Electronic Cigarettes as a Harm Reduction Strategy Among People Living With HIV/AIDS
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2020
CompletedFirst Posted
Study publicly available on registry
January 6, 2020
CompletedStudy Start
First participant enrolled
June 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2024
CompletedDecember 20, 2024
October 1, 2024
2.5 years
January 2, 2020
December 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Assessing differences in nicotine withdrawal symptoms
Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)
Assessing differences in E-cigarette dependency
Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)
Assessing differences in nicotine use
Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)
Assessing differences in use of substance use
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
Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)
Study Arms (2)
counseling + nicotine replacement therapies NRT
ACTIVE COMPARATORA 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)
ACTIVE COMPARATORParticipants 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.
Interventions
Nicotine patch and gum will be given to subjects in the Nicotine replacement therapy cohort every visit after providing exhaled CO/Saliva cotinine test.
The MNWS assesses symptoms associated with nicotine withdrawal (i.e., craving, irritability, anxiety, difficulty concentrating, restlessness, increased appetite or weight gain, depression, and insomnia).
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).
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).
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Omar El Shahawy, MD
NYU Langone
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2020
First Posted
January 6, 2020
Study Start
June 17, 2021
Primary Completion
December 15, 2023
Study Completion
March 8, 2024
Last Updated
December 20, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).