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OpenTrials
Completed

NCT Number: NCT04525755

STARS (Smoking Treatment And Remote Sampling) Study

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.

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Key information

Conditions

Smoking Behavior Cigarette Smoking Health Behavior Smoking Cessation Tobacco Smoking Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varenicline 0.5 MG

Drug

varenicline comes in bottles of 56 - 0.5 mg pills

Other names: Chantix, Varenicline Pill

Nicotine replacement therapy (NRT)

Drug

28 day supply of nicotine patch (1 patch x 28 days @ 14 mg) and lozenge (14 per day x 28 days @ 4 mg)

Other names: NRT Sampling, Nicotine Patches and Lozenges, Nicotine Replacement Therapy Sampling, NRT

Primary outcomes

  1. Smoking Cessation

    Time frame: At six-month follow up

    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

Secondary outcomes

  1. Reduction in Smoking

    Time frame: At the week 4 and week 26 follow up follow up

    Percentage of participants who have reduced 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

  2. Any Quit Attempts

    Time frame: From study enrollment through end of six-month follow up (cumulative percent over six months)

    Any self-defined attempt and any 24-hr quit attempt to stop smoking cigarettes among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group

  3. Use of Smoking Cessation Medication

    Time frame: At 4 and 24 week follow-up

    Use of either varenicline or NRT (patch or lozenge) among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 25, 2020
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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