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Nicotine Replacement Therapy

sublingual nicotine tablet for Nicotine Study

Phase 1
Waitlist Available
Led By Frank Vocci, Ph.D
Research Sponsored by Pharmaceutical Productions Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of the second dosing day.
Awards & highlights

Summary

The objective of this study is to compare the pharmacokinetics of an investigational 2 mg sublingual nicotine tablet (Pharmaceutical Productions Inc.) to a 2 mg Commit® nicotine lozenge (GlaxoSmith Kline) in a randomized crossover design in 6 male and female otherwise healthy smokers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a craving questionnaire will be administered prior to dosing and at 5, 11, 17, 25, 35, 50, and 65 minutes and will then be administered every 30 minute thereafter up to 180 minute.
This trial's timeline: 3 weeks for screening, Varies for treatment, and a craving questionnaire will be administered prior to dosing and at 5, 11, 17, 25, 35, 50, and 65 minutes and will then be administered every 30 minute thereafter up to 180 minute. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
A Product Preference Questionnaire
The is to compare craving scores for this investigational nicotine replacement therapy (NRT) to the lozenge.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: sublingual nicotine tabletExperimental Treatment1 Intervention
investigational 2 mg sublingual nicotine tablet
Group II: COMMIT nicotine lozengeActive Control1 Intervention
COMMIT 2 mg nicotine lozenge
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Pharmaceutical Productions Inc.Lead Sponsor
National Institute on Drug Abuse (NIDA)NIH
2,543 Previous Clinical Trials
3,249,370 Total Patients Enrolled
Frank Vocci, Ph.DPrincipal InvestigatorFriends Research Institute, Inc.
~0 spots leftby Sep 2025
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