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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

No Placebo-Only Group

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.

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.

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

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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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in combustible cigarette use from baseline to 6 weeks

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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