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Very Low Nicotine Cigarettes for Smoking Cessation (ENHANCE Trial)

N/A
Recruiting
Led By Amy Cohn, PhD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18 to 34
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (visit 1) to week 9
Awards & highlights

ENHANCE Trial Summary

This trial will study how young smokers perceive and act when smoking cigarettes with little to no nicotine. They will also study a sub-sample of LGBTQ2S+ smokers.

Who is the study for?
This trial is for young adult smokers aged 18 to 26 who can read English at an eighth-grade level or higher. Participants should smoke cigarettes 'somedays' or 'everyday,' with a strong preference for menthol, and no immediate plans to quit. Those pregnant, breastfeeding, with significant heart disease, hypertension, other smoking-related diseases, serious psychiatric disorders, a preference for non-menthol cigarettes, or using nicotine replacement therapy cannot join.Check my eligibility
What is being tested?
The study is testing very low nicotine cigarettes among young adults who prefer menthol. It aims to understand their perceptions and smoking behaviors both in controlled lab settings and in everyday life. A specific focus will be on the LGBTQ2S+ community within this group.See study design
What are the potential side effects?
While not explicitly stated here, potential side effects may include typical reactions associated with reduced nicotine intake such as cravings, irritability, anxiety, difficulty concentrating and increased appetite.

ENHANCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 34 years old.

ENHANCE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (visit 1) to week 9
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (visit 1) to week 9 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 Cigarette Evaluation Scale (CES)
Change in puff topography
Hypothetical Purchasing of Tobacco Products
Secondary outcome measures
Change in CO boost
Other outcome measures
Blood pressure
Drop-out rate
Heart rate
+4 more

ENHANCE Trial Design

2Treatment groups
Experimental Treatment
Group I: Non-menthol very low nicotine cigaretteExperimental Treatment1 Intervention
Participants will smoke non-menthol flavored very low nicotine cigarettes in their home environment for 7 days. At the end of 7-days, they will also smoke one non-menthol flavored very low nicotine cigarette in the laboratory.
Group II: Menthol very low nicotine cigaretteExperimental Treatment1 Intervention
Participants will smoke menthol flavored very low nicotine cigarettes in their home environment for 7 days. At the end of 7-days, they will also smoke one menthol flavored very low nicotine cigarette in the laboratory.

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
455 Previous Clinical Trials
98,041 Total Patients Enrolled
4 Trials studying Smoking
143 Patients Enrolled for Smoking
Amy Cohn, PhDPrincipal InvestigatorUniversity of Oklahoma
1 Previous Clinical Trials
190 Total Patients Enrolled

Media Library

Very low nicotine cigarettes (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04340947 — N/A
Smoking Research Study Groups: Menthol very low nicotine cigarette, Non-menthol very low nicotine cigarette
Smoking Clinical Trial 2023: Very low nicotine cigarettes Highlights & Side Effects. Trial Name: NCT04340947 — N/A
Very low nicotine cigarettes (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04340947 — N/A

Frequently Asked Questions

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

Is this investigation targeting individuals aged 55 or older?

"Eligible individuals for this research must be aged between 18 to 26; however, there are two additional trials available to those below the age of majority and 43 trials open to senior citizens."

Answered by AI

What is the cap on enrolment for this clinical trial?

"Affirmative. The clinicaltrials.gov website suggests that recruitment for this medical trial is accelerating, with its initial posting on September 1st 2021 and latest edit on April 11th 2022. This research requires 132 individuals to be enrolled from 2 institutions."

Answered by AI

Are there still open positions for participants in this experiment?

"Affirmative. Clinicaltrials.gov presents evidence that this trial, posted on September 1st 2021 and updated April 11th 2022, is searching for 132 volunteers across two sites."

Answered by AI

Who meets the criteria to become a part of this medical investigation?

"This medical experiment is open to individuals aged 18-26 who have expressed a preference for smoking menthol cigarettes with an 8th grade or higher proficiency in English. In addition, they must smoke at least daily or some days over the last 3 months and cannot presently plan on ceasing their habit. 132 participants total are being enrolled."

Answered by AI

Who else is applying?

What site did they apply to?
Health Promotion Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I've tried well butrin and chantyx and once I stopped the medication the desire returned.
PatientReceived no prior treatments
~48 spots leftby Oct 2024