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Nicotine Replacement Therapy

Product Sequence 1 for Tobacco Use

N/A

Waitlist Available

Research Sponsored by Philip Morris Products S.A.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has smoked on average ≥10 commercially available regular CIG/day over the last 4 weeks. Smoking status will be verified based on a urinary cotinine test (cotinine ≥200 ng/mL).

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured from start of product use (t0) to 2 minutes, to 4 minutes, to 10 hours, to time of last quantifiable concentration.

Awards & highlights

Study Summary

This trial tests the effectiveness of 4 types of nicotine products to help adult smokers quit. Subjects will be given the products in random order, without knowing which one they're getting.

Who is the study for?

This trial is for adult cigarette smokers who want to participate in a study comparing the nicotine delivery from two new products, NP2-4mg and NP2-6mg, with standard nicotine lozenges and gum. Specific eligibility criteria are not provided.Check my eligibility

What is being tested?

The study tests how the body absorbs nicotine from two doses of a new product (NP2) against traditional 4mg nicotine lozenges and gums. Participants will try all four options in different orders without knowing which one they're using at any time.See study design

What are the potential side effects?

Possible side effects may include those typically associated with nicotine products such as headache, nausea, dizziness, heartburn, or hiccups. The exact side effects of the new NP2 variants are not detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have smoked 10 or more cigarettes daily for the past month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured from start of product use (t0) to 2 minutes, to 4 minutes, to 10 hours, to time of last quantifiable concentration.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured from start of product use (t0) to 2 minutes, to 4 minutes, to 10 hours, to time of last quantifiable concentration.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured from start of product use (t0) to 2 minutes, to 4 minutes, to 10 hours, to time of last quantifiable concentration. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the observed concentration-time curve (AUC) from start of product use (T0) to timepoint of last quantifiable concentration [AUC0-last] and extrapolated to infinity [AUC0-infinity]

Elimination rate constant [kel]

Half-life of nicotine [t1/2]

+3 more

Trial Design

4Treatment groups

Active Control

Group I: Product Sequence 1Active Control4 Interventions

From Day 1 to Day 4, after at least 23 hours of abstinence from any nicotine/tobacco containing products, subjects will use one of the four investigational products according to randomized product use sequence and as instructed by the investigational site personnel. The list of possible sequences are: NP2-4mg; NP2-6mg; Loz-4mg; Gum-4mg / NP2-6mg; Gum-4mg; NP2-4mg; Loz-4mg / Gum-4mg; Loz-4mg; NP2-6mg; NP2-4mg / Loz-4mg; NP2-4mg; Gum-4mg; NP2-6mg

Group II: Product Sequence 2Active Control4 Interventions

Group III: Product Sequence 3Active Control4 Interventions

Group IV: Product Sequence 4Active Control4 Interventions

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Philip Morris Products S.A.Lead Sponsor

46 Previous Clinical Trials

31,827 Total Patients Enrolled

6 Trials studying Tobacco Use

20,481 Patients Enrolled for Tobacco Use

Christelle Haziza, PhDStudy ChairPhilip Morris Products S.A.

27 Previous Clinical Trials

7,422 Total Patients Enrolled

2 Trials studying Tobacco Use

1,895 Patients Enrolled for Tobacco Use

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who has the qualifications to be a part of this clinical research?

"The clinical trial is accommodating 56 individuals with a tobacco use history between 18 and 55 years old."

Answered by AI

Does this research accept participants older than thirty years of age?

"According to trial eligibility criteria, the age range for participants is limited to persons between 18 and 55 years old. Patients younger than 18 or older than 65 can find 8 and 34 trials respectively that match their demographic."

Answered by AI

Could you provide an estimate of the number of participants enrolled in this trial?

"Affirmative. According to the records hosted on clinicaltrials.gov, this medical trial is now actively recruiting participants across 2 sites after being posted in October of 2023 and last modified in December of 2023. A total of 56 patients are desired for enrolment into the study."

Answered by AI

Are individuals being accepted to participate in this scientific exploration at present?

"Indeed, the particulars on clinicaltrials.gov reveal that this particular trial is actively enrolling patients as of now. Originally posted on October 20th 2021 and subsequently updated on December 13th 2021, it seeks 56 volunteers from 2 sites for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pharmacokinetics and Comparative Bioavailability of Nicotine From Two Variants of NP2, NP2-4mg and NP2-6mg, Compared to Nicotine Lozenge 4mg (Loz-4mg) and Nicotine Gum 4mg (Gum-4mg)

2023. "Pharmacokinetics and Comparative Bioavailability of Nicotine From Two Variants of NP2, NP2-4mg and NP2-6mg, Compared to Nicotine Lozenge 4mg (Loz-4mg) and Nicotine Gum 4mg (Gum-4mg)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06171490.