Who is sponsoring NCT03164668?

NCT03164668 is sponsored by University of Minnesota.

What drugs are being tested in NCT03164668?

Interventions in NCT03164668: menthol flavored e-cigarette, tobacco flavored e-cigarette.

What condition does NCT03164668 study?

NCT03164668 studies Tobacco Use Disorder.

Is NCT03164668 still recruiting?

NCT03164668 is currently completed. Last updated 10 July 2024.

Are results published for NCT03164668?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-07-10 · How we verify

NCT03164668

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

Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes

Completed NA Results posted Last updated 10 July 2024

What this trial tests

NA trial testing menthol flavored e-cigarette in Tobacco Use Disorder in 37 participants. Completed in 26 November 2019.

Timeline

3 May 2017

Primary endpoint
1 November 2019

26 November 2019

Quick facts

Lead sponsor	University of Minnesota
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	37
Start date	3 May 2017
Primary completion	1 November 2019
Estimated completion	26 November 2019
Sites	1 location across United States

Drugs / interventions tested

menthol flavored e-cigarette
tobacco flavored e-cigarette

Conditions studied

Tobacco Use Disorder — all drugs for Tobacco Use Disorder →

Sponsor

University of Minnesota

Who can join

Adults 18 to 64, any sex, with Tobacco Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Cigarettes Smoked Per Day Primary · 1 month

Number of cigarettes smoked per day as self-reported on tobacco diary

Group	Value	95% CI
Avoid Menthol Cigarettes; Menthol E-cigarettes	2.2
Avoid Menthol Cigarettes; Tobacco E-cigarettes	1.8
Can Continue Smoking Usual Cigarettes; Menthol E-cigarettes	6.0
Can Continue Smoking Usual Cigarettes; Tobacco E-cigarettes	7.1

Number of E-cigarette Puffs Used Per Day Primary · 1 month

Self-reported number of puffs of e-cigarettes used per day

Group	Value	95% CI
Avoid Menthol Cigarettes; Menthol E-cigarettes	61.4
Avoid Menthol Cigarettes; Tobacco E-cigarettes	57
Can Continue Smoking Usual Cigarettes; Menthol E-cigarettes	25.5
Can Continue Smoking Usual Cigarettes; Tobacco E-cigarettes	14.9

Adverse events — posted to ClinicalTrials.gov

Time frame: For the duration of each participant's participation in the specified condition (up to approximately 4 weeks for each participant). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Avoid Menthol Cigarettes; Receive Menthol E-cigarettes

Serious: 0/16 (0%)

Deaths: 0/16

Avoid Menthol Cigarettes; Receive Tobacco E-cigarettes

Serious: 0/18 (0%)

Deaths: 0/18

Usual Cigarettes; Receive Menthol E-cigarettes

Serious: 0/16 (0%)

Deaths: 0/16

Usual Cigarettes; Receive Tobacco E-cigarettes

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (3 terms — click to expand)

Reaction	System	Avoid Menthol Cigarettes; …	Avoid Menthol Cigarettes; …	Usual Cigarettes; Receive …	Usual Cigarettes; Receive …
Headache	General disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Lightheaded	General disorders	—	—	—	—

Data from ClinicalTrials.gov NCT03164668 adverse events section.

Sponsor's own description

The purpose of this formative study is to provide preliminary data regarding how the availability of menthol flavored e-cigarettes affects tobacco use behavior in the context of a ban on menthol flavored 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 Disorder

Currently open trials in the same condition.

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NCT06883162 — Cannabis-Tobacco Co-Use Treatment Study · Phase 3 · recruiting
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Other University of Minnesota trials

Trials by the same sponsor.

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NCT03192007 — Multi-Parametric MRI for Renal Transplantation · not yet recruiting
NCT04940533 — Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers · not yet recruiting

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 NCT03164668 (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 University of Minnesota
Last refreshed: 10 July 2024

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/NCT03164668.

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