Clinical trial NCT04218708: Electronic Cigarettes as a Harm Reduction Strategy Among People Living With HIV/AIDS
Official title: Electronic Cigarettes as a Harm Reduction Strategy Among People Living With HIV/AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Addiction
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Cigarettes per Day (CPD)
timeFrame: Visit 1 (week1), Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8), Visit 6 (week 12)
Secondary outcomes:
measure: Assessing differences in nicotine withdrawal symptoms
timeFrame: Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)
measure: Assessing differences in E-cigarette dependency
timeFrame: Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)
measure: Assessing differences in nicotine use
timeFrame: Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)
measure: Assessing differences in use of substance use
timeFrame: Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)
measure: Assessing differences in side effects associated with e-cigarette use
timeFrame: Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone
name: Omar El Shahawy, MD
role: PRINCIPAL_INVESTIGATOR
References: