STARS (Smoking Treatment And Remote Sampling) Study

Study Overview
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Brief Summary
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This is a research study to find out if a smoking cessation medications, either varenicline or nicotine replacement products (patches or lozenges), are effective when given to smokers, remotely, as a one-time sample. Participants will either receive a sample of varenicline, nicotine patches and lozenges, or neither. This will be decided randomly. Participants have a 50%chance of receiving varenicline, a 25% chance of receiving nicotine products, and a 25% chance of receiving neither. If the participant is assigned to a group that receives free samples, they will be mailed to them free of charge. There is no requirement to use them, and it is completely up to the participants. There is also no requirement to quit in this study. The study lasts for six months, and will involve six total surveys. In addition, investigators ask that participants complete daily diaries (about 1 minute each) for the first 4 weeks of the study. Both varenicline and nicotine replacement products are well-established medications that help smokers quit.

Official Title
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A Translational Randomized Clinical Trial of Varenicline Sampling to Promote Smoking Cessation and Scalable Treatment Dissemination

Conditions
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Smoking, Smoking Cessation, Tobacco Smoking, Cigarette Smoking

Intervention / Treatment
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* Drug: Varenicline 0.5 MG
* Drug: Nicotine Replacement Therapy (NRT)


Participation Criteria
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Eligibility Criteria
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Eligibility criteria include: age 18+; daily smoker (25+ days per previous month); smoking 5+ cigarettes/day; smoking > 1yr; some interest in eventual quitting (>2 on 10-point scale); has a primary care doctor and has seen that doctor at least once in past year; not currently pregnant, breastfeeding, or planning to become pregnant; no suicidal ideation in past month, nor any lifetime suicide attempt; no reports of hallucinations; no reports of history of seizures; nor cardiac/renal disease own a smartphone or have regular (daily) access/use of email if female, willing to take a pregnancy test not currently taking any medications to help quit smoking no diagnosis of schizophrenia or bipolar disorder no members of the same household currently enrolled in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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. 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. 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Varenicline (.5mg BID)<br>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. | Drug: Varenicline 0.5 MG<br>* varenicline comes in bottles of 56 - 0.5 mg pills<br>* Other names: Varenicline Pill;|
| Active Comparator: Nicotine Replacement Therapy (NRT)<br>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. | Drug: Nicotine Replacement Therapy (NRT)<br>* 28 day supply of nicotine patch (1 patch x 28 days @ 14 mg) and lozenge (14 per day x 28 days @ 4 mg)<br>* Other names: NRT;|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day Quit Attempts | Percentage of participants With 7-day self-reported point prevalence abstinence, among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group | From study enrollment through end of six-month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Smoking | Percentage of participants who have reduces their smoking by at least 50%, at both Week 4 and Week 26 follow-up, among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group | At the week 4 follow up and week 26 follow up. | 
| Any Quit Attempts | Any self-defined attempt to stop smoking cigarettes among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group | From study enrollment through end of six-month follow up | 
| Use of Smoking Cessation Medication | Use of any smoking cessation medication among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group | From study enrollment through end of six-month follow up |