Nicotine Replacement Therapy

Nicoderm CQ 21Mg/24Hr Transdermal System for Quitting Smoking

Brown University School of Public Health, Providence, RI
Nicoderm CQ 21Mg/24Hr Transdermal SystemPhase 2 & 3RecruitingLed by Patricia Cioe, PhDResearch Sponsored by Brown University

Study Summary

This trial is testing if starting nicotine replacement therapy (NRT) earlier than usual may help smokers who are struggling with dependence, cravings, and low confidence to quit successfully. Sixty participants will be randomly assigned to either the control group (standard NRT counseling) or the active group (starting NRT 3 weeks before quit date). The investigators will examine differences in quit attempts and biochemically validated smoking abstinence between the two groups at weeks 8, 12, and 16.

Eligible Conditions
  • Quitting Smoking

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You smoke at least 5 cigarettes per day.
You are okay with using a nicotine patch that goes on your skin.
You are willing to stop the behavior being studied within the next 30 days.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
adherence to NRT
Secondary outcome measures
7 day point prevalence abstinence

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PreloadingExperimental Treatment1 Intervention
Participants will be started on nicotine patch 3 weeks prior to quit date. At quit date they will use patch and lozenge or gum for 8 weeks.
Group II: Standard treatmentActive Control1 Intervention
Participants will start combination nicotine replacement therapy (patch/gum or patch/lozenge) on their assigned quit date. NRT will be provided for 8 weeks.

Find a site

Who is running the clinical trial?

Brown UniversityLead Sponsor
442 Previous Clinical Trials
525,808 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,412 Previous Clinical Trials
41,239,006 Total Patients Enrolled
2 Trials studying Quitting Smoking
13,098 Patients Enrolled for Quitting Smoking
Patricia Cioe, PhDPrincipal Investigator
Brown University School of Public Health

Media Library

Nicoderm CQ 21Mg/24Hr Transdermal System (Nicotine Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04994444 — Phase 2 & 3
Quitting Smoking Research Study Groups: Preloading, Standard treatment
Quitting Smoking Clinical Trial 2023: Nicoderm CQ 21Mg/24Hr Transdermal System Highlights & Side Effects. Trial Name: NCT04994444 — Phase 2 & 3
Nicoderm CQ 21Mg/24Hr Transdermal System (Nicotine Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04994444 — Phase 2 & 3
Quitting Smoking Patient Testimony for trial: Trial Name: NCT04994444 — Phase 2 & 3

Frequently Asked Questions

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

Are there other examples of similar medical trials using Nicoderm CQ 21Mg/24Hr Transdermal System?

"Currently, there are 74 clinical trials underway for Nicoderm CQ 21Mg/24Hr Transdermal System. Of these studies, 5 are in Phase 3. Most of the research being done on Nicoderm CQ 21Mg/24Hr Transdermal System is happening Green Bay, Wisconsin; however, 209 other locations across the world are also conducting trials."

Answered by AI

Who else is applying?

What state do they live in?
New York
Rhode Island
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
What site did they apply to?
Brown University School of Public Health

Why did patients apply to this trial?

I've tried g and everything else. I need to quit smoking I have been smoking 43 years.
I really want to quit smoking and I think the patches would help.

How responsive is this trial?

Most responsive sites:
  1. Brown University School of Public Health: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
~4 spots leftby Dec 2023