Nicotine Replacement Therapy for Smoking Cessation
(CAN-DOSE Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAmanda Palmer

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Medical University of South Carolina

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests if nicotine patches and lozenges can help people who both smoke and vape to quit. It compares different doses to see which works best. The goal is to find an effective way to help dual users stop using tobacco products. Nicotine patches and lozenges have been studied extensively as aids to help people stop smoking, with various studies indicating their potential effectiveness.

Research Team

Amanda Palmer

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

The CAN-DOSE study is for adults over 18 who use nicotine e-cigarettes daily and smoke cigarettes weekly, wanting to quit both within a month. They must be willing to use nicotine replacement therapy (NRT) and have no medical conditions that make NRT unsafe, like recent heart issues or pregnancy.

Inclusion Criteria

E-cigarette use 5+ times/day

Mailing address in SC.

Willingness to use NRT

See 6 more

Exclusion Criteria

I do not have heart issues, uncontrolled vascular disease, or conditions affected by phenylalanine.

Individuals reporting current use of other nicotine-containing products and/or smoking cessation medications

Those who vape non-nicotine substances

See 1 more

Treatment Details

Interventions

Augmented Nicotine patch and lozenge dose (Nicotine Replacement Therapy)
Regular Nicotine patch and lozenge dose (Nicotine Replacement Therapy)

Trial OverviewThis study tests whether using nicotine patches and lozenges can help people stop smoking and vaping. It compares the effectiveness of regular versus higher doses of these medications in aiding cessation.

Participant Groups

3Treatment groups

Active Control

Group I: Arm AActive Control1 Intervention

21mg patch, qd + 4mg lozenge prn \[minimum of 5 \& up to 20 per day\]

Group II: Arm BActive Control1 Intervention

21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 \& \[up to 30 per day\]

Group III: Arm CActive Control1 Intervention

2 x 21mg patches qd + 4mg lozenges prn \[minimum of 5 \& up to 40 per day\]