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

Not Applicable

Completed

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

• Registration Number: NCT04218708
• Lead Sponsor: NYU Langone Health

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-02
• Study First Submitted QC: 2020-01-03
• Study First Posted: 2020-01-06
• Study Start: 2021-06-17
• Primary Completion: 2023-12-15
• Study Completion: 2024-03-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
counseling + nicotine replacement therapies NRT	Minnesota Nicotine Withdrawal Scale (MNWS)	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.
counseling + nicotine replacement therapies NRT	Counseling	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.
Counseling + Standardized Research E-cigarettes (SREC)	ASSIST (the Alcohol, Smoking and Substance Involvement Screening)	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.
Counseling + Standardized Research E-cigarettes (SREC)	Counseling	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.
counseling + nicotine replacement therapies NRT	Nicotine patch and gum	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.
counseling + nicotine replacement therapies NRT	ASSIST (the Alcohol, Smoking and Substance Involvement Screening)	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.
Counseling + Standardized Research E-cigarettes (SREC)	NIDA Standardized Research E-cigarettes (SREC)	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.
Counseling + Standardized Research E-cigarettes (SREC)	Minnesota Nicotine Withdrawal Scale (MNWS)	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.

Primary Outcome Measures

Name	Time	Method
Change in Cigarettes per Day (CPD)	Visit 1 (week1), Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8), Visit 6 (week 12)	In the e-cigarette arm, participants will be encouraged to substitute SREC (15 mg/ml nicotine in tobacco flavor) for CC in order to reduce nicotine withdrawal symptoms. Smoking reduction will be measured by a combination of self-report, text message data and changes in CO and saliva cotinine between baseline and end of treatment.

Secondary Outcome Measures

Name	Time	Method
Assessing differences in E-cigarette dependency	Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)	Will assess withdrawal symptoms of E-cigarette dependency using potential side effects of NRT/SREC using the E-cigarette Dependence Index (SREC arm). 9 questions assess the experience with Electronic cigarettes to gauge how depend the subjects are on e-cigarettes (0 - 3 = not dependent, 4 - 8 low dependence, 9 - 12 medium dependence, 13+ = high dependence)
Assessing differences in nicotine withdrawal symptoms	Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)	Will assess withdrawal symptoms of nicotine using the Minnesota Nicotine Withdrawal Scale (MNWS). The 9 item scale which assess withdrawal symptoms will be rated on a 5 point scale "not present", " slight", "mild", "moderate" and "severe" .
Assessing differences in nicotine use	Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)	Will assess withdrawal symptoms using smoking cessation self-efficacy using the Smoking Self-efficacy Questionnaire: SEQ-12. The 12 item questionnaire assess how people refrain form smoking in certain situations using a 5 point Likert scale (1=not at all sure, 2=not very sure, 3=more or less, 4=fairly sure, 5= absolutely sure).
Assessing differences in side effects associated with e-cigarette use	Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)	Will assess withdrawal symptoms using the acceptability through self reporting questionnaire regarding demographics and tobacco use and other medications.
Assessing differences in use of substance use	Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)	Will assess withdrawal symptoms using the acceptability through ASSIST screening tool (the Alcohol, Smoking and Substance Involvement Screening). 8 questions asking about the experience of using substances across the subjects lifetime and in the past 3 months.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States