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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nicotine Addiction
• Intervention / Treatment: 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)

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: counseling + nicotine replacement therapies NRT; 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.	Other: Nicotine patch and gum; Nicotine patch and gum will be given to subjects in the Nicotine replacement therapy cohort every visit after providing exhaled CO/Saliva cotinine test.; Behavioral: Minnesota Nicotine Withdrawal Scale (MNWS); The MNWS assesses symptoms associated with nicotine withdrawal (i.e., craving, irritability, anxiety, difficulty concentrating, restlessness, increased appetite or weight gain, depression, and insomnia).; Behavioral: ASSIST (the Alcohol, Smoking and Substance Involvement Screening); The ASSIST is the Alcohol, Smoking and Substance Involvement Screening Test. It is a brief screening questionnaire to find out about people's use of psychoactive substances (alcohol, smoking and substance involvement).; Behavioral: Counseling; At each study visit, participants will receive counseling protocol that will be based on effective counseling manuals. The PI will train the research assistant who will assist the PI in tailoring the manual to the target group: counseling will cover health education, social support issues, and motivational enhancement to improve self-efficacy while addressing other aspects known to contribute to smoking among PLWHA (e.g., tips on dealing with depression and feeling stigmatized particularly in relation to HIV).
Active Comparator: Counseling + 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.	Behavioral: Minnesota Nicotine Withdrawal Scale (MNWS); The MNWS assesses symptoms associated with nicotine withdrawal (i.e., craving, irritability, anxiety, difficulty concentrating, restlessness, increased appetite or weight gain, depression, and insomnia).; Behavioral: ASSIST (the Alcohol, Smoking and Substance Involvement Screening); The ASSIST is the Alcohol, Smoking and Substance Involvement Screening Test. It is a brief screening questionnaire to find out about people's use of psychoactive substances (alcohol, smoking and substance involvement).; Behavioral: Counseling; At each study visit, participants will receive counseling protocol that will be based on effective counseling manuals. The PI will train the research assistant who will assist the PI in tailoring the manual to the target group: counseling will cover health education, social support issues, and motivational enhancement to improve self-efficacy while addressing other aspects known to contribute to smoking among PLWHA (e.g., tips on dealing with depression and feeling stigmatized particularly in relation to HIV).; Other: NIDA Standardized Research E-cigarettes (SREC); NIDA SREC has a case with a liquid tank. The e-liquid is supplied in sealed disposable cartridges that deliver >300 puffs / cartridge. The SREC uses a battery recharged via a micro USB port. A single charge is designed to outlast the capacity of an e-liquid cartridge. The e-liquid is "tobacco" flavored and contains nicotine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cigarettes per Day (CPD)	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.	Visit 1 (week1), Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8), Visit 6 (week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing differences in nicotine withdrawal symptoms	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" .	Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)
Assessing differences in E-cigarette dependency	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)	Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)
Assessing differences in nicotine use	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).	Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)
Assessing differences in use of substance use	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.	Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)
Assessing differences in side effects associated with e-cigarette use	Will assess withdrawal symptoms using the acceptability through self reporting questionnaire regarding demographics and tobacco use and other medications.	Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Omar El Shahawy, MD, NYU Langone

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 19-01179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to omar.elshahawy@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No