Back to results

Effects of Random Nicotine Delivery on Smoking Cessation

Primary Purpose

Smoking Cessation, Cigarette Smoking, Smoking (Tobacco) Addiction

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Nicotine Film

About this trial

This is an interventional treatment trial for Smoking Cessation focused on measuring smoking cessation, nicotine film, nicotine delivery, random nicotine delivery

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

Penn State Health Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Random Nicotine Delivery

Steady State Nicotine Delivery

Placebo Control

Arm 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.

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

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

Outcomes

Primary Outcome Measures

Change in Number of Cigarettes Smoked Per Day (CPD)

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.

Change in Exhaled Carbon Monoxide (CO) Measurement

Mean change in exhaled CO (parts per million [ppm])

Secondary Outcome Measures

Change in Questionnaire of Smoking Urges-Brief (QSU-Brief) Total Score

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.

Change in Fagerstrom Test for Nicotine Dependence (FTND) Total Score

Nicotine dependence will be assessed via the FTND, a measure with total scores ranging from 0 (very low dependence) to 10 (very high dependence).

Subjective Ratings Scale for Nicotine Film Use

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.

Side Effects From Nicotine Film Use

Total score ranges from 0 - 36 with lower scores indicating lesser side effects.

Full Information

NCT ID

NCT03674970

First Posted

September 14, 2018

Last Updated

January 3, 2021

Sponsor

Milton S. Hershey Medical Center

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT03674970

Brief Title

Effects of Random Nicotine Delivery on Smoking Cessation

Official Title

Effects of Random Nicotine Delivery on Smoking Cessation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

March 12, 2019 (Actual)

Primary Completion Date

November 25, 2019 (Actual)

Study Completion Date

November 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Milton S. Hershey Medical Center

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smoking Cessation, Cigarette Smoking, Smoking (Tobacco) Addiction

Keywords

smoking cessation, nicotine film, nicotine delivery, random nicotine delivery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Random Nicotine Delivery

Arm Type

Experimental

Arm 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.

Arm Title

Steady State Nicotine Delivery

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo Control

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nicotine Film

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Number of Cigarettes Smoked Per Day (CPD)

Description

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.

Time Frame

Baseline and 4 weeks after Target Quit Date

Title

Change in Exhaled Carbon Monoxide (CO) Measurement

Description

Mean change in exhaled CO (parts per million [ppm])

Time Frame

Baseline and 4 weeks after Target Quit Date

Secondary Outcome Measure Information:

Title

Change in Questionnaire of Smoking Urges-Brief (QSU-Brief) Total Score

Description

Time Frame

Baseline and 4 weeks after Target Quit Date

Title

Change in Fagerstrom Test for Nicotine Dependence (FTND) Total Score

Description

Nicotine dependence will be assessed via the FTND, a measure with total scores ranging from 0 (very low dependence) to 10 (very high dependence).

Time Frame

Baseline and 4 weeks after Target Quit Date

Title

Subjective Ratings Scale for Nicotine Film Use

Description

Time Frame

4 weeks after Target Quit Date

Title

Side Effects From Nicotine Film Use

Description

Total score ranges from 0 - 36 with lower scores indicating lesser side effects.

Time Frame

4 weeks after Target Quit Date

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patricia S Grigson, PhD

Organizational Affiliation

Penn State College of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jonathan Foulds, PhD

Organizational Affiliation

Penn State College of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Christopher Sciamanna, MD

Organizational Affiliation

Penn State College of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Penn State Health Milton S. Hershey Medical Center

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effects of Random Nicotine Delivery on Smoking Cessation

We'll reach out to this number within 24 hrs