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Behavioural Intervention

Nicotine Metabolite Ratio for Smoking Cessation (QUIT Trial)

N/A

Recruiting

Led By Georgia J Michlig, PhD

Research Sponsored by Southcentral Foundation

Eligibility Criteria Checklist

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

Must have

Age 18 years or older

Be older than 18 years old

Must not have

Has bleeding disorder or is currently receiving cancer treatment

Their provider has not approved varenicline in their referral to the Quit Tobacco Program

Timeline

Screening 3 weeks

Treatment Varies

Follow Up beta phase (n=10) 6 weeks; pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new intervention that uses the Nicotine Metabolite Ratio to help choose the best medication for helping Alaska Native and American Indian people quit smoking. It is a small trial to

Who is the study for?

This trial is for Alaska Native and American Indian individuals who are looking to quit smoking. Participants should be interested in using a personalized approach based on their body's metabolism of nicotine to select the best treatment.

What is being tested?

The study is testing an intervention that uses the Nicotine Metabolite Ratio (NMR) to choose the most suitable pharmacologic treatment aimed at helping participants stop smoking. It's a single-arm pilot trial focusing on how acceptable and doable this method is.

What are the potential side effects?

Since specific side effects aren't listed, they may vary depending on the chosen pharmacologic treatments after assessing each participant's NMR. Common quitting aids can cause mood swings, cravings, or physical reactions like headaches.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a bleeding disorder or am currently undergoing cancer treatment.

Select...

My doctor did not approve varenicline for my Quit Tobacco Program.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ beta phase (n=10) 6 weeks; pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~beta phase (n=10) 6 weeks; pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and beta phase (n=10) 6 weeks; pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of metabolism-informed intervention: Qualitative

Acceptability of metabolism-informed intervention: Quantitative

Feasibility of intervention implementation: Enrollment

+2 more

Secondary study objectives

Smoking Cessation: Expelled CO

Smoking Cessation: Nicotine <10ng/mL

Smoking Cessation: Self-report

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nicotine Metabolite RatioExperimental Treatment1 Intervention

Subjects identified as cigarette smokers wishing to quit will receive the Nicotine Metabolite Ratio (NMR) test in a primary care setting and the results of the NMR will be used to inform medication recommendations for tobacco cessation.

0 / 3Eligibility criteria met