Effects of Random Nicotine Delivery on Smoking Cessation

NCT03674970 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 9977R21DA038775
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Cigarette Smoking; Smoking (Tobacco) Addiction

Keywords

smoking cessation; nicotine film; nicotine delivery; random nicotine delivery

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and 4 weeks after Target Quit Date

• Change in Exhaled Carbon Monoxide (CO) Measurement

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

  Baseline and 4 weeks after Target Quit Date

Secondary Outcomes (4)

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

  Baseline and 4 weeks after Target Quit Date

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

  Baseline and 4 weeks after Target Quit Date

• Subjective Ratings Scale for Nicotine Film Use

  4 weeks after Target Quit Date

• Side Effects From Nicotine Film Use

  4 weeks after Target Quit Date

Study Arms (3)

Random Nicotine Delivery

EXPERIMENTAL

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.

Drug: Nicotine Film

Steady State Nicotine Delivery

ACTIVE COMPARATOR

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

Drug: Nicotine Film

Placebo Control

PLACEBO COMPARATOR

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

Drug: Nicotine Film

Interventions

Nicotine Film 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; Random Nicotine Delivery; Steady State Nicotine Delivery

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Cigarette Smoking; Smoking; Behavior, Addictive

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Tobacco Smoking; Tobacco Use; Compulsive Behavior; Impulsive Behavior

Results Point of Contact

• Title: Patricia Sue Grigson
• Organization: Penn State College of Medicine

pgrigsonkennedy@pennstatehealth.psu.edu

717-531-5772

Study Officials

• Patricia S Grigson, PhD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

• Jonathan Foulds, PhD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

• Christopher Sciamanna, MD

  Penn State College of Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Penn State Addiction Center for Translation and Professor of Neural and Behavioral Sciences

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 18, 2018
• Study Start: March 12, 2019
• Primary Completion: November 25, 2019
• Study Completion: November 25, 2019
• Last Updated: January 22, 2021
• Results First Posted: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)