NCT06169813 is a Phase 1 clinical trial of Nicotine Replacement Therapy (NRT) in Tobacco Smoking, sponsored by NYU Langone Health.

Who is sponsoring NCT06169813?

NCT06169813 is sponsored by NYU Langone Health.

What drugs are being tested in NCT06169813?

Interventions in NCT06169813: Nicotine Replacement Therapy (NRT), E-Cigarette (EC), Counseling.

What condition does NCT06169813 study?

NCT06169813 studies Tobacco Smoking.

Is NCT06169813 still recruiting?

NCT06169813 is currently active, enrolled. Last updated 3 November 2025.

Last reviewed 2025-11-03 · How we verify

NCT06169813

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

E-cigarette Harm Reduction Among PLWHA in South Africa

Active, enrolled Phase 1 Last updated 3 November 2025

What this trial tests

Phase 1 trial testing Nicotine Replacement Therapy (NRT) in Tobacco Smoking in 106 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 April 2025

Primary endpoint
24 October 2025

27 February 2026

Quick facts

Lead sponsor	NYU Langone Health
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	106
Start date	15 April 2025
Primary completion	24 October 2025
Estimated completion	27 February 2026
Sites	1 location across South Africa

Drugs / interventions tested

Nicotine Replacement Therapy (NRT) (nicotine-replacement-therapy-nrt) — full drug profile →
E-Cigarette (EC)
Counseling

Conditions studied

Tobacco Smoking — all drugs for Tobacco Smoking →

Sponsor

NYU Langone Health — full company profile →

Who can join

Adults 18 to 70, any sex, with Tobacco Smoking. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this pilot randomized controlled trial study aims to address the unmet need for feasible and efficacious strategies for reducing combustible cigarette (CC) use among people living with HIV/AIDS (PLWHA) in South Africa, which has the potential to significantly improve the health and long-term survival of PLWHA CC smokers. Using the proposed intervention, based on the Information-Motivation-Behavioral Skills (IMB), and a simultaneous embedded mixed methods approach, the investigators will evaluate a telehealth program targeting CC harm reduction, comparing E-cigarettes (EC) to nicotine replacement therapy (NRT) that is enhanced by integrating ecological momentary intervention (EMI) texting. As such, this proposal will significantly build research capacity in South Africa to conduct telehealth tobacco treatment interventions using innovative EMI approaches enhancing participants' engagement, as well as state-of-the art evaluation approaches.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Electronic cigarettes for smoking cessation.
Lindson N, Butler AR, McRobbie H, Bullen C, et al · · 2025 · cited 32× · PMID 39878158 · DOI 10.1002/14651858.cd010216.pub9

Verify or expand the search:

Other trials of Nicotine Replacement Therapy (NRT)

Trials testing the same drug.

NCT07148232 — Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness · Phase 4 · recruiting
NCT06127589 — The "Quit-for-Kids" Project: to Increase Abstinence and Protect Children from Tobacco Smoke Exposure · NA · recruiting
NCT04126135 — Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy · Phase 4 · completed
NCT04899492 — Evaluation of Different Smoking Cessation Protocols: Nicotine Replacement, Motivational Interviewing (MI), Cognitive Beh · NA · terminated
NCT04525755 — STARS (Smoking Treatment And Remote Sampling) Study · Phase 1, PHASE2 · completed

Other recruiting trials for Tobacco Smoking

Currently open trials in the same condition.

NCT07398443 — Using Novel Behavioral Economic Measures to Characterize Dual Marijuana and Tobacco Use in Young Adults · NA · recruiting
NCT07132814 — Abuse Liability for Five Modern Oral Nicotine Products · NA · recruiting
NCT07129590 — Trauma-Informed Care for Smoking Cessation for Pregnancy · NA · recruiting
NCT07039175 — Intervention to Increase Intention to Change Alcohol/Tobacco Use in Veterans With Chronic Disease · Phase 3 · recruiting
NCT07236580 — Buteyko Breathing and Approach of Smoking Hygiene: Effects on Dysfucntion of Eustachian Tube and Lung Functions · NA · recruiting

Other NYU Langone Health trials

Trials by the same sponsor.

NCT07214519 — Permanent Supportive Housing Overdose Prevention-2 Study · NA · not yet recruiting
NCT05558267 — Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease · NA · not yet recruiting
NCT06637852 — Sexual and Urinary Function Improvement for Cancer Survivors · NA · not yet recruiting
NCT06236087 — Overdose Prevention Centers and Behavioral Health · not yet recruiting
NCT06462027 — Packed Red Blood Cell Transfusion During Cardiac Arrest · Phase 1 · suspended

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06169813 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
Last refreshed: 3 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06169813.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing