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Nicotine Replacement Therapy

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

Phase 2

Recruiting

Led By Amanda Palmer

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18yrs +

Daily nicotine-containing e-cigarette user (25+ days per previous month)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 28, day 56

Awards & highlights

CAN-DOSE Trial Summary

This trial looks at how using nicotine patches and lozenges can help people quit smoking and vaping. It also tests if higher doses work better.

Who is the study for?

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.Check my eligibility

What is being tested?

This 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.See study design

What are the potential side effects?

Possible side effects from the nicotine patch and lozenge include skin irritation at the patch site, sleep problems, headache, nausea, dizziness, racing heartbeat, muscle pain or stiffness.

CAN-DOSE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I use nicotine e-cigarettes daily.

CAN-DOSE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 28, day 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 28, day 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28, day 56 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Days of dual use abstinence

Secondary outcome measures

Feasibility/Acceptability

Reduction

Safety

CAN-DOSE Trial Design

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]

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

American Cancer Society, Inc.OTHER

224 Previous Clinical Trials

110,410 Total Patients Enrolled

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,591 Total Patients Enrolled

Amanda PalmerPrincipal InvestigatorMedical University of South Carolina

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks have been identified for participants in Arm A?

"Our assessment of the safety of Arm A is 2, due to it being a Phase 2 trial. This means there is information confirming its security but no data promoting its efficacy."

Answered by AI

Are there any vacancies in the research study for participants?

"As per details on clinicaltrials.gov, this particular medical experiment is not presently seeking out individuals to participate in the study. First posted on November 1st 2023 and edited lastly October 12th of the same year, it is among 193 other trials actively recruiting patients currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CAN-DOSE Study: Cessation With Augmented Nicotine for Dual Use Of Smoking and E-cigarettes

Amanda Palmer, PhD 2023. "CAN-DOSE Study: Cessation With Augmented Nicotine for Dual Use Of Smoking and E-cigarettes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06087328.