Health Effects of the Standardized Research E-Cigarette in Smokers With HIV Smokers With HIV

NCT03862924 | Recruiting DMC FDA Device

• 1 other identifier: 1U01DA045514
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Keywords

HIV; smoking

Outcome Measures

Primary Outcomes (1)

• Change in combustible cigarette use from baseline to 6 weeks

  Daily use of combustible cigarettes will be measured using the Timeline Followback method

  6 weeks

Secondary Outcomes (4)

• Change in Expired carbon monoxide (CO) level from baseline to 6 weeks

  6 weeks

• Change in serum biomarker levels from baseline to 6 weeks

  6 weeks

• Change in tobacco toxicant levels from baseline to 6 weeks

  6 weeks

• Change in Forced expiratory volume in 1 sec (FEV1) from baseline to 6 weeks

  6 weeks

Study Arms (2)

Active condition

EXPERIMENTAL

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.

Device: Standardized Research Electronic Cigarette

Standard Condition

NO INTERVENTION

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

Interventions

Standardized Research Electronic Cigarette DEVICE

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

Also known as: SREC

Active condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02912, United States

RECRUITING

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• PATRICIA A CIOE, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PATRICIA A CIOE, PhD

CONTACT

401-863-6638; patricia_cioe@brown.edu

Jasmine DiLorenzo, BA

CONTACT

401-863-6645; jasminette_dilorenzo@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Once the baseline interview is complete, the study coordinator, who is not involved in conducting assessments, will randomize eligible participants to either of two study conditions. A computerized urn randomization will be used to ensure the groups are balanced on gender and Fagerström Test of Cigarette Dependence (FTCD) score, (0-5 low; 6-10 high). Participants will be randomized to an active condition (in which they will be provided with the ECs) or the standard condition (in which they will continue to smoke their usual brand). All participants will receive a daily diary and will be asked to record daily how many CCs they smoke, how many EC cartridges they use, or any use of other tobacco products (i.e. cigars, cigarillos).

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 5, 2019
• Study Start: March 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

US (1)