Effect of Galantamine on Short-term Abstinence (GAL-K)
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|ClinicalTrials.gov Identifier: NCT01669538|
Recruitment Status : Completed
First Posted : August 21, 2012
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Disorder||Drug: Galantamine Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Repurposing Cholinesterase Inhibitors for Smoking Cessation.|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
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
- 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.
- 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) ]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 ]
Smoking urges [Questionnaire of Smoking Urges-Brief; QSU-B; 10-items rated on a 7-point scale (1=strongly disagree, 7=strongly agree) and summed for total score (range: 10-70). Higher scores=greater urge to smoke.] Negative mood [Negative Affect scale (10 items) from the Positive and Negative Affect Schedule; PANAS; 20-item Likert-format measure; The subscale was summed to create a summary score (range: 10-50); Lower negative affect indicates better outcomes.] Nicotine withdrawal [Minnesota Nicotine Withdrawal Scale-Revised; MNWS-R; 15 symptoms are rated on intensity with the following scale: 0=none, 1=slight, 2=mild, 3=moderate, 4=severe. The first 9 items are summed for total score (range: 0-36); higher scores=more severe withdrawal.].
Measures assessed at the following visits: Baseline; Day 7 (monitoring visit); Day 14 (Day before 24-hour abstinence period), Day 16 (after 24-hour abstinence period), and Days 17-23 (7-day quit attempt).
- Common Side Effects of Galantamine Check List [ Time Frame: Baseline (day 0), Days 7, 14, 16, 17, 19, 21, and 23 ]
Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects rated the severity of 37 common side effects of galantamine on the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The average of all items was used to create a summary side effect score (range for total summary score 0-3). Higher scores indicate greater severity of side effects.
Side effects of galantamine were 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669538
|United States, Pennsylvania|
|Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Rebecca Ashare, Ph.D.||University of Pennsylvania|