Effect of Galantamine on Smoking Abstinence
NCT01548638 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2017-12-26
Summary
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.
Conditions
- Nicotine Addiction
Interventions
- DRUG
-
Galantamine ER
The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily. Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Rebecca Ashare, Ph.D. · University of Pennsylvania
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-02-29
- Primary Completion
- 2012-08-31
- Completion
- 2013-10-31
Countries
- United States
Study Locations
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