Electronic Cigarettes as a Harm Reduction Strategy Among People Living With HIV/AIDS

NYU Langone Health

Status: Completed

Conditions: Nicotine Addiction

Treatments: Behavioral: ASSIST (the Alcohol, Smoking and Substance Involvement Screening); Behavioral: Counseling; Behavioral: Minnesota Nicotine Withdrawal Scale (MNWS); Other: NIDA Standardized Research E-cigarettes (SREC); Other: Nicotine patch and gum

Study type: Interventional

Funder types: Other

Identifiers

NCT04218708

19-01179

Details and patient eligibility

About

This is a research study to understand and determine the effectiveness of electronic cigarettes versus nicotine replacement therapy in adults who smoke and also live with HIV/AIDS in effort to reduce cigarette smoking.

Full description

People living with HIV/AIDS (PLWHA) are known to have exceptionally higher rate of cigarette smoking and very low quit rates compared to the general population. Although a primary rationale for conducting this study is reducing health disparities among PLWHA, there is a potential benefit of the proposed work from a prevention perspective given that combustible cigarette smoking is an independent risk factor for non-adherence to ART and may decrease the effectiveness of HAART. Smoking-related illnesses are leading causes of non-HIV/AIDS-related deaths among People Living with HIV/AIDS (PLWHA). Electronic cigarettes (E-cigarettes) could help people reduce the harm of combustible cigarette (CC) through reductions in number of Cigarettes per Day (CPD) or quitting CC completely by addressing both nicotine and behavioral dependence. Unlike CC, EC are not associated with coronary heart disease or myocardial infarction. The purpose is to identify barriers and facilitators, as well as assess preliminary effectiveness of e-cigarettes as a harm reduction strategy among PLWHA.

Enrollment: 64 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current Combustible Cigarette (CC) smokers (more than 5 packs in a lifetime; smokes 4 or more days/week),
• Smokes at least 10 cigarettes per day on days they smoke CC.
• Motivated to quit smoking (at least a 5 on a 10-point Likert scale).
• Must be able to provide consent
• Agree to be randomized and followed-up with,
• Reside in New York City
• Be willing to use an e-cigarette or NRT for 12 weeks.

Exclusion criteria

• Are pregnant (as determined by urine test) or breastfeeding (self-reported),
• State diagnosis of any medical condition (angina/heart disease) precluding use of nicotine patch or gum, or by self-report in screening questionnaire
• Reporting using NRTs or e-cigarettes or within the last 30 days
• Have untreated/are undergoing current treatment for psychiatric illness or cognitive impairment at time of initial screening as determined by the subjects' primary care doctor or a licensed study team member in screening
• Report a history of severe or untreated cardiopulmonary disease such as asthma or emphysema.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

counseling + nicotine replacement therapies NRT

Active Comparator group

Description:

A research assistant (RA) trained in motivational interviewing and qualitative methods will support the PI to deliver counseling sessions and conduct interviews. Briefly, during each visit, with help of the RA, participants will provide exhaled CO and saliva cotinine test, and complete surveys in REDCAP using a tablet, allowing programmed logic checks and skip patterns to minimize burden. The RA will also deliver brief motivational counseling tailored to the participant's readiness to quit and arm in the study (NRT). Participants will also receive their NRT to last them to the following visit based on their baseline smoking.

Treatment:

Other: Nicotine patch and gum

Behavioral: Minnesota Nicotine Withdrawal Scale (MNWS)

Behavioral: Counseling

Behavioral: ASSIST (the Alcohol, Smoking and Substance Involvement Screening)

Counseling + Standardized Research E-cigarettes (SREC)

Active Comparator group

Description:

Participants in the SREC arm to practice using the SREC and give them instructions to return with their SREC and used refill tanks on every visit. A research assistant (RA) trained in motivational interviewing and qualitative methods will support the PI to deliver counseling sessions and conduct interviews. Briefly, during each visit, with help of the RA, participants will provide exhaled CO and saliva cotinine test, and complete surveys in REDCAP using a tablet, allowing programmed logic checks and skip patterns to minimize burden. The RA will also deliver brief motivational counseling tailored to the participant's readiness to quit and arm in the study (SREC). Participants will also receive their SREC to last them to the following visit based on their baseline smoking.

Treatment:

Other: NIDA Standardized Research E-cigarettes (SREC)

Behavioral: Minnesota Nicotine Withdrawal Scale (MNWS)

Behavioral: Counseling

Behavioral: ASSIST (the Alcohol, Smoking and Substance Involvement Screening)