Health effects of electronic cigarettes in smokers living with HIV
Health Effects of the Standardized Research E-Cigarette for Harm Reduction in Smokers With HIV
This study is testing if using electronic cigarettes can help HIV-positive smokers who aren't ready to quit feel better and change their smoking habits over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brown University Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT03862924 on ClinicalTrials.gov |
What this trial studies
This study investigates the health effects of using electronic cigarettes (ECs) as an alternative to traditional cigarettes among HIV-positive smokers who are not ready to quit smoking. It aims to assess the feasibility and acceptability of distributing ECs, the impact of EC use on smoking behaviors, and changes in cardiopulmonary symptoms and biomarkers over a 12-week period. Participants will be randomly assigned to either receive ECs or continue smoking their usual brand, with regular monitoring of their health and smoking habits. The study will also provide resources for smoking cessation at the end of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-positive individuals who smoke at least 5 cigarettes per day and are not planning to quit smoking in the next 30 days.
Not a fit: Patients who are actively seeking to quit smoking or are using other smoking cessation therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a viable harm reduction strategy for HIV-positive smokers, potentially improving their health outcomes.
How similar studies have performed: While some studies have shown that electronic cigarette use can increase confidence to quit smoking in the general population, this specific approach in HIV-positive smokers is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Providence, Rhode Island
- Brown University School of Public Health — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Principal investigator: PATRICIA A CIOE, PhD — Brown University
- Study coordinator: PATRICIA A CIOE, PhD
- Email: patricia_cioe@brown.edu
- Phone: 401-863-6638
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.