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SREC + Nicotine Lozenge for Smoking Cessation

Phase 1
Recruiting
Led By Irina Stepanov, PhD
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women who are not pregnant or nursing or planning to become pregnant
Report smoking ≥ 5 cigarettes daily and not using any other nicotine or tobacco product
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing a government-made e-cigarette to see how toxic and carcinogenic it is. The goal is to see if e-cigarettes can help reduce tobacco risks.

Who is the study for?
This trial is for adult smokers aged 18-65 who smoke more than 5 cigarettes daily, have been smoking for at least a year, and haven't tried to quit in the last 3 months. Participants must be in good physical and mental health, not use other tobacco or nicotine products, and agree to switch completely to e-cigarettes or nicotine lozenges. Pregnant women or those on certain medications are excluded.Check my eligibility
What is being tested?
The study tests the toxic and carcinogenic potential of a Standardized Research E-cigarette (SREC) compared with Nicotine Mini-Lozenge. It aims to provide reference data on chemical exposures when regular smokers switch from traditional cigarettes to SRECs or medicinal nicotine.See study design
What are the potential side effects?
Potential side effects may include irritation from propylene glycol or vegetable glycerin found in e-cigarettes, typical reactions associated with quitting smoking such as cravings, mood swings, headaches, fatigue, coughing and digestive changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant, nursing, or planning to become pregnant.
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I smoke 5 or more cigarettes daily and don't use other tobacco products.
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I am over 18 and have agreed to participate in this study.
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I am not on anti-inflammatory drugs or meds that affect metabolism.
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I am a smoker aged 18-65 and willing to switch to e-cigarettes or nicotine replacement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Exposure Biomarkers
Formaldehyde-DNA adducts
NNN-derived HPB-releasing DNA adducts
+2 more
Secondary outcome measures
Cigarette Avoidance
Product Use

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Switching from Smoking Cigarettes to SRECExperimental Treatment1 Intervention
Group II: Switching from Smoking Cigarettes to Nicotine Mini-LozengeExperimental Treatment1 Intervention
Group III: Usual Brand CigarettesActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine Mini-Lozenge
2015
Completed Phase 4
~580

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,468 Previous Clinical Trials
2,619,223 Total Patients Enrolled
Masonic Cancer Center, University of MinnesotaLead Sponsor
271 Previous Clinical Trials
14,500 Total Patients Enrolled
Irina Stepanov, PhDPrincipal InvestigatorUniversity of Minnesota, Division of Environmental Health Sciences
2 Previous Clinical Trials
91 Total Patients Enrolled

Media Library

Standardized Research E-cigarette (SREC) Clinical Trial Eligibility Overview. Trial Name: NCT04003805 — Phase 1
Smoking/Cigarette Smoking Research Study Groups: Switching from Smoking Cigarettes to SREC, Usual Brand Cigarettes, Switching from Smoking Cigarettes to Nicotine Mini-Lozenge
Smoking/Cigarette Smoking Clinical Trial 2023: Standardized Research E-cigarette (SREC) Highlights & Side Effects. Trial Name: NCT04003805 — Phase 1
Standardized Research E-cigarette (SREC) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04003805 — Phase 1

Frequently Asked Questions

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

What is the aggregate number of participants involved in this medical experiment?

"Affirmative. According to data hosted on clinicaltrials.gov, this medical study is currently seeking out participants after being posted for the first time on May 11th 2022 and edited most recently on November 2nd 2022. 125 patients need to be recruited from 1 trial site."

Answered by AI

Am I eligible to join this research endeavor?

"To be accepted into this clinical study, candidates must have a smoking habit and are expected to fall within the age bracket of 18 to 65 years old. Around 125 participants will be enrolled in total."

Answered by AI

Are there any potential hazards to using Standardized Research E-cigarette (SREC)?

"The safety profile of Standardized Research E-cigarette (SREC) has been evaluated as a 1 due to the observational nature of this Phase 1 trial and its lack of efficacy data."

Answered by AI

Is this research still seeking participants?

"Affirmative. Clinicaltrials.gov attests that this research is actively seeking out volunteers, having first been published on May 11th 2022 and most recently revised on November 2nd 2022. This trial necessitates the enlistment of 125 participants from a single medical centre."

Answered by AI

Can you provide an overview of past research conducted with the Standardized Research E-cigarette (SREC)?

"Presently, 71 clinical trials are underway examining the efficacy of Standardized Research E-cigarette (SREC), with 5 studies in Phase 3. Green Bay, Wisconsin is a hub for SREC research; however, there are 204 separate sites currently conducting examinations on this product."

Answered by AI

Does this research accept participants aged sixty and over?

"This research initiative is open to individuals over the age of majority and below 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Alabama
Minnesota
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~10 spots leftby Jul 2024