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

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.

Conditions

• Nicotine Addiction

Interventions

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).

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.

Sponsors & Collaborators

• NYU Langone Health

  lead OTHER

Principal Investigators

• Omar El Shahawy, MD · NYU Langone

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-17

Primary Completion

2023-12-15

Completion

2024-03-08

Countries

• United States

Study Locations