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Electronic Cigarettes
E-Cigarettes vs Nicotine Replacement for Smoking in HIV/AIDS Patients
N/A
Waitlist Available
Led By Omar El Shahawy, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Current Combustible Cigarette (CC) smokers (more than 5 packs in a lifetime; smokes 4 or more days/week)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 1 (week1), visit 2 (week 2), visit 3 (week 4), visit 4 (week 6), visit 5 (week 8), visit 6 (week 12)
Awards & highlights
Study Summary
This trial will test if e-cigarettes are more effective than nicotine replacement therapy in reducing cigarette smoking for adults with HIV/AIDS.
Who is the study for?
This trial is for adults living with HIV/AIDS in New York City who smoke cigarettes regularly (at least 10 per day) and are motivated to quit. Participants must be able to consent, agree to randomization and follow-up, and willing to use e-cigarettes or nicotine replacement therapy for 12 weeks. Pregnant or breastfeeding individuals, those with certain medical conditions like heart disease, untreated psychiatric illnesses, or severe lung diseases cannot join.Check my eligibility
What is being tested?
The study aims to compare the effectiveness of electronic cigarettes against traditional nicotine replacement therapies (like patches and gum) in helping people living with HIV/AIDS reduce cigarette smoking. It involves assessments using ASSIST screening, Minnesota Nicotine Withdrawal Scale (MNWS), counseling support, and monitoring through follow-ups.See study design
What are the potential side effects?
Potential side effects may include irritation from the nicotine patch or gum such as skin redness or itching at the application site. E-cigarette use can lead to throat irritation or coughing. Both methods might cause nausea, headaches, sleep disturbances or increased blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I currently smoke cigarettes regularly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 1 (week1), visit 2 (week 2), visit 3 (week 4), visit 4 (week 6), visit 5 (week 8), visit 6 (week 12)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 1 (week1), visit 2 (week 2), visit 3 (week 4), visit 4 (week 6), visit 5 (week 8), visit 6 (week 12)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Cigarettes per Day (CPD)
Secondary outcome measures
Alcoholic Intoxication, Chronic
Assessing differences in nicotine use
Assessing differences in nicotine withdrawal symptoms
+2 moreTrial Design
2Treatment groups
Active Control
Group I: counseling + nicotine replacement therapies NRTActive Control4 Interventions
A research assistant (RA) trained in motivational interviewing and qualitative methods will support the PI to deliver counseling sessions and conduct interviews. Briefly, during each visit, with help of the RA, participants will provide exhaled CO and saliva cotinine test, and complete surveys in REDCAP using a tablet, allowing programmed logic checks and skip patterns to minimize burden. The RA will also deliver brief motivational counseling tailored to the participant's readiness to quit and arm in the study (NRT). Participants will also receive their NRT to last them to the following visit based on their baseline smoking.
Group II: Counseling + Standardized Research E-cigarettes (SREC)Active Control4 Interventions
Participants in the SREC arm to practice using the SREC and give them instructions to return with their SREC and used refill tanks on every visit. A research assistant (RA) trained in motivational interviewing and qualitative methods will support the PI to deliver counseling sessions and conduct interviews. Briefly, during each visit, with help of the RA, participants will provide exhaled CO and saliva cotinine test, and complete surveys in REDCAP using a tablet, allowing programmed logic checks and skip patterns to minimize burden. The RA will also deliver brief motivational counseling tailored to the participant's readiness to quit and arm in the study (SREC). Participants will also receive their SREC to last them to the following visit based on their baseline smoking.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,657 Total Patients Enrolled
Omar El Shahawy, MDPrincipal InvestigatorNYU Langone
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe or untreated heart or lung conditions like asthma or emphysema.I currently smoke cigarettes regularly.I do not have heart conditions that prevent me from using nicotine patches or gum.I am willing to use an e-cigarette or nicotine replacement therapy for 12 weeks.I am not currently being treated for any psychiatric illness or cognitive impairment.You have used nicotine replacement therapy, e-cigarettes, or any other nicotine products within the past 30 days.You smoke at least 10 cigarettes per day on days when you smoke.I am motivated to quit smoking.
Research Study Groups:
This trial has the following groups:- Group 1: counseling + nicotine replacement therapies NRT
- Group 2: Counseling + Standardized Research E-cigarettes (SREC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies available for participants in this experiment?
"Affirmative. According to the information available via clinicaltrials.gov, this trial is actively recruiting patients and has been since June 17th 2021; with the last update taking place on October 5th 2022. The protocol calls for 120 people to be enrolled at a single site."
Answered by AI
Would I meet the requirements to partake in this research endeavor?
"The criteria to be eligible for this medical study entails being aged 18-65 and having contracted acquired immunodeficiency syndrome. This specific trial is recruiting a maximum of 120 individuals."
Answered by AI
What is the limit for participants in this clinical trial?
"Affirmative, according to clinicaltrials.gov this research venture is actively searching for participants. The trial began on June 17th 2021 and was most recently amended on October 5th 2022. Researchers are hoping to enrol 120 people from 1 site."
Answered by AI
Are there any previous experiments that have combined counseling and nicotine replacement therapies?
"Currently, 71 trials researching the combination of counselling and nicotine replacement therapies (NRT) are running. Of those studies, 5 have reached Phase 3. While many of these experiments are based in Augusta, Georgia there are 204 sites where one can access this type of treatment."
Answered by AI
Is the eligibility criteria restricted to those aged 65 or above for this medical experiment?
"Participants between the ages of 18 to 65 are eligible for this medical research. However, there is a further 117 trials catering to those younger than 18 and 483 available for seniors over 65 years old."
Answered by AI
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