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The aim of this study is to test whether the attention-enhancing effects of low-dose nicotine can be enhanced by the drug galantamine, FDA-approved for the treatment of Alzheimer's disease. This proof-of-principle study is performed in healthy non-smokers and involves two single exposures to a nicotine patch (7 mg/24 hrs) and two single exposures to galantamine (4 mg). The dose of galantamine is substantially lower than the clinical dose range of 16-24 mg/day. The hypothesis is that performance-enhancing effects of nicotine are greater in the presence of this low dose of galantamine.
Healthy non-smokers will be screened for study eligibility and receive training on three different attention tasks. Over four test session, participants will then perform these tasks after receiving (1) a placebo patch and a placebo capsule, (2) a nicotine patch (7 mg/24 hrs) and a placebo capsule, (3) a placebo patch and a galantamine capsule, and (4) a nicotine patch and a galantamine capsule. The four test session are performed on separate days and take approximately 7 hours each. During the first 5 hours, the participant may read or watch TV while nicotine and/or galantamine are being absorbed. During the last two hours, the participant will perform the attention tasks on a computer. The investigators hypothesize that performance-enhancing effects of nicotine, which were documented in previous research, will be larger in the presence than in the absence of galantamine. This proof-of-concept would have implications for the development of drugs for the treatment of conditions such as Alzheimer's disease or schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo patch and placebo capsule | Experimental | On the double-placebo test day, participants receive a placebo patch and a placebo capsule. |
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| Nicotine patch and placebo capsule | Experimental | On the nicotine test day, participants receive a nicotine patch (7 mg/24 hrs) and a placebo capsule. |
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| Placebo patch and galantamine capsule | Experimental | On the galantamine test day, participants receive a placebo patch and a capsule containing 4 mg of galantamine. |
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| Nicotine patch and galantamine capsule | Experimental | On the nicotine + galantamine test day, participants receive a nicotine patch (7 mg/24 hrs) and a capsule containing 4 mg of galantamine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo patch & placebo capsule | Drug | On this test day, cognition is assessed after administration of a placebo patch and a placebo capsule. |
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| Measure | Description | Time Frame |
|---|---|---|
| Spatial Attentional Resource Allocation Task Predictive Trials Reaction Time | The task requires detecting brief target stimuli presented at one of four locations in the four corner of the screen. On predictive trials, a central cue predicts the target location. | 45 min |
| Rapid Visual Information Processing Task Hit Rate | The task requires following a stream of digits and detecting three consecutive odd or even numbers. The Hit Rate reflects the percentage of all target sequences that were detected. | 30 min |
| Change Detection Task Accuracy | The task requires encoding the color of 1 or 5 shape items and reporting whether or not one of the items changed color. Accuracy refers to the percentage of all trials in which a correct response was given. One participant's data were excluded from this task because of excessive no-response trials. | 15 min |
| Spatial Attentional Resource Allocation Task (SARAT) Non-predictive Trial Reaction Time | The task requires responding to brief target stimuli presented randomly in one of four locations in the four corners of the screen. On non-predictive trial, the cue does not provide any advance information about where the target will occur. | 45 min |
| Rapid Visual Information Processing Task Reaction Time | The task requires the detection of three consecutive odd or three consecutive even digits in a stream of sequentially presented digits. | 30 min |
| Change Detection Task Reaction Time | The task requires encoding the color of 1 or 5 shape items and reporting whether or not one of the items changed color. One participant's data were excluded from this task because of excessive no-response trials. |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of Mood Scale - Total Mood Disturbance | Participants rate their current subjective state on a list of adjectives, which contribute to six factors/subscales. "Total Mood Disturbance" is a composite measure, obtained by summing the scores of all subscales, each with a range of 0-4, weighting the one positively valenced factor negatively. Thus, smaller or more negative values represent a more positive mood state. The theoretical range of the "Total Mood Disturbance" measure is from -4 to +20. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Britta Hahn, Ph.D. | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland School of Medicine, Maryland Psychiatric Research Center | Catonsville | Maryland | 21228 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Adults | All participants receive the following four interventions, on separate days, in a counterbalanced order:
Placebo patch & placebo capsule: On this test day, cognition is assessed after administration of a placebo patch and a placebo capsule. Placebo patch & galantamine capsule: On this test day, cognition is assessed after administration of a placebo patch and a galantamine capsule (4 mg p.o.). Nicotine patch & placebo capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a placebo capsule. Nicotine patch and galantamine capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a galantamine capsule (4 mg p.o.). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 3, 2018 |
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| Placebo patch & galantamine capsule | Drug | On this test day, cognition is assessed after administration of a placebo patch and a galantamine capsule (4 mg p.o.). |
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| Nicotine patch & placebo capsule | Drug | On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a placebo capsule. |
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| Nicotine patch and galantamine capsule | Drug | On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a galantamine capsule (4 mg p.o.). |
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| 15 min |
| 5 min |
| COMPLETED |
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| NOT COMPLETED |
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This includes 27 study completers and 16 study non-completers.
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Adults | All participants receive the following four interventions, on separate days, in a counterbalanced order:
Placebo patch & placebo capsule: On this test day, cognition is assessed after administration of a placebo patch and a placebo capsule. Placebo patch & galantamine capsule: On this test day, cognition is assessed after administration of a placebo patch and a galantamine capsule (4 mg p.o.). Nicotine patch & placebo capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a placebo capsule. Nicotine patch and galantamine capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a galantamine capsule (4 mg p.o.). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Spatial Attentional Resource Allocation Task Predictive Trials Reaction Time | The task requires detecting brief target stimuli presented at one of four locations in the four corner of the screen. On predictive trials, a central cue predicts the target location. | 27 healthy adult non-smokers | Posted | Mean | Standard Deviation | ms | 45 min |
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| ||||||||||||||||||||||||||||||||||
| Primary | Rapid Visual Information Processing Task Hit Rate | The task requires following a stream of digits and detecting three consecutive odd or even numbers. The Hit Rate reflects the percentage of all target sequences that were detected. | Healthy adult non-smokers | Posted | Mean | Standard Deviation | percentage of all targets | 30 min |
| ||||||||||||||||||||||||||||||||||||
| Primary | Change Detection Task Accuracy | The task requires encoding the color of 1 or 5 shape items and reporting whether or not one of the items changed color. Accuracy refers to the percentage of all trials in which a correct response was given. One participant's data were excluded from this task because of excessive no-response trials. | Healthy adult non-smokers | Posted | Mean | Standard Deviation | percentage of all trials | 15 min |
| ||||||||||||||||||||||||||||||||||||
| Primary | Spatial Attentional Resource Allocation Task (SARAT) Non-predictive Trial Reaction Time | The task requires responding to brief target stimuli presented randomly in one of four locations in the four corners of the screen. On non-predictive trial, the cue does not provide any advance information about where the target will occur. | Healthy adult non-smokers | Posted | Mean | Standard Deviation | ms | 45 min |
| ||||||||||||||||||||||||||||||||||||
| Primary | Rapid Visual Information Processing Task Reaction Time | The task requires the detection of three consecutive odd or three consecutive even digits in a stream of sequentially presented digits. | Healthy adult non-smokers | Posted | Mean | Standard Deviation | ms | 30 min |
| ||||||||||||||||||||||||||||||||||||
| Primary | Change Detection Task Reaction Time | The task requires encoding the color of 1 or 5 shape items and reporting whether or not one of the items changed color. One participant's data were excluded from this task because of excessive no-response trials. | Healthy adult non-smokers | Posted | Mean | Standard Deviation | ms | 15 min |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Profile of Mood Scale - Total Mood Disturbance | Participants rate their current subjective state on a list of adjectives, which contribute to six factors/subscales. "Total Mood Disturbance" is a composite measure, obtained by summing the scores of all subscales, each with a range of 0-4, weighting the one positively valenced factor negatively. Thus, smaller or more negative values represent a more positive mood state. The theoretical range of the "Total Mood Disturbance" measure is from -4 to +20. | Healthy adult non-smokers | Posted | Mean | Standard Deviation | score on a scale | 5 min |
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During each of the four test sessions (7 hours each).
Participants had vital signs taken and completed a side-effects checklist hourly (after patch) or every thirty minutes (after capsule). Unsolicited reports of adverse effects were also recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Patch and Placebo Capsule | On the double-placebo test day, participants receive a placebo patch and a placebo capsule. Placebo patch & placebo capsule: On this test day, cognition is assessed after administration of a placebo patch and a placebo capsule. | 0 | 32 | 0 | 32 | 1 | 32 |
| EG001 | Nicotine Patch and Placebo Capsule | On the nicotine test day, participants receive a nicotine patch (7 mg/24 hrs) and a placebo capsule. Nicotine patch & placebo capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a placebo capsule. | 0 | 34 | 0 | 34 | 5 | 34 |
| EG002 | Placebo Patch and Galantamine Capsule | On the galantamine test day, participants receive a placebo patch and a capsule containing 4 mg of galantamine. Placebo patch & galantamine capsule: On this test day, cognition is assessed after administration of a placebo patch and a galantamine capsule (4 mg p.o.). | 0 | 30 | 0 | 30 | 0 | 30 |
| EG003 | Nicotine Patch and Galantamine Capsule | On the nicotine + galantamine test day, participants receive a nicotine patch (7 mg/24 hrs) and a capsule containing 4 mg of galantamine. Nicotine patch and galantamine capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a galantamine capsule (4 mg p.o.). | 0 | 32 | 0 | 32 | 4 | 32 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| nausea | Gastrointestinal disorders | Systematic Assessment |
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| palpitations | Cardiac disorders | Systematic Assessment |
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| pain at patch site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Britta Hahn | University of Maryland School of Medicine | 410-402-6112 | bhahn@som.umaryland.edu |
| Jul 3, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005702 | Galantamine |
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D047151 | Amaryllidaceae Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013812 | Therapeutics |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG003 | Nicotine Patch and Galantamine Capsule | On the nicotine + galantamine test day, participants receive a nicotine patch (7 mg/24 hrs) and a capsule containing 4 mg of galantamine. Nicotine patch and galantamine capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a galantamine capsule (4 mg p.o.). |
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| OG003 | Nicotine Patch and Galantamine Capsule | On the nicotine + galantamine test day, participants receive a nicotine patch (7 mg/24 hrs) and a capsule containing 4 mg of galantamine. Nicotine patch and galantamine capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a galantamine capsule (4 mg p.o.). |
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| OG003 | Nicotine Patch and Galantamine Capsule | On the nicotine + galantamine test day, participants receive a nicotine patch (7 mg/24 hrs) and a capsule containing 4 mg of galantamine. Nicotine patch and galantamine capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a galantamine capsule (4 mg p.o.). |
|
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| OG003 | Nicotine Patch and Galantamine Capsule | On the nicotine + galantamine test day, participants receive a nicotine patch (7 mg/24 hrs) and a capsule containing 4 mg of galantamine. Nicotine patch and galantamine capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a galantamine capsule (4 mg p.o.). |
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| OG003 | Nicotine Patch and Galantamine Capsule | On the nicotine + galantamine test day, participants receive a nicotine patch (7 mg/24 hrs) and a capsule containing 4 mg of galantamine. Nicotine patch and galantamine capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a galantamine capsule (4 mg p.o.). |
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On the galantamine test day, participants receive a placebo patch and a capsule containing 4 mg of galantamine.
Placebo patch & galantamine capsule: On this test day, cognition is assessed after administration of a placebo patch and a galantamine capsule (4 mg p.o.).
| OG003 | Nicotine Patch and Galantamine Capsule | On the nicotine + galantamine test day, participants receive a nicotine patch (7 mg/24 hrs) and a capsule containing 4 mg of galantamine. Nicotine patch and galantamine capsule: On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a galantamine capsule (4 mg p.o.). |
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