Pharmacokinetics of Nicotine Sublingual Tablets Versus Nicorette Lozenge in Healthy Smokers

NCT02906995 | Completed Phase 1

• 1 other identifier: 16-07-239
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tobacco Use Disorder; Cigarette Smoking

Keywords

pharmacokinetics; nicotine absorption

Outcome Measures

Primary Outcomes (1)

• the time course profile of nicotine absorption from the two nicotine dosage forms.

  Fourteen blood samples will be collected over a 240 minute period after drug administration.

Secondary Outcomes (2)

• Assessment of craving for a cigarette

  The craving assessment will be obtained at 1, 3, 7, 11,and 14 minutes after drug administration

• Safety assessments: Vital signs

  Vital signs will be measured prior to drug administration, 3 times in the first 30 minutes, and prior to discharge at 240 minutes.

Study Arms (2)

Sublingual tablet 4 mg

EXPERIMENTAL

The 24 study participants will be administered the sublingual 4 mg nicotine tablet on one occasion. Blood samples will be obtained for 4 hours for analysis of nicotine plasma levels.

Drug: Sublingual tablet 4 mg versus Nicorette Lozenge 4mg

Nicorette lozenge 4 mg

ACTIVE COMPARATOR

The 24 study participants will be administered the Nicorette lozenge containing 4 mg of nicotine on one occasion. Blood samples will be obtained for 4 hours for analysis of nicotine plasma levels.

Drug: Sublingual tablet 4 mg versus Nicorette Lozenge 4mg

Interventions

Sublingual tablet 4 mg versus Nicorette Lozenge 4mg DRUG

* One dose of study drug (sublingual tablet or Nicorette Lozenge) will be administered to each subject in the morning on Day 1. * The second administration of drug will occur at least 48 hours after the initial administration. Subjects will receive the other dosage form and be instructed according to whether they are receiving the sublingual tablet or the lozenge.

Also known as: Pharmacokinetic comparison of two nicotine dosage forms

Nicorette lozenge 4 mg; Sublingual tablet 4 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead
• Rose Research Center, LLC: collaborator

Study Sites (1)

Rose Research Center

Raleigh, North Carolina, 27617, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Cigarette Smoking

Interventions

Administration, Sublingual

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Administration, Oral; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Frank J Vocci, Ph.D.

  Friends Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2016
• First Posted: September 20, 2016
• Study Start: May 25, 2017
• Primary Completion: November 27, 2017
• Study Completion: November 27, 2017
• Last Updated: December 4, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)