NCT03559725 is a Phase 1 clinical trial of VLN menthol cigarettes (A) in Tobacco Use, sponsored by 22nd Century Group, Inc..

Who is sponsoring NCT03559725?

NCT03559725 is sponsored by 22nd Century Group, Inc..

What drugs are being tested in NCT03559725?

Interventions in NCT03559725: VLN menthol cigarettes (A), Usual Brand Menthol Cigarettes (B), Nicotine gum (C).

What condition does NCT03559725 study?

NCT03559725 studies Tobacco Use.

Is NCT03559725 still recruiting?

NCT03559725 is currently completed. Last updated 25 March 2020.

Last reviewed 2020-03-25 · How we verify

NCT03559725

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

Evaluation of Abuse Liability of Very Low Nicotine (VLN) Mentholated Cigarettes

Completed Phase 1 Last updated 25 March 2020

What this trial tests

Phase 1 trial testing VLN menthol cigarettes (A) in Tobacco Use in 55 participants. Completed in 4 October 2018.

Timeline

1 May 2018

Primary endpoint
4 October 2018

4 October 2018

Quick facts

Lead sponsor	22nd Century Group, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	55
Start date	1 May 2018
Primary completion	4 October 2018
Estimated completion	4 October 2018
Sites	1 location across United States

Drugs / interventions tested

VLN menthol cigarettes (A)
Usual Brand Menthol Cigarettes (B)
Nicotine gum (C) — full drug profile →

Conditions studied

Tobacco Use — all drugs for Tobacco Use →

Sponsor

22nd Century Group, Inc. — full company profile →

Who can join

Adults 22 to 65, any sex, with Tobacco Use. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is designed to evaluate the abuse liability of mentholated very low nicotine cigarettes compared to nicotine gum and usual brand cigarettes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Tobacco Use

Currently open trials in the same condition.

NCT07162935 — Cigar Legislation and Regulation in Tobacco for the Young (Project CLARITY) · NA · recruiting
NCT07132814 — Abuse Liability for Five Modern Oral Nicotine Products · NA · recruiting
NCT07148232 — Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness · Phase 4 · recruiting
NCT06983678 — Neural Correlates and Behavioral Impact of Withdrawal-induced Hyperalgesia Among People Who Smoke With and Without Chron · NA · recruiting
NCT06922617 — STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking · NA · recruiting

Other 22nd Century Group, Inc. trials

Trials by the same sponsor.

NCT03571724 — A Study to Assess Changes in Cigarette Consumption During a Switch to Very Low Nicotine Cigarettes · NA · completed
NCT03559751 — Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Cigarettes · Phase 1 · completed

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 NCT03559725 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by 22nd Century Group, Inc.
Last refreshed: 25 March 2020

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/NCT03559725.

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