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Nicotine Replacement Therapy

Low-Nicotine Cigarettes for Heart Health (CEV Trial)

Q: Are there any unfilled vacancies available for participants in this clinical trial?

<p>As indicated on clinicaltrials.gov, this research trial is not seeking new participants at the moment; it was initially posted in April of 2023 and most recently updated at the end of January 2023. Although this study isn't currently recruiting, there are over fifty other studies actively searching for volunteers now.</p>

Q: What are the intended outcomes of this research endeavor?

<p>This trial's primary objective, which requires an evaluative period of roughly one hour, is to measure the change in heart rate when exposed to Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine). Secondary analyses include assessing changes in Heart Rate Variability (HRV) for both VLNCC and Normal Nicotine Content Cigarettes (NNCC)s as well as evaluating electrocardiogram measures like Q-T interval, QTc &#x26; Tp-e intervals after exposure with 0.5 mg nicotine cigarettes.</p>

Phase < 1

Recruiting

Led By Eric C Donny, PhD

Research Sponsored by Wake Forest University Health Sciences

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 hour 1

Awards & highlights

CEV Trial Summary

This trial is looking at how cigarettes with low nicotine affect the heart of both daily and non-daily smokers.

Who is the study for?

This trial is for adults over 21 who smoke cigarettes at least once a month, can understand English well enough for study procedures, and are willing to smoke either very low nicotine content cigarettes or their usual brand during the lab visit. It's not for those trying to quit smoking, with recent cardiovascular diseases, high body temperature, thyroid disorders, pregnant or breastfeeding women, or unstable health conditions affecting ECG readings.Check my eligibility

What is being tested?

The study investigates the cardiovascular effects of 'SPECTRUM' cigarettes which have very low nicotine content compared to smokers' usual brands. Daily and non-daily smokers will participate in lab visits where they'll smoke these research cigarettes to see how they affect heart health.See study design

What are the potential side effects?

While specific side effects aren't listed here as it's an observational study on cardiovascular effects rather than a drug trial, potential risks may include typical smoking-related side effects such as increased heart rate and blood pressure changes.

CEV Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ hour 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~hour 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and hour 1 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Heart rate - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)

Change in Heart rate - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)

Change in Heart rate - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine)

Secondary outcome measures

Change in Heart rate variability(HRV) - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)

Change in Heart rate variability(HRV) - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)

Change in Heart rate variability(HRV) - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine)

+3 more

CEV Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Research Cigarettes (SPECTRUM)Experimental Treatment1 Intervention

Participants will smoke 1-2 SPECTRUM cigarettes

Group II: Usual Brand of CigarettesActive Control1 Intervention

Participants will smoke 2-3 cigarettes of their usual brand

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SPECTRUM cigarettes

2017

N/A

~310

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,242 Previous Clinical Trials

1,004,242 Total Patients Enrolled

3 Trials studying Tobacco Use

40,754 Patients Enrolled for Tobacco Use

Eric C Donny, PhDPrincipal InvestigatorWake Forest University Health Sciences

2 Previous Clinical Trials

839 Total Patients Enrolled

1 Trials studying Tobacco Use

Media Library

SPECTRUM cigarettes (Nicotine Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05707871 — Phase < 1

Tobacco Use Clinical Trial 2023: SPECTRUM cigarettes Highlights & Side Effects. Trial Name: NCT05707871 — Phase < 1

SPECTRUM cigarettes (Nicotine Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05707871 — Phase < 1

Frequently Asked Questions

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

Are there any unfilled vacancies available for participants in this clinical trial?

"As indicated on clinicaltrials.gov, this research trial is not seeking new participants at the moment; it was initially posted in April of 2023 and most recently updated at the end of January 2023. Although this study isn't currently recruiting, there are over fifty other studies actively searching for volunteers now."

Answered by AI

What are the intended outcomes of this research endeavor?

"This trial's primary objective, which requires an evaluative period of roughly one hour, is to measure the change in heart rate when exposed to Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine). Secondary analyses include assessing changes in Heart Rate Variability (HRV) for both VLNCC and Normal Nicotine Content Cigarettes (NNCC)s as well as evaluating electrocardiogram measures like Q-T interval, QTc & Tp-e intervals after exposure with 0.5 mg nicotine cigarettes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cardiovascular Effects of Very Low Nicotine Content Cigarettes

2023. "Cardiovascular Effects of Very Low Nicotine Content Cigarettes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05707871.