Effects of Random Nicotine Delivery on Smoking Cessation

Penn State Health

Status and phase

Completed

Phase 2

Phase 1

Conditions

Smoking (Tobacco) Addiction

Cigarette Smoking

Smoking Cessation

Treatments

Drug: Nicotine Film

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03674970

9977

R21DA038775 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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:

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

Enrollment

45 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

45 participants in 3 patient groups, including a placebo group

Random Nicotine Delivery

Experimental group

Description:

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.

Treatment:

Drug: Nicotine Film

Steady State Nicotine Delivery

Active Comparator group

Description:

One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.

Treatment:

Drug: Nicotine Film

Placebo Control

Placebo Comparator group

Description:

One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.