, 2 mg films daily for 6 weeks total)

3. Placebo delivery (0, 0, 0, 0 mg films daily for 6 weeks total)

Prior to assignment in one of the above treatment groups, all participants will take part in a 1-week baseline period to assess normal smoking behavior and nicotine dependence. Following randomization to their assigned treatment group at Visit 2, participants will be instructed to smoke cigarettes as they feel necessary over the next two weeks while using the nicotine films as directed (i.e., one film every 3-4 hours for a total of four films per day). After two weeks of pre-cessation treatment, participants will be asked completely cease cigarette smoking and to only use their assigned nicotine films as directed. Participants will be supported in their quitting efforts with regular contacts both in person at the Penn State Milton S. Hershey Medical Center and over the phone.

Study Timeline

• Study First Submitted: 2018-09-14
• Study First Submitted QC: 2018-09-14
• Study First Posted: 2018-09-18
• Study Start: 2019-03-12
• Primary Completion: 2019-11-25
• Study Completion: 2019-11-25
• Results First Submitted: 2020-11-24
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-03
• Last Update Submitted: 2021-01-03
• Results First Posted: 2021-01-22
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Aged 18-55
• Smoke ≥10 cigarettes/day for at least the past 12 months
• Exhaled CO measurement ≥6 ppm at baseline visit
• Interested in completely ceasing cigarette consumption and using a nicotine film product as directed
• Willing to attend regular visits over a 6-week period (not planning to move, not planning extended vacation, no planned surgeries)
• Able to read and write in English
• Able to understand and consent to study procedures

Exclusion Criteria

• Unstable or significant medical conditions and conditions such as elevated blood pressure (systolic >159 mmHg or diastolic >99mmHg at baseline), COPD, and those conditions that are likely to affect biomarker data such as kidney or liver disease
• Individuals with sodium-restricted diet, heart disease, recent heart attack, irregular heartbeat, stomach ulcers, or diabetes as well as those taking prescription medications for depression or asthma as indicated under "Warnings" section on FDA approved NRT Drug Facts Label
• More than weekly use in the past 3 months of illegal drugs or prescription drugs that are not being used for medically prescribed purposes
• Use of non-cigarette nicotine delivery product in the prior 7 days (including cigars, pipes, chew, snus, hookah, electronic cigarette and marijuana mixed with tobacco)
• Use of an FDA approved cessation medication in the past 7 days (any NRT, Chantix, Wellbutrin)
• Women who are pregnant (verified by urine pregnancy test at baseline visit), trying to become pregnant, or nursing
• Uncontrolled mental illness or substance abuse or inpatient treatment for these conditions in the past 6 months
• Any previous adverse reaction to NRT
• Any other condition, serious illness, or situation that would, in the investigator's opinion, make it unlikely that the participant could comply with the study protocol
• Other member of household currently participating in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Random Nicotine Delivery	Nicotine Film	One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks.
Steady State Nicotine Delivery	Nicotine Film	One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.
Placebo Control	Nicotine Film	One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Exhaled Carbon Monoxide (CO) Measurement	Baseline and 4 weeks after Target Quit Date	Mean change in exhaled CO (parts per million \[ppm\])
Change in Number of Cigarettes Smoked Per Day (CPD)	Baseline and 4 weeks after Target Quit Date	CPD is measured with the use of daily cigarette logs which are completed daily by participants and returned to the study center at each visit. The CPD measure will be the average of the past 7 days.

Secondary Outcome Measures

Name	Time	Method
Change in Questionnaire of Smoking Urges-Brief (QSU-Brief) Total Score	Baseline and 4 weeks after Target Quit Date	The QSU-Brief, with a possible total score range of 10 to 70, is an instrument used to measure cigarette craving. A score of 10 on this scale indicates very low cigarette craving, while a score of 70 indicates very high cigarette craving.
Subjective Ratings Scale for Nicotine Film Use	4 weeks after Target Quit Date	The scale is comprised of 21 items. Each item is rated on a scale 1-7, where 1 is equal to not at all and 7 is equal to extremely. The total score is the average score of all 21 items. The total score ranges from 1-7.
Change in Fagerstrom Test for Nicotine Dependence (FTND) Total Score	Baseline and 4 weeks after Target Quit Date	Nicotine dependence will be assessed via the FTND, a measure with total scores ranging from 0 (very low dependence) to 10 (very high dependence).
Side Effects From Nicotine Film Use	4 weeks after Target Quit Date	Total score ranges from 0 - 36 with lower scores indicating lesser side effects.

Trial Locations

Locations (1)

Penn State Health Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States