Back to resultsElectronic Cigarettes as a Harm Reduction Strategy Among People Living With HIV/AIDS
Primary Purpose
Nicotine Addiction
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotine patch and gum
Minnesota Nicotine Withdrawal Scale (MNWS)
ASSIST (the Alcohol, Smoking and Substance Involvement Screening)
Counseling
NIDA Standardized Research E-cigarettes (SREC)
Sponsored by
About this trial
This is an interventional treatment trial for Nicotine Addiction
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.
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
counseling + nicotine replacement therapies NRT
Counseling + Standardized Research E-cigarettes (SREC)
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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" .
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)
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).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04218708
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 17, 2021 (Actual)
Primary Completion Date
November 18, 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Addiction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
counseling + nicotine replacement therapies NRT
Arm Type
Active Comparator
Arm 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.
Arm Title
Counseling + Standardized Research E-cigarettes (SREC)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Nicotine patch and gum
Intervention Description
Nicotine patch and gum will be given to subjects in the Nicotine replacement therapy cohort every visit after providing exhaled CO/Saliva cotinine test.
Intervention Type
Behavioral
Intervention Name(s)
Minnesota Nicotine Withdrawal Scale (MNWS)
Intervention Description
The MNWS assesses symptoms associated with nicotine withdrawal (i.e., craving, irritability, anxiety, difficulty concentrating, restlessness, increased appetite or weight gain, depression, and insomnia).
Intervention Type
Behavioral
Intervention Name(s)
ASSIST (the Alcohol, Smoking and Substance Involvement Screening)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
NIDA Standardized Research E-cigarettes (SREC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Cigarettes per Day (CPD)
Description
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.
Time Frame
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 Measure Information:
Title
Assessing differences in nicotine withdrawal symptoms
Description
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" .
Time Frame
Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)
Title
Assessing differences in E-cigarette dependency
Description
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)
Time Frame
Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)
Title
Assessing differences in nicotine use
Description
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).
Time Frame
Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)
Title
Assessing differences in use of substance use
Description
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.
Time Frame
Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)
Title
Assessing differences in side effects associated with e-cigarette use
Description
Will assess withdrawal symptoms using the acceptability through self reporting questionnaire regarding demographics and tobacco use and other medications.
Time Frame
Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar El Shahawy, MD
Organizational Affiliation
NYU Langone
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Electronic Cigarettes as a Harm Reduction Strategy Among People Living With HIV/AIDS
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