NCT03862924 Health Effects of the Standardized Research E-Cigarette in Smokers With HIV Smokers With HIV
| NCT ID | NCT03862924 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brown University |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2024-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2022-03-01 with a primary completion date of 2024-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cigarette smoking is more prevalent (50-70%) in persons living with HIV in the U.S. when compared with the general population and is linked to increased rates of heart disease, lung diseases and infections, and lung cancers. Because of their high levels of nicotine dependence, low quit rates, and familiarity with harm reduction, HIV-positive smokers may view the use of alternative nicotine delivery products, such as electronic cigarettes (ECs), as an attractive option for reducing and eventually stopping combustible cigarette use. However, little is known about the health effects of electronic cigarette use in HIV-positive smokers. Some studies have shown that electronic cigarette use was associated with increased confidence to quit smoking in the general population. The primary objectives of this project are to examine whether HIV-positive smokers, who are unwilling or unable to quit smoking, will substitute an electronic cigarette for regular cigarettes, and to examine whether there are any changes in heart and lung health in HIV-positive smokers who switch from regular cigarettes to electronic cigarettes.
Eligibility Criteria
Inclusion Criteria: * diagnosed with and engaged in care for HIV (defined as at least one HIV clinic medical appointment within the past six month period) * at least 18 years of age * smoke at least 5 cigarettes per day for longer than one year * exhaled carbon monoxide (CO) level greater than 5 at BL Exclusion Criteria: * intention to quit smoking in the next 30 days * currently using pharmacotherapy for smoking cessation * currently using electronic cigarettes more than 2 days/week * unstable medical or psychiatric condition (defined as hospitalization) * medical contraindications to nicotine (unstable angina, uncontrolled hypertension, or recent cardiovascular event, including hospitalization) * psychotic symptoms * substance use disorder other than nicotine dependence * past-month suicidal ideation or past-year suicide attempt * pregnant or nursing.
Contact & Investigator
PATRICIA A CIOE, PhD
PRINCIPAL INVESTIGATOR
Brown University
Frequently Asked Questions
Who can join the NCT03862924 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03862924 currently recruiting?
Yes, NCT03862924 is actively recruiting participants. Contact the research team at patricia_cioe@brown.edu for enrollment information.
Where is the NCT03862924 trial being conducted?
This trial is being conducted at Providence, United States.
Who is sponsoring the NCT03862924 clinical trial?
NCT03862924 is sponsored by Brown University. The principal investigator is PATRICIA A CIOE, PhD at Brown University. The trial plans to enroll 72 participants.
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