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DOSE-UP: Dose Optimization for Smoking and E-Cigarette Use Pharmacotherapy

NCT07754578 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2026-08-11

No results posted yet for this study

Summary

This randomized clinical trial evaluates the effectiveness of augmented-dose combination nicotine replacement therapy (NRT) versus standard-dose NRT and no-NRT control for cessation of dual combustible cigarette (CC) and electronic cigarette (EC) use. Adults who currently engage in dual use and are motivated to quit both products will be assigned to one of three 12-week interventions: (1) no pharmacotherapy (behavioral support only), (2) standard-dose NRT (21 mg nicotine patch + 4 mg lozenges, 5-20/day), or (3) augmented-dose NRT (21 mg + 14 mg patches + 4 mg lozenges, 5-30/day). All groups receive evidence-based behavioral support through the EX Program. Primary outcomes include biochemically confirmed dual abstinence and CC-only abstinence at 12 and 24 weeks. A subset of participants will provide blood and saliva samples to assess DNA damage biomarkers associated with tobacco use and cessation.

Conditions

  • Dual Use of Cigarettes and E-cigarettes

Interventions

BEHAVIORAL

Text- and web-based support

Participants will enroll in the Ex Program for support in quitting smoking and vaping.

DRUG

Nicotine Replacement Therapy (NRT, nicotine patch)

21mg patch

DRUG

Nicotine Replacement Therapy (NRT, nicotine patch)

21mg + 14mg patch

DRUG

Nicotine replacement therapy lozenge

4mg; 5-20/day

DRUG

Nicotine replacement therapy lozenge

4mg; 5-30/day

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-10
Primary Completion
2030-04-10
Completion
2031-07-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07754578 on ClinicalTrials.gov