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Nicotine Replacement Therapy

Nicotine Preloading for Quitting Smoking

Phase 2 & 3
Recruiting
Led By Patricia Cioe, PhD
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age
Diagnosed with HIV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights

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.

Who is the study for?
This trial is for HIV-positive adults who smoke at least 5 cigarettes a day, have an exhaled carbon monoxide level over 5, and are ready to quit smoking within the next month. It's not for those already on smoking cessation drugs, with recent medical or psychiatric instability, experiencing psychosis or suicidal thoughts, or who are pregnant/nursing.Check my eligibility
What is being tested?
The study tests if starting nicotine patches (Nicoderm CQ) three weeks before quitting helps more than beginning them on the quit date. Both groups also get counseling and can choose gum or lozenges after quitting. The goal is to see which method better reduces cigarette cravings and increases confidence in quitting.See study design
What are the potential side effects?
Possible side effects of Nicoderm CQ include skin irritation where the patch is applied, dizziness, headache, upset stomach or vomiting, diarrhea or constipation, increased appetite leading to weight gain.

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 have been diagnosed with HIV.

Timeline

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

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 Location

Who is running the clinical trial?

Brown UniversityLead Sponsor
454 Previous Clinical Trials
562,751 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,281 Total Patients Enrolled
2 Trials studying Quitting Smoking
13,098 Patients Enrolled for Quitting Smoking
Patricia Cioe, PhDPrincipal InvestigatorBrown 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?
Massachusetts
New York
Other
Rhode Island
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
0
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. Want to quit.plus need some financial help aswell.
PatientReceived 1 prior treatment
I need to quit smoking I have been smoking 43 years. I really want to quit smoking and I think the patches would help.
PatientReceived 2+ prior treatments
I am 62 and have been trying to quit SMOKING for the past 10yrs UNSUCCESSFULLY.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Brown University School of Public Health: < 48 hours
Typically responds via
Phone Call
~17 spots leftby Mar 2025