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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

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
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I have been smoking more than 5 cigarettes daily for over a year.

Timeline

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

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.

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor
459 Previous Clinical Trials
559,285 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
~22 spots leftby Jul 2025