Nicotine Replacement

Nicotine Replacement for Smokers

Prisma Health Cancer Institute - Easley, Easley, SC

Targeting 5 different conditionsNicotine Replacement +4 morePhase 2Waitlist AvailableLed by Elyse ParkResearch Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

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

Must have

Patient must be a current smoker. Current smoker is defined as any cigarette smoking (even a puff) in the past 30 days.

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 36 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Study Summary

This trial looks at how well cancer patients are able to quit smoking when given a smoking cessation treatment plan delivered online or over the phone.

Eligible Conditions

Current Smokers
Tumors
Cancer
Carcinoma

Eligibility Criteria

Inclusion Criteria

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

Select...

You have smoked any amount of cigarettes, even just a puff, within the past 30 days.

Select...

You have smoked a cigarette, even just one puff, within the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

7-day point-prevalence tobacco abstinence by saliva cotinine or expired air carbon monoxide (CO)

Secondary outcome measures

Cotinine

Self-reported 7-day point prevalence abstinence

Self-reported continuous tobacco abstinence

+1 more

Other outcome measures

Implementation of the intervention at community oncology sites

Intervention acceptability (satisfaction with content/delivery) at community oncology sites

Intervention adoption (program uptake) at community oncology sites

+8 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (virtual counseling sessions, NRT)Experimental Treatment4 Interventions

Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).

Group II: Arm A (smoking assessment, quitting advice, Quitline referral)Active Control2 Interventions

Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.

0 / 2Eligibility criteria met

Find a site

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor

111 Previous Clinical Trials

174,904 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,412 Previous Clinical Trials

41,238,486 Total Patients Enrolled

2 Trials studying Smokers

1,250 Patients Enrolled for Smokers

Elyse ParkPrincipal Investigator

ECOG-ACRIN Cancer Research Group

Media Library

Nicotine Replacement (Nicotine Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT03808818 — Phase 2

Smokers Research Study Groups: Arm A (smoking assessment, quitting advice, Quitline referral), Arm B (virtual counseling sessions, NRT)

Smokers Clinical Trial 2023: Nicotine Replacement Highlights & Side Effects. Trial Name: NCT03808818 — Phase 2

Nicotine Replacement (Nicotine Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03808818 — Phase 2

Frequently Asked Questions

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

How many participants are the researchers limiting this research to?

"This clinical trial requires 418 suitable participants. Those looking to take part can do so at the Prisma Health Cancer Institute - Spartanburg in South Carolina and/or the Prisma Health Cancer Institution - Butternut situated in Greenville, Minnesota."

Answered by AI

How many medical facilities have implemented this research?

"This clinical trial is presently open for enrollment at 38 medical sites. These locations are spread across Spartanburg, Greenville and Seneca as well as other cities around the United States of America. To reduce your travel commitment, it's important to select a site close by when enrolling."

Answered by AI

Has the FDA sanctioned any Nicotine Replacement therapies?

"Considering the Phase 2 status of this clinical trial, there is evidence to suggest nicotine replacement therapy's safety but no proof that it works. Therefore, we gave it a score of 2 on our scale from 1-3."

Answered by AI

Are there vacancies available for prospective test subjects in this experiment?

"According to information located on clinicaltrials.gov, this medical experiment is currently enrolling participants. Since its initial posting on April 11th 2019, it has been regularly updated as recently as November 15th 2022."

Answered by AI

Are there any prior investigations into Nicotine Replacement therapies?

"In 2006, the University of Hong Kong began studying nicotine replacement therapy. After 557 completed studies, there are presently 71 ongoing clinical trials across Spartanburg, South Carolina and beyond that focus on this particular area of research."

Answered by AI