Effects of Random Nicotine Delivery on Smoking Cessation

• Status: Completed
• Trial end date: 2019-11-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Nicotine

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