NCT01443858 is a Phase 2 clinical trial of Meclizine in Smoking Cessation, sponsored by Duke University.

Who is sponsoring NCT01443858?

NCT01443858 is sponsored by Duke University.

What drugs are being tested in NCT01443858?

Interventions in NCT01443858: Meclizine, Nicotine Patch, Placebo.

What condition does NCT01443858 study?

NCT01443858 studies Smoking Cessation.

Is NCT01443858 still recruiting?

NCT01443858 is currently completed. Last updated 29 July 2014.

Are results published for NCT01443858?

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

Last reviewed 2014-07-29 · How we verify

NCT01443858

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

Meclizine as a Potential Smoking Cessation Treatment

Completed Phase 2 Results posted Last updated 29 July 2014

What this trial tests

Phase 2 trial testing Meclizine in Smoking Cessation in 146 participants. Completed in 1 July 2013.

Timeline

1 August 2011

Primary endpoint
1 December 2012

1 July 2013

Quick facts

Lead sponsor	Duke University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	146
Start date	1 August 2011
Primary completion	1 December 2012
Estimated completion	1 July 2013
Sites	4 locations across United States

Drugs / interventions tested

Meclizine (meclizine) — full drug profile →
Nicotine Patch (nicotine-patch) — full drug profile →
Placebo

Conditions studied

Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

Duke University

Who can join

Adults 18 to 65, any sex, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 1
Time frame: After 1 week of treatment (relative to baseline)
To evaluate the effects of meclizine alone on ad lib smoking, the percent decrease in expired air carbon monoxide (CO) at the end of week 1 (relative to baseline) will be compared (using ANOVA) between each meclizine group and placebo.
Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 3
Time frame: After 3 weeks of treatment (relative to baseline)
To evaluate the effects of meclizine as an augmentation treatment in conjunction with nicotine patch, the percent decrease in expired air carbon monoxide (CO) at the end of week 3 (relative to baseline) will be compared (using ANOVA) between each meclizine group and placebo.

Sponsor's own description

The purpose of this study is to evaluate whether meclizine, an antihistamine used to prevent or treat motion sickness, can help smokers quit smoking. This study will also investigate the potential relationship between genes you have inherited and success in quitting smoking.

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 trials of Meclizine

Trials testing the same drug.

NCT02112578 — Non Inferiority of Meclin® (Meclizine Chlorhydrate) Versus Dramin® (Dimenhydrinate) in Control of Acute Vertigo Symptoms · Phase 3 · completed

Other recruiting trials for Smoking Cessation

Currently open trials in the same condition.

NCT07420621 — Preliminary Effectiveness of Enhanced Text Message + Incentives · NA · recruiting
NCT07224087 — Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients · Phase 1 · recruiting
NCT07331519 — Integrating Smoking Cessation With Low-dose CT-screening for Lung Cancer · NA · recruiting
NCT07210567 — Mindfulness-based Ecological Momentary Intervention for Smoking Cessation Among Cancer Survivors · NA · recruiting
NCT07129590 — Trauma-Informed Care for Smoking Cessation for Pregnancy · NA · recruiting

Other Duke University trials

Trials by the same sponsor.

NCT07216456 — Vaginal Dilator Therapy After Pelvic Radiation · NA · not yet recruiting
NCT07519317 — Dosing and Deployment Trial: A Home-based Optokinetic Treatment · NA · not yet recruiting
NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
NCT07216963 — The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services Study · NA · not yet recruiting
NCT07459218 — IDEAS for Hope to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania · NA · 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 NCT01443858 (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 Duke University
Last refreshed: 29 July 2014

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/NCT01443858.

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