Effect of Galantamine on Short-term Abstinence (GAL-K)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Repurposing Cholinesterase Inhibitors for Smoking Cessation.|
- Total number of smoke-free days (biochemically verified) during a 7-day quit attempt. [ Time Frame: Days 17-23 ] [ Designated as safety issue: No ]Day 17 will be the beginning of a 7-day quit attempt, during which the total number of days of abstinence will be assessed.
- Cognitive performance [ Time Frame: Baseline (Day 0), Day 14 (day before start of 24-hour abstinence period), Day 16 (after 24-hour abstinence period ends) ] [ Designated as safety issue: No ]Participants will complete neurocognitive tests designed to test working memory and attention. These tests are similar to computer games, in that participants will push a button in response to the pictures they see.
- Subjective symptoms [ Time Frame: Baseline (day 0), Days 7, 14, 16, 17, 19, 21, and 23 ] [ Designated as safety issue: No ]The subjective symptoms, such as smoking behavior, smoking urges, mood, and nicotine withdrawal symptoms, will be assessed at the following in-person sessions: Baseline session; Day 7 (brief monitoring visit); Day 14 (Day before 24-hour abstinence period), Day 16 (after 24-hour abstinence period), and Days 17-23 (during the 7-day quit attempt).
- Side effects of galantamine [ Time Frame: Baseline (day 0), Days 7, 14, 16, 17, 19, 21, and 23 ] [ Designated as safety issue: Yes ]Side effects of galantamine will be assessed at the following in-person sessions: Baseline session; Day 7 (brief monitoring visit); Day 14 (Day before 24-hour abstinence period), Day 16 (after 24-hour abstinence period), and Days 17-23 (during the 7-day quit attempt).
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||February 2018 (Final data collection date for primary outcome measure)|
Galantamine hydrobromide-ER (extended release) is currently marketed for the treatment of Alzheimer's disease. The dosing regimen follows the FDA-approved guidelines. For the first week of study treatment, participants will take 8mg daily of galantamine-ER, preferably with food. 8mg is the lowest dose and this period is designed to introduce the medication into their system. After the initial week, participants will increase their daily dose to 16mg. They will remain on 16mg daily until the end of the treatment period for a total of 23 days on active study medication.
Galantamine will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.
Placebo Comparator: Placebo
Participants assigned to the placebo (sugar pill) arm will take one capsule daily, preferably with food, for a total of 23 days. They will follow the same instructions and complete the same procedures as those in the active treatment.
Placebo ingredients (sucrose filler and gel capsules) will be purchased, encapsulated, and packaged into blister packs by the Investigational Drug Service at the University of Pennsylvania. Both active medication and placebo will look identical.
Other Name: Sugar pill
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 randomized double-blind placebo-controlled study of short-term (23 days) treatment with galantamine.
Eighty chronic smokers will complete a validated procedure for screening new medications. An equal number of subjects will be assigned to one of two groups: galantamine-ER or placebo. Participants in both groups will take one capsule each day and follow the same procedures. This is not a cross-over trial.
For participants in the galantamine group, following an initial 1-week drug run-up phase (8mg daily of galantamine-ER), the medication dose will be increased to 16mg daily of galantamine-ER for the remainder of the study (up to Day 23).
On Day 15, smokers will begin a mandatory 24-hour abstinence period, which will be followed by a programmed smoking lapse on Day 16. Smokers will then be instructed to abstain for the following 7 days (observed abstinence). Following completion of the study, participants will be offered standard smoking cessation treatment.
On Days 0 (Baseline), 14, and 16, subjects will perform the following computer tasks: a working memory task (Visual/Spatial N-Back), sustained attention tasks (Penn Continuous Performance Task [PCPT-nl] and XO Reaction Time Task), a recall memory task (Word Recognition), an interference control task (Stroop test), and a response inhibition task (Stop Signal Task).
The primary outcome is to identify changes in behavioral performance and subjective symptoms following two weeks treatment of galantamine and after 24 hours of abstinence, compared to baseline.
This 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669538
|Contact: Rebecca Ashare, Ph.D.||firstname.lastname@example.org|
|Contact: Paul Sanborn, M.S.||email@example.com|
|United States, Pennsylvania|
|Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Sub-Investigator: Caryn Lerman, Ph.D.|
|Sub-Investigator: Steven Siegel, M.D., Ph.D.|
|Sub-Investigator: Andrew Strasser, Ph.D.|
|Principal Investigator:||Rebecca Ashare, Ph.D.||University of Pennsylvania|