NCT03862924Recruiting
Health Effects of the Standardized Research E-Cigarette in Smokers With HIV Smokers With HIV
Health Effects of the Standardized Research E-Cigarette for Harm Reduction in Smokers With HIV
Source: ClinicalTrials.gov · Last updated 18 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 27 Feb 2019
- Start date
- 1 Mar 2022
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- Brown University
- Diseases
- HIV
- NCT number
- NCT03862924
What you commit to
- Study type: Interventional
- Planned participants: 72
- From 1 Mar 2022 to the primary completion date, 30 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- currently using pharmacotherapy for smoking cessation
- currently using electronic cigarettes more than 2 days/week
Other illness
- unstable medical or psychiatric condition (defined as hospitalization)
- medical contraindications to nicotine (unstable angina, uncontrolled hypertension, or recent cardiovascular event, including hospitalization)
- substance use disorder other than nicotine dependence
Other
- intention to quit smoking in the next 30 days
- psychotic symptoms
- past-month suicidal ideation or past-year suicide attempt
- pregnant or nursing.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brown University School of Public Health Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.