An interventional study of Placebo patch & placebo capsule and Placebo patch & galantamine capsule in Basic Science Study of the Mechanisms of Attentional Enhancement by Compounds Acting on the Nicotinic Receptor, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-04.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Basic science
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.
University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
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Exclusion Criteria:
On the double-placebo test day, participants receive a placebo patch and a placebo capsule.
Drug: Placebo patch & placebo capsule
On the nicotine test day, participants receive a nicotine patch (7 mg/24 hrs) and a placebo capsule.
Drug: Nicotine patch & placebo capsule
On the galantamine test day, participants receive a placebo patch and a capsule containing 4 mg of galantamine.
Drug: Placebo patch & 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.
Drug: Nicotine patch and galantamine capsule
On this test day, cognition is assessed after administration of a placebo patch and a placebo capsule.
On this test day, cognition is assessed after administration of a placebo patch and a galantamine capsule (4 mg p.o.).
On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a placebo 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.).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 15 min
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.
Time frame: 5 min
| Milestone | Healthy Adults |
|---|---|
| Started | 43 |
| Completed | 27 |
| Not completed | 16 |
| Withdrew: Adverse event | 7 |
| Withdrew: Pregnancy | 1 |
| Withdrew: Withdrawal by subject | 6 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Protocol violation | 1 |
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.
| ms | Placebo Patch and Placebo Capsule | Nicotine Patch and Placebo Capsule | Placebo Patch and Galantamine Capsule | Nicotine Patch and Galantamine Capsule |
|---|---|---|---|---|
| Spatial Attentional Resource Allocation Task Predictive Trials Reaction Time | 420 ± 66 | 408 ± 56 | 416 ± 61 | 413 ± 63 |
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.
| percentage of all targets | Placebo Patch and Placebo Capsule | Nicotine Patch and Placebo Capsule | Placebo Patch and Galantamine Capsule | Nicotine Patch and Galantamine Capsule |
|---|---|---|---|---|
| Rapid Visual Information Processing Task Hit Rate | 50 ± 19 | 54 ± 18 | 49 ± 21 | 54 ± 19 |
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.
| percentage of all trials | Placebo Patch and Placebo Capsule | Nicotine Patch and Placebo Capsule | Placebo Patch and Galantamine Capsule | Nicotine Patch and Galantamine Capsule |
|---|---|---|---|---|
| Change Detection Task Accuracy | 83 ± 6 | 83 ± 6 | 84 ± 6 | 84 ± 6 |
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.
| ms | Placebo Patch and Placebo Capsule | Nicotine Patch and Placebo Capsule | Placebo Patch and Galantamine Capsule | Nicotine Patch and Galantamine Capsule |
|---|---|---|---|---|
| Spatial Attentional Resource Allocation Task (SARAT) Non-predictive Trial Reaction Time | 472 ± 71 | 455 ± 62 | 465 ± 66 | 449 ± 64 |
The task requires the detection of three consecutive odd or three consecutive even digits in a stream of sequentially presented digits.
| ms | Placebo Patch and Placebo Capsule | Nicotine Patch and Placebo Capsule | Placebo Patch and Galantamine Capsule | Nicotine Patch and Galantamine Capsule |
|---|---|---|---|---|
| Rapid Visual Information Processing Task Reaction Time | 463 ± 59 | 459 ± 64 | 473 ± 70 | 459 ± 63 |
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.
| ms | Placebo Patch and Placebo Capsule | Nicotine Patch and Placebo Capsule | Placebo Patch and Galantamine Capsule | Nicotine Patch and Galantamine Capsule |
|---|---|---|---|---|
| Change Detection Task Reaction Time | 1018 ± 241 | 1023 ± 216 | 1043 ± 239 | 973 ± 225 |
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.
| score on a scale | Placebo Patch and Placebo Capsule | Nicotine Patch and Placebo Capsule | Placebo Patch and Galantamine Capsule | Nicotine Patch and Galantamine Capsule |
|---|---|---|---|---|
| Profile of Mood Scale - Total Mood Disturbance | -0.32 ± 0.91 | -0.48 ± 0.98 | -0.60 ± 0.99 | -0.43 ± 1.16 |
Collected over During each of the four test sessions (7 hours each).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Patch and Placebo Capsule | 0/32 (0%) | 0/32 (0%) | 1/32 (3.1%) |
| Nicotine Patch and Placebo Capsule | 0/34 (0%) | 0/34 (0%) | 5/34 (14.7%) |
| Placebo Patch and Galantamine Capsule | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Nicotine Patch and Galantamine Capsule | 0/32 (0%) | 0/32 (0%) | 4/32 (12.5%) |
| Event | Placebo Patch and Placebo Capsule | Nicotine Patch and Placebo Capsule | Placebo Patch and Galantamine Capsule | Nicotine Patch and Galantamine Capsule |
|---|---|---|---|---|
| nauseaGastrointestinal disorders | 0/32 | 5/34 | 0/30 | 4/32 |
| vomitingGastrointestinal disorders | 0/32 | 4/34 | 0/30 | 4/32 |
| pain at patch siteSkin and subcutaneous tissue disorders | 1/32 | 0/34 | 0/30 | 0/32 |
| palpitationsCardiac disorders | 0/32 | 1/34 | 0/30 | 0/32 |
This includes 27 study completers and 16 study non-completers.
| Age, Continuous(years) | Healthy Adults |
|---|---|
| Mean | 33.3 ± 10.5 |
| Sex: Female, Male(Participants) | Healthy Adults |
|---|---|
| Female | 27 |
| Male | 16 |
| Ethnicity (NIH/OMB)(Participants) | Healthy Adults |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 38 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Healthy Adults |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 18 |
| White | 18 |
| More than one race | 3 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Healthy Adults |
|---|---|
| United States | 43 |
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University of Maryland, Baltimore