NCT01548638

The Effect of the Acetylcholinesterase Inhibitor, Galantamine, on Short-term Abstinence

Completed Phase 2 Results posted Last updated 27 November 2017

What this trial tests

Phase 2 trial testing Galantamine ER in Nicotine Addiction in 13 participants. Completed in 1 October 2013.

Timeline

1 February 2012

Primary endpoint
1 August 2012

1 October 2013

Quick facts

Lead sponsor	University of Pennsylvania
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	1 February 2012
Primary completion	1 August 2012
Estimated completion	1 October 2013
Sites	1 location across United States

Drugs / interventions tested

• Galantamine ER

Conditions studied

• Nicotine Addiction — all drugs for Nicotine Addiction →

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 60, any sex, with Nicotine Addiction. 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.

• Number of Days of Abstinence During a 7-day Quit Attempt
  Time frame: Days 36-43; following a 5-week dose run-up
  Participants will undergo a 6-week study medication period. Day 36 will be the beginning of a 7-day practice quit attempt, during which number of days of abstinence will be assessed.

Sponsor's own description

This is a preliminary open-label study to determine 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

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

1. The case of galantamine: repurposing and late blooming of a cholinergic drug.
   Mucke HA. · · 2015 · cited 31× · PMID 28031923 · DOI 10.4155/fso.15.73