NCT01669538 (GAL-K) is a Phase 2 clinical trial of Galantamine in Tobacco Use Disorder, sponsored by University of Pennsylvania.

Who is sponsoring NCT01669538?

NCT01669538 is sponsored by University of Pennsylvania.

What drugs are being tested in NCT01669538?

Interventions in NCT01669538: Galantamine, Placebo.

What condition does NCT01669538 study?

NCT01669538 studies Tobacco Use Disorder.

Is NCT01669538 still recruiting?

NCT01669538 is currently completed. Last updated 22 January 2019.

Are results published for NCT01669538?

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

Last reviewed 2019-01-22 · How we verify

NCT01669538: GAL-K

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

Repurposing Cholinesterase Inhibitors for Smoking Cessation.

Completed Phase 2 Results posted Last updated 22 January 2019

What this trial tests

Phase 2 trial testing Galantamine in Tobacco Use Disorder in 98 participants. Completed in 1 November 2017.

Timeline

1 August 2012

Primary endpoint
1 November 2017

1 November 2017

Quick facts

Lead sponsor	University of Pennsylvania
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	98
Start date	1 August 2012
Primary completion	1 November 2017
Estimated completion	1 November 2017
Sites	1 location across United States

Drugs / interventions tested

Galantamine (GALANTAMINE) — full drug profile →
Placebo

Conditions studied

Tobacco Use Disorder — all drugs for Tobacco Use Disorder →

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 60, any sex, with Tobacco Use Disorder. 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.

Total Number of Smoke-free Days (Biochemically Verified) During a 7-day Quit Attempt.
Time frame: Days 17-23
Day 17 will be the beginning of a 7-day quit attempt, during which the total number of days of abstinence will be assessed.

Sponsor's own description

This is a randomized, double-blind, placebo-controlled study to test whether a medication called galantamine (Brand Name: Razadyne) will help smokers quit and whether it reduces cognitive problems that smokers experience during a quit attempt.

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 Galantamine

Trials testing the same drug.

NCT07003386 — Exploration of the Efficacy and Mechanism of Galantamine (an Extract From Lycoris Aurea) in Treating Ischemic Stroke · Phase 2, PHASE3 · recruiting
NCT04769206 — Enhancing Parasympathetic Activity to Improve Endothelial Dysfunction, Vascular Oxidative Stress in African Americans · Phase 1, PHASE2 · active not recruiting
NCT03384784 — Effect of Galantamine on Inflammation and Cognition · Phase 2 · completed
NCT01677754 — A Study of RO4602522 in Participants With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy · Phase 2 · completed

Other recruiting trials for Tobacco Use Disorder

Currently open trials in the same condition.

NCT07466875 — Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients · NA · recruiting
NCT06678672 — Contingency Management for Veteran Smokers Undergoing Major Elective Surgery · NA · recruiting
NCT06006143 — Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2 · Phase 2 · active not recruiting
NCT06883162 — Cannabis-Tobacco Co-Use Treatment Study · Phase 3 · recruiting
NCT06798324 — tDCS Plus Varenicline for Smoking Cessation · Phase 4 · recruiting

Other University of Pennsylvania trials

Trials by the same sponsor.

NCT06081153 — Mechanistic Clinical Trial of PCSK9 Inhibition for AAA · EARLY_PHASE1 · not yet recruiting
NCT07415772 — Effect of cTBS on Startle and TMS-evoked BOLD · NA · not yet recruiting
NCT07489430 — DaxibotulinumtoxinA for Blepharospasm · Phase 2 · not yet recruiting
NCT07463131 — Negative Income Tax Trial · NA · not yet recruiting
NCT06645769 — Na-Phenylbutyrate VAscular Trial · EARLY_PHASE1 · 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 NCT01669538 (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 Pennsylvania
Last refreshed: 22 January 2019

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/NCT01669538.

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