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Smoking Cessation Medications for Quitting Smoking

Phase 1 & 2

Waitlist Available

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

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

Must have

no reports of hallucinations

no diagnosis of schizophrenia or bipolar disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from study enrollment through end of six-month follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether giving smokers free samples of smoking cessation medications, either varenicline or nicotine replacement products, is an effective way to help them quit.

Who is the study for?

The STARS study is for adult smokers who have smoked more than a year, smoke at least 5 cigarettes daily, and are somewhat interested in quitting. They must have seen their primary care doctor within the past year, not be pregnant or breastfeeding, and should not have a history of seizures or severe mental health issues like schizophrenia.

What is being tested?

This trial tests if one-time samples of smoking cessation medications (varenicline or nicotine patches/lozenges) sent remotely can help smokers quit. Participants will randomly receive varenicline, nicotine products, or no treatment. The study involves surveys over six months and daily diaries for the first month.

What are the potential side effects?

Varenicline may cause nausea, sleep disturbances, mood changes, and headaches. Nicotine replacement therapy can lead to skin irritation from patches or mouth issues from lozenges; both might cause dizziness or racing heartbeat.

Eligibility Criteria

Inclusion Criteria

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

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I have not experienced hallucinations.

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I have not been diagnosed with schizophrenia or bipolar disorder.

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I have never had seizures, heart, or kidney diseases.

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I have not had thoughts of suicide in the last month and have never attempted suicide.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from study enrollment through end of six-month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from study enrollment through end of six-month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and from study enrollment through end of six-month follow up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

7-day Quit Attempts

Secondary study objectives

Any Quit Attempts

Reduction in Smoking

Use of Smoking Cessation Medication

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Varenicline (.5mg BID)Experimental Treatment1 Intervention

Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline (.5 mg, 60 tablets total), NRT, or not, with outcomes assessed through 12 weeks of follow-up. 324 participants will be enrolled in this group. Participants in the varenicline sampling group will be given standard instructions on titration but ultimately will decide on their own as to if and how it is used. Dosing is lower than most industry trials of varenicline (1mg BID) but consistent with two trials of lower dosing that showed efficacy and with fewer side effects. Varenicline participants can choose to titrate 2mg if they wish, with shorter duration of sampling experience.

Group II: Nicotine Replacement Therapy (NRT)Active Control1 Intervention

Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. 162 participants will be enrolled in this group. Participants in NRT group will receive 28 day supply of nicotine patch (1patch x 28 days @ 14mg) and lozenge (14 per day x 28 days @4mg) with instructions to use based on number of cigarettes smoked per day. Like varenicline participants, smokers in NRT group can use as much or as little of the NRT as they wish.

Group III: Control GroupActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Varenicline 0.5 MG

2018

Completed Early Phase 1

~100

0 / 4Eligibility criteria met