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Very Low Nicotine Content Cigarettes for Nicotine Addiction

Phase 3

Waitlist Available

Led By Dorothy Hatsukami, PHD

Research Sponsored by University of Minnesota

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 7 days prior to end of phase 2 and the end of week 12 (12 weeks on study cigarettes)

Awards & highlights

Study Summary

This trial will compare how many cigarettes are smoked and how many days are cigarette-free when people have access to cigarettes with very low nicotine content, versus cigarettes with normal nicotine content.

Eligible Conditions

Nicotine Addiction
Tobacco Smoking

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days prior to end of phase 2 and the end of week 12 (12 weeks on study cigarettes)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days prior to end of phase 2 and the end of week 12 (12 weeks on study cigarettes)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days prior to end of phase 2 and the end of week 12 (12 weeks on study cigarettes) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Cigarettes Per Day (CPD)

Smoke-free Days

Secondary outcome measures

Percent Change in 2-cyanoethyl-mercapturic Acid (CEMA)

Seven-day Abstinence from Cigarettes

Study Cigarettes Per Day

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Very Low Nicotine Content CigarettesExperimental Treatment1 Intervention

Very low nicotine content cigarettes (0.4 mg/g nicotine; 9 mg of tar)

Group II: Normal Nicotine Content CigarettesActive Control1 Intervention

Normal (Conventional) Nicotine Content (15.8 mg/g nicotine; 9 mg of tar)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Very Low Nicotine Content Cigarettes

2018

Completed Phase 3

~1040

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Brown UniversityOTHER

456 Previous Clinical Trials

562,282 Total Patients Enrolled

Duke UniversityOTHER

2,356 Previous Clinical Trials

3,418,197 Total Patients Enrolled

3 Trials studying Nicotine Addiction

164 Patients Enrolled for Nicotine Addiction

University of PennsylvaniaOTHER

1,998 Previous Clinical Trials

42,878,582 Total Patients Enrolled

8 Trials studying Nicotine Addiction

1,955 Patients Enrolled for Nicotine Addiction

Frequently Asked Questions

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

Are there any other medical investigations that have been done with Very Low Nicotine Content Cigarettes?

"As of now, 74 clinical trials are underway studying the effects of Very Low Nicotine Content Cigarettes. Out of those, 5 are in Phase 3. The largest concentration of these studies is located in Green Bay, Wisconsin; however, there are a total 209 sites running these types of tests."

Answered by AI

Are patients being recruited for this clinical trial at the moment?

"No, this specific trial is no longer enrolling patients; however, there are other ongoing trials which might be of interest. For example, 149 clinical studies are currently recruiting participants who struggle with nicotine addiction and 74 different research projects are studying the effects of Very Low Nicotine Content Cigarettes."

Answered by AI

Do Very Low Nicotine Content Cigarettes put people at a higher risk for cancer?

"VLNC cigarettes have received a 3 for safety from our team at Power. This is due to the fact that this product is in Phase 3 of clinical trials, meaning that there are data supporting both efficacy and multiple rounds of safety testing."

Answered by AI

Are there many hospitals running this study in the urban area?

"There are 6 recruiting patients for this trial such as Center for Interdisciplinary Research on Nicotine Addiction in Philadelphia, Wake Forest Tobacco Control Center of Excellence in Winston-Salem, and Tobacco in Durham, along with other locations."

Answered by AI

Could you please tell me how many people are enrolled in this clinical trial?

"This particular study is no longer enrolling patients. The trial was first posted on June 1st, 2018 and received its most recent update on June 15th, 2022. However, there are other opportunities available; 149 active trials for nicotine dependence and 74 for Very Low Nicotine Content Cigarettes are still seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace

2018. "Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03272685.