STARS (Smoking Treatment And Remote Sampling) Study

NCT ID: NCT04525755

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 652 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-08
• Study Completion Date: 2025-04-05

Brief 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.

Conditions

Smoking; Smoking Cessation; Tobacco Smoking; Cigarette Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Varenicline (.5mg BID)

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 Type: EXPERIMENTAL

Varenicline 0.5 MG

Intervention Type: DRUG

varenicline comes in bottles of 56 - 0.5 mg pills

Nicotine Replacement Therapy (NRT)

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 Type: ACTIVE_COMPARATOR

Nicotine Replacement Therapy (NRT)

Intervention Type: DRUG

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

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Varenicline 0.5 MG

varenicline comes in bottles of 56 - 0.5 mg pills

Intervention Type: DRUG

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)

Intervention Type: DRUG

Other Intervention Names

Chantix; Varenicline Pill; NRT Sampling; Nicotine Patches and Lozenges; Nicotine Replacement Therapy Sampling; NRT

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Matthew Carpenter

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00098479

Identifier Type: -

Identifier Source: org_study_id