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E-Cigarettes for HIV/AIDS (ProjectSREC Trial)

N/A

Recruiting

Led By PATRICIA A 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

smoke at least 5 cigarettes per day for longer than one year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

ProjectSREC Trial Summary

This trial will explore if switching to e-cigarettes can reduce health risks in HIV+ smokers who can't quit.

Who is the study for?

This trial is for HIV-positive adults who have been under care for the condition, are at least 18 years old, and have smoked more than 5 cigarettes daily for over a year. They must also show a certain level of carbon monoxide in their breath.Check my eligibility

What is being tested?

The study is testing if using standardized research electronic cigarettes (e-cigarettes) can help HIV-positive smokers reduce or quit smoking regular cigarettes, and what effects this switch has on heart and lung health.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include throat irritation, coughing, dry mouth or increased nicotine dependence due to e-cigarette use.

ProjectSREC Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

I have been smoking more than 5 cigarettes daily for over a year.

ProjectSREC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in combustible cigarette use from baseline to 6 weeks

Secondary outcome measures

Change in Expired carbon monoxide (CO) level from baseline to 6 weeks

Change in Forced expiratory volume in 1 sec (FEV1) from baseline to 6 weeks

Change in serum biomarker levels from baseline to 6 weeks

+1 more

ProjectSREC Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Active conditionExperimental Treatment1 Intervention

Participants in the active condition will be provided with the Standardized Research Electronic Cigarette (SREC) and will be encouraged to use the SREC whenever they would normally smoke a cigarette.

Group II: Standard ConditionActive Control1 Intervention

Participants in this condition will be asked to continue to smoke their usual brand of cigarettes.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor

456 Previous Clinical Trials

558,212 Total Patients Enrolled

PATRICIA A CIOE, PhDPrincipal InvestigatorBrown University

Media Library

Active condition Clinical Trial Eligibility Overview. Trial Name: NCT03862924 — N/A

HIV/AIDS Research Study Groups: Standard Condition, Active condition

HIV/AIDS Clinical Trial 2023: Active condition Highlights & Side Effects. Trial Name: NCT03862924 — N/A

Active condition 2023 Treatment Timeline for Medical Study. Trial Name: NCT03862924 — N/A

Frequently Asked Questions

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

Could you provide the aggregate number of participants in this investigation?

"Affirmative. Per the information housed on clinicaltrials.gov, this research project is currently recruiting volunteers and was initially posted on March 1st 2022. The study has been updated as recently April 21st 2023 and requires 72 participants from a single medical centre."

Answered by AI

Are new participants still being added to this research endeavor?

"According to clinicaltrials.gov, this medical investigation is actively recruiting subjects; the trial was uploaded on March 1st 2022 and its details were most recently revised on April 21st 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Health Effects of the Standardized Research E-Cigarette in Smokers With HIV Smokers With HIV

Patricia Cioe 2022. "Health Effects of the Standardized Research E-Cigarette in Smokers With HIV Smokers With HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03862924.