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Nicotine Replacement Therapy

Nicotine Products for Smoking Cessation

Phase 3

Recruiting

Research Sponsored by Rose Research Center, LLC

Eligibility Criteria Checklist

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

Must have

Age 22 to 65 years at time of screening (verified by government issued ID)

Currently smokes at least 10 tobacco cigarettes per day

Must not have

Unable to read, speak or understand English

Heterosexually active participants of Childbearing Potential not using medically appropriate birth control methods

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12, week 24, week 36

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

"This trial aims to see if smokers who cut down their smoking by at least half in the first two weeks using nicotine products like e-cigarettes or nicotine replacement therapy can continue using these products for six months.

Who is the study for?

This trial is for smokers who have managed to cut their smoking by at least half within two weeks using nicotine products. They should be aiming to maintain this reduction or quit smoking for six months. Specific eligibility criteria are not provided, so general health conditions and other factors that typically exclude participants from clinical trials may apply.

What is being tested?

The study tests if smokers can keep up reduced smoking or stop entirely over six months using nicotine alternatives like patches (Nicoderm), lozenges (Nicorette), e-cigarettes (NJOY), gum (Nicorette Gum), and pouches (on!). It checks the adaptability of these products in maintaining long-term changes in smoking habits.

What are the potential side effects?

Possible side effects might include skin irritation from patches, mouth issues from lozenges and gum, throat irritation from e-cigarettes, and nausea or hiccups from nicotine intake. Individual reactions can vary based on product use.

Eligibility Criteria

Inclusion Criteria

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

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I am between 22 and 65 years old.

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I currently smoke 10 or more cigarettes daily.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot read, speak, or understand English.

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I am sexually active, can become pregnant, and am not using birth control.

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I have recently used nicotine products or medications to quit smoking.

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I am not pregnant, nursing, nor planning to become pregnant during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12, week 24, week 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12, week 24, week 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12, week 24, week 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Smoking abstinence - CO

Secondary study objectives

Reduction in Expired Air CO

Saliva Cotinine Concentrations

Smoking abstinence - Self report of no smoking

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Nicotine Responders - Group 2Experimental Treatment5 Interventions

Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 22 weeks (24-week total treatment period).

Group II: Nicotine Responders - Group 1Experimental Treatment5 Interventions

Group III: Nicotine Non-RespondersExperimental Treatment5 Interventions

Participants that were not successful in reducing their expired carbon monoxide by the end of week 2 will not continue in the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicoderm

2005

N/A

~30

0 / 6Eligibility criteria met