STARS (Smoking Treatment And Remote Sampling) Study

Last updated on July 2021

Recruitment

Recruitment Status: Recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Cigarette Smoking
Smoking
Smoking Cessation
Tobacco Smoking

Type

Interventional

Phase

Phase 1Phase 2

Design

Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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)Primary Purpose: Prevention

Participation Requirements

Age: Between 18 years and 125 years
Gender: Both males and females

Description

Not Provided

Tracking Information

NCT #: NCT04525755
Collaborators: Not Provided
Investigators: Not Provided