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Nicotine Replacement Therapy
Varenicline + NRT for Smoking Cessation in PLWHA (HTO Trial)
Phase 3
Recruiting
Led By Robert Schnoll, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
>18 years
>18 years, smoke daily for the past 30 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
HTO Trial Summary
This trial will test the efficacy of varenicline, in combination with nicotine replacement therapy (NRT), compared to varenicline alone, for smoking cessation among PLWHA.
Who is the study for?
This trial is for adults over 18 who smoke daily, live near the study sites for at least 7 months, and can safely use varenicline or nicotine patches. Participants must be HIV positive with a viral load under 1000 copies/mL. Those with recent serious health issues, certain mental health conditions, or using other tobacco cessation methods cannot join.Check my eligibility
What is being tested?
The study tests if adding Managed Problem Solving (MAPS) to standard treatment helps people living with HIV/AIDS quit smoking more effectively than just standard care alone. It also examines the effectiveness of Varenicline and nicotine patches in this specific group.See study design
What are the potential side effects?
Possible side effects include skin reactions from the patch, nausea, sleep problems, mood changes from Varenicline or MAPS intervention. The severity of side effects may vary among individuals.
HTO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 years old.
Select...
I am over 18 and have smoked daily for the last 30 days.
HTO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Point-prevalence abstinence
Secondary outcome measures
Continuous abstinence
Prolonged abstinence
Six-month quit rate
+1 moreHTO Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NMR-Tailored Medication & Standard Cessation Counseling + MAPSExperimental Treatment3 Interventions
varenicline or nicotine patch plus standard behavioral smoking cessation treatment with Managed Problem Solving adherence intervention
Group II: Varenicline & Standard Cessation CounselingActive Control2 Interventions
varenicline plus standard behavioral smoking cessation treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline
2011
Completed Phase 4
~4170
Nicotine patch
2015
Completed Phase 4
~7450
Find a Location
Who is running the clinical trial?
Northwestern UniversityOTHER
1,585 Previous Clinical Trials
916,891 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,002 Previous Clinical Trials
42,880,659 Total Patients Enrolled
8 Trials studying Nicotine Addiction
1,955 Patients Enrolled for Nicotine Addiction
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,923,994 Total Patients Enrolled
1 Trials studying Nicotine Addiction
20 Patients Enrolled for Nicotine Addiction
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 years old.My high blood pressure is not under control.I have had cancer, heart disease, stroke, or a heart attack in the last 6 months and need approval from the study doctor.I do not have untreated major depression, psychosis, or bipolar disorder.You use electronic cigarettes, chewing tobacco, snuff or snus.You are currently struggling with drug or alcohol addiction and are not receiving treatment for it.You are currently enrolled in a program to quit smoking.You are living in the geographic area close to one of the sites for at least 7 months.You have HIV and your viral load is less than 1000 copies/mL.I'm sorry, I cannot summarize or rewrite this criterion without additional context. Can you please provide more information?I can safely use varenicline or a nicotine patch.You have smoked every day for the last month.I am over 18 and have smoked daily for the last 30 days.I have widespread eczema or psoriasis.
Research Study Groups:
This trial has the following groups:- Group 1: Varenicline & Standard Cessation Counseling
- Group 2: NMR-Tailored Medication & Standard Cessation Counseling + MAPS
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Nicotine Addiction Patient Testimony for trial: Trial Name: NCT04176172 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the risks associated with the Standard treatment + Managed Problem Solving (MAPS) adherence intervention for people?
"Standard treatment + Managed Problem Solving (MAPS) adherence intervention received a score of 3 for safety. This is due to the Phase 3 trial status, which means that there is some data supporting efficacy and multiple rounds of data supporting safety."
Answered by AI
Are there other instances where a similar treatment to Standard treatment + Managed Problem Solving (MAPS) has been effective?
"The Standard treatment + Managed Problem Solving (MAPS) adherence intervention was first trialled in 2006 at The University of Hong Kong. As of now, 599 such trials have been completed with 92 more currently recruiting patients. Many of these active trials are based out of Chicago, Illinois."
Answered by AI
What does the Standard treatment + Managed Problem Solving (MAPS) adherence intervention usually target?
"Standard treatment combined with the Managed Problem Solving adherence intervention can help patients that are struggling with conditions such as smoke, dry eye syndromes, and nicotine addiction."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
New Jersey
Illinois
How old are they?
18 - 65
What site did they apply to?
Northwestern University
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
Because I would to stop smoking.
PatientReceived no prior treatments
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