Effects of Random Nicotine Delivery on Smoking Cessation

NCT ID: NCT03674970

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-12
• Study Completion Date: 2019-11-25

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.

Conditions

Smoking Cessation; Cigarette Smoking; Smoking (Tobacco) Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Random Nicotine Delivery

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.

Group Type: EXPERIMENTAL

Nicotine Film

Intervention Type: DRUG

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.

Steady State Nicotine Delivery

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

Group Type: ACTIVE_COMPARATOR

Nicotine Film

Intervention Type: DRUG

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.

Placebo Control

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

Group Type: PLACEBO_COMPARATOR

Nicotine Film

Intervention Type: DRUG

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.

Interventions

Nicotine Film

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Patricia Sue Grigson

Director, Penn State Addiction Center for Translation and Professor of Neural and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia S Grigson, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Jonathan Foulds, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Christopher Sciamanna, MD

Role: STUDY_DIRECTOR

Penn State College of Medicine

Locations

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R21DA038775

Identifier Type: NIH

Identifier Source: secondary_id

View Link

9977

Identifier Type: -

Identifier Source: org_study_id