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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
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).
NYU Langone Health
New York, New York, United States
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.
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)
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" .
Time frame: 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)
Time frame: 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).
Time frame: Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)
Assessing differences in use of substance use
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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.
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)
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.
Time frame: Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8)