Recruiting

E-Cigarette

Sponsor:

Brown University

Code:

NCT03862924

Conditions

HIV

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standardized Research Electronic Cigarette

Study Details

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.

Conditions

HIV

Study ID

NCT03862924

Start date

Mar 1, 2022

Status verified date

Jun, 2024

Completion date

Dec 30, 2024

Anticipated

Primary completion date

Apr 30, 2024

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Active condition

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.

no intervention: Standard Condition

Participants in this condition will be asked to continue to smoke their usual brand of cigarettes.

Interventions

Standardized Research Electronic Cigarette

Participants will receive SREC weekly and eill be encouraged to replace their usual combustible cigarette with the SREC whenever they would normally smoke.

Primary outcome measure

  • Change in combustible cigarette use from baseline to 6 weeks [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

Brown University School of Public Health

Recruiting

Providence, Rhode Island, United States, 02912

Contacts

More Information

Sponsor

Brown University

Last update posted

Jun 18, 2024

Last verified

Jun, 2024

Keywords

  • HIV
  • smoking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brown University on 2024-06-18.