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Nicotine Replacement Therapy

Nicotine Pouches for Preventing Tobacco-Related Cancer

Q: Is this research opportunity currently open to participants?

<p>As indicated on clinicaltrials.gov, the recruitment phase of this medical trial has concluded. It was initially posted in April 1st 2023 and last updated February 14th 2023; however, there are 9 other trials currently enrolling patients at present.</p>

Phase < 1

Recruiting

Led By Brittney L Keller-Hamilton, PhD, MPH

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to study completion, assessed up to 2 years

Awards & highlights

Study Summary

This trial looks at how nicotine patches may help prevent cancer in rural & Appalachian Ohio. Little is known about the appeal & potential health impact of nicotine pouches.

Who is the study for?

This trial is for adults over 21 who live in Ohio Appalachia or nearby rural areas, use smokeless tobacco daily, and can abstain from all tobacco, nicotine, and marijuana before clinic visits. It's not for those with certain lung diseases, oral cancers, recent heart issues, pregnant/breastfeeding women, people planning to quit tobacco soon or using cessation aids.Check my eligibility

What is being tested?

The study looks at the impact of nicotine pouches as a substitute for smokeless tobacco among residents of rural Ohio. Participants will collect biospecimens and answer questionnaires to help researchers understand how these products are adopted and their public health implications.See study design

What are the potential side effects?

Since this trial involves collecting biospecimens and administering questionnaires rather than testing a drug intervention directly on participants' health conditions like cancer itself; it does not list specific side effects related to treatments such as medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to study completion, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to study completion, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to study completion, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Baseline characteristics (Aim 1)

Behavioral intentions (Aim 1)

Plasma nicotine delivery (Aim 1)

+2 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Arm VI (Rogue NP, ZYN NP, usual SLT)Experimental Treatment4 Interventions

Participants receive Rogue brand nicotine patch at study visit 1, ZYN brand nicotine patch at study visit 2, and their usual brand of smokeless tobacco at study visit 3. Participants also undergo IV line insertion and collection of blood on study

Group II: Arm V (Rogue NP, usual SLT, ZYN NP)Experimental Treatment4 Interventions

Participants receive Rogue brand nicotine patch at study visit 1, their usual brand of smokeless tobacco at study visit 2, and ZYN brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

Group III: Arm IV (ZYN NP, Rogue NP, usual SLT)Experimental Treatment4 Interventions

Participants receive ZYN brand nicotine patch at study visit 1, Rogue brand nicotine patch at study visit 2, and their usual brand of smokeless tobacco at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

Group IV: Arm III (ZYN NP, usual SLT, Rogue NP)Experimental Treatment4 Interventions

Participants receive ZYN brand nicotine patch at study visit 1, their usual brand of smokeless tobacco at study visit 2, and Rogue brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

Group V: Arm II (usual SLT, Rogue NP, ZYN NP)Experimental Treatment4 Interventions

Participants receive their usual brand of smokeless tobacco at study visit 1, Rogue brand nicotine patch at study visit 2, and ZYN brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

Group VI: Arm I (usual SLT, ZYN NP, Rogue NP)Experimental Treatment4 Interventions

Participants receive their usual brand of smokeless tobacco at study visit 1, ZYN brand nicotine patch at study visit 2, and Rogue brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor

320 Previous Clinical Trials

290,092 Total Patients Enrolled

Brittney L Keller-Hamilton, PhD, MPHPrincipal InvestigatorOhio State University Comprehensive Cancer Center

3 Previous Clinical Trials

295 Total Patients Enrolled

Media Library

Nicotine Oral Pouch (Nicotine Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05730439 — Phase < 1

Tobacco-Related Cancer Research Study Groups: Arm I (usual SLT, ZYN NP, Rogue NP), Arm II (usual SLT, Rogue NP, ZYN NP), Arm III (ZYN NP, usual SLT, Rogue NP), Arm IV (ZYN NP, Rogue NP, usual SLT), Arm V (Rogue NP, usual SLT, ZYN NP), Arm VI (Rogue NP, ZYN NP, usual SLT)

Tobacco-Related Cancer Clinical Trial 2023: Nicotine Oral Pouch Highlights & Side Effects. Trial Name: NCT05730439 — Phase < 1

Nicotine Oral Pouch (Nicotine Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05730439 — Phase < 1

Frequently Asked Questions

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

Is this research opportunity currently open to participants?

"As indicated on clinicaltrials.gov, the recruitment phase of this medical trial has concluded. It was initially posted in April 1st 2023 and last updated February 14th 2023; however, there are 9 other trials currently enrolling patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Examining the Impact of Nicotine Pouches in Rural Ohio and Ohio Appalachia

Brittney Keller-Hamilton 2023. "Examining the Impact of Nicotine Pouches in Rural Ohio and Ohio Appalachia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05730439.