Pharmacokinetics of Nicotine Sublingual Tablets Versus Nicorette Lozenge in Healthy Smokers

Completed · Phase 1

Conditions studied: Tobacco Use Disorder, Cigarette Smoking

In brief

The purpose of the study is to compare two different dosage forms from which nicotine is released and absorbed into the bloodstream.

Key facts

Study ID

NCT02906995

Run by

Friends Research Institute, Inc.

People needed

24

Starts

2017-05-25

Expected to finish

2017-11-27

Last updated by the study team

2017-12-04

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants have to be 18-45 years old
• Participants must provide written informed consent prior to any study related procedures being performed.
• Participants must have a willingness and ability to comply with the protocol requirements.
• Participants must be in good health and free from any clinically significant pathology (gastrointestinal tract, hepatic, renal, cardiovascular, CNS diseases)
• Female participants of childbearing potential, in addition to having a negative urine pregnancy test, must be willing to use a form of birth control during the study. The hormonal contraceptives should be avoided within 2 month prior to study entry.
• Participants must consume more than 10 cigarettes daily and Fagerström Test for Nicotine Dependence score of 4 or greater.
• Participants must have no intention of quitting smoking in the next 60 days.

You may not qualify if…

• Volunteers that have used other nicotine delivery system such as nicotine lozenge, nicotine patch, nicotine inhaler, or nicotine nasal spray etc within 30 days of study entry.
• Volunteers who have currently involved in another clinical trial or have used any investigational drug within 3 month of study entry.
• Volunteers who are pregnant or lactating, or plan to become pregnant within 6 months.
• Volunteers who have diagnosed heart disease or are being treated with medication or had an irregular heartbeat or have had a myocardial infarction.
• Volunteers with diagnosed stomach ulcers.
• Volunteers who are taking insulin for diabetes.
• Volunteers with high blood pressure not controlled by medication or a blood pressure greater than 150 mmHg systolic or 90 mmHg diastolic.
• Volunteers who are unable to fulfill the visit schedule
• Volunteers who have severe allergic history
• Volunteers who have known intolerance to medication
• Volunteers who have diagnosed chronic diseases of cardiovascular, pulmonary, neuro-endocrine systems, gastrointestinal, hepatic, renal, and blood diseases
• Volunteers who had surgical operations on gastrointestinal tract with the exception of appendectomy
• Volunteers who donated 450 mL and more of his/her blood or blood plasma within the last 2 months prior to the study entry
• Volunteers who meet criteria for dependence on a substance other than nicotine.
• Participants having a body mass index below 18 or over 35.

Where it is running

• Rose Research Center — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.