STARS (Smoking Treatment And Remote Sampling) Study

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04525755
• Other study ID #: Pro00098479
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 8, 2021
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: Medical University of South Carolina
• Contact: Amy Boatright
• Phone: 843-876-2440
• Email: boatrigh[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 648
• Est. completion date: September 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Eligibility criteria include:

1. age 18+;

2. daily smoker (25+ days per previous month);

3. smoking 5+ cigarettes/day;

4. smoking > 1yr;

5. some interest in eventual quitting (>2 on 10-point scale);

6. has a primary care doctor and has seen that doctor at least once in past year;

7. not currently pregnant, breastfeeding, or planning to become pregnant;

8. no suicidal ideation in past month, nor any lifetime suicide attempt;

9. no reports of hallucinations;

10. no reports of history of seizures; nor cardiac/renal disease

11. own a smartphone or have regular (daily) access/use of email

12. if female, willing to take a pregnancy test

13. not currently taking any medications to help quit smoking

14. no diagnosis of schizophrenia or bipolar disorder

15. no members of the same household currently enrolled in the study

Related Conditions & MeSH terms

• Cigarette Smoking
• Smoking
• Smoking Cessation
• Tobacco Smoking

Intervention

Drug:
• Varenicline 0.5 MG
varenicline comes in bottles of 56 - 0.5 mg pills
• Nicotine Replacement Therapy (NRT)
28 day supply of nicotine patch (1 patch x 28 days @ 14 mg) and lozenge (14 per day x 28 days @ 4 mg)

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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