Effect of Galantamine on Smoking Abstinence
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effect of the Acetylcholinesterase Inhibitor, Galantamine, on Short-term Abstinence|
- Number of days of abstinence during a 7-day quit attempt [ Time Frame: Days 36-43; following a 5-week dose run-up ] [ Designated as safety issue: No ]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.
- Cognitive performance [ Time Frame: At Baseline (Day 0), Day 35 (Day before Target Quit Day), and Day 43 ] [ Designated as safety issue: No ]Participants will complete neurocognitive test designed to test working memory and attention and are similar to computer games, in that participants will push a button in response to the pictures they see.
- Subjective symptoms - smoking behavior, urges, mood, nicotine withdrawal [ Time Frame: Days 7, 14, 21, 28, 35, and 43; Baseline session ] [ Designated as safety issue: No ]The subjective symptoms listed above will be assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt).
- Side effects of galantamine [ Time Frame: Days 7, 14, 21, 28, 35, and 43; Baseline session ] [ Designated as safety issue: Yes ]Side effects of galantamine will be assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt).
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||October 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: 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.
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.
Other Name: Razadyne ER
Galantamine, an FDA-approved treatment for Alzheimer's disease, is used to treat cognitive impairment by enhancing acetylcholine through inhibition of the enzyme, acetylcholinesterase. We propose an open-label pilot feasibility study of short-term (6 weeks) treatment with galantamine.
Sixteen chronic smokers will undergo a validated procedure for screening new medications. Following an initial 4-week drug run-up phase (8mg daily of galantamine-ER), medication dose will be increased to 16 mg daily of galantamine-ER during the fifth and sixth weeks of the study. At the beginning of Week 6, smokers will receive brief counseling and make a 7-day quit attempt.
Following completion of the study participants will be offered standard smoking cessation treatment. Subjects will perform a working memory task (Visual/Spatial N-Back), a sustained attention task (Continuous Performance Task; CPT), a recall memory task (Word Recognition), a cognitive flexibility task (Wisconsin Card Sort Test), and a response inhibition task (Stop Signal Task). The primary outcome is the ability to remain abstinent during a 7-day quit attempt. Secondary outcomes include change in cognitive performance, adherence, and side effects.
This pilot study will provide information about the role of the cholinergic system during brief abstinence and whether enhancing acetylcholine reduces abstinence-induced cognitive symptoms that promote smoking relapse. Information obtained in this study may further establish cognitive performance measures as endophenotypes for nicotine dependence.
|United States, Pennsylvania|
|Center for Interdisciplinary Research on Nicotine Addiction, School of Medicine, University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Caryn Lerman, Ph.D.||University of Pennsylvania|