Health Effects of the Standardized Research E-Cigarette in Smokers With HIV Smokers With HIV
Part of paid clinical trials in Providence, Rhode Island.
- Sponsor
- Brown University
- Study ID
- NCT03862924
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Standardized Research Electronic Cigarette — DEVICEParticipants will receive SREC weekly and eill be encouraged to replace their usual combustible cigarette with the SREC whenever they would normally smoke.
Study Details
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.
Key Dates
- Start date
- Mar 1, 2022
- Status verified
- Jun 2024
- Primary completion
- Apr 30, 2024
- Completion
- Dec 30, 2024
Study Design
- Enrollment
- 72 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: Active conditionParticipants 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.
- No Intervention: Standard ConditionParticipants in this condition will be asked to continue to smoke their usual brand of cigarettes.
Primary Outcome Measure
Change in combustible cigarette use from baseline to 6 weeks [ Time Frame: 6 weeks ]
Central Contacts
- PATRICIA A CIOE, PhD401-863-6638
- Jasmine DiLorenzo, BA401-863-6645
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Brown University School of Public Health | Providence | Rhode Island | 02912 |
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