Trial Outcomes & Findings for Low-Dose Galantamine to Potentiate the Attention-Enhancing Effects of Low-Dose Nicotine (NCT NCT02420327)
NCT ID: NCT02420327
Last Updated: 2019-11-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
45 min
Results posted on
2019-11-04
Participant Flow
Participant milestones
| Measure |
Healthy Adults
All participants receive the following four interventions, on separate days, in a counterbalanced order:
1. placebo patch and placebo capsule
2. placebo patch and galantamine capsule
3. nicotine patch and placebo capsule
4. nicotine patch and galantamine capsule
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.).
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Healthy Adults
All participants receive the following four interventions, on separate days, in a counterbalanced order:
1. placebo patch and placebo capsule
2. placebo patch and galantamine capsule
3. nicotine patch and placebo capsule
4. nicotine patch and galantamine capsule
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.).
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Low-Dose Galantamine to Potentiate the Attention-Enhancing Effects of Low-Dose Nicotine
Baseline characteristics by cohort
| Measure |
Healthy Adults
n=43 Participants
All participants receive the following four interventions, on separate days, in a counterbalanced order:
1. placebo patch and placebo capsule
2. placebo patch and galantamine capsule
3. nicotine patch and placebo capsule
4. nicotine patch and galantamine capsule
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.).
|
|---|---|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 45 minPopulation: 27 healthy adult non-smokers
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.
Outcome measures
| Measure |
Placebo Patch and Placebo Capsule
n=27 Participants
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.
|
Nicotine Patch and Placebo Capsule
n=27 Participants
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.
|
Placebo Patch and Galantamine Capsule
n=27 Participants
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.).
|
Nicotine Patch and Galantamine Capsule
n=27 Participants
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.).
|
|---|---|---|---|---|
|
Spatial Attentional Resource Allocation Task Predictive Trials Reaction Time
|
420 ms
Standard Deviation 66
|
408 ms
Standard Deviation 56
|
416 ms
Standard Deviation 61
|
413 ms
Standard Deviation 63
|
PRIMARY outcome
Timeframe: 30 minPopulation: Healthy adult non-smokers
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.
Outcome measures
| Measure |
Placebo Patch and Placebo Capsule
n=27 Participants
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.
|
Nicotine Patch and Placebo Capsule
n=27 Participants
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.
|
Placebo Patch and Galantamine Capsule
n=27 Participants
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.).
|
Nicotine Patch and Galantamine Capsule
n=27 Participants
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.).
|
|---|---|---|---|---|
|
Rapid Visual Information Processing Task Hit Rate
|
50 percentage of all targets
Standard Deviation 19
|
54 percentage of all targets
Standard Deviation 18
|
49 percentage of all targets
Standard Deviation 21
|
54 percentage of all targets
Standard Deviation 19
|
PRIMARY outcome
Timeframe: 15 minPopulation: Healthy adult non-smokers
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.
Outcome measures
| Measure |
Placebo Patch and Placebo Capsule
n=26 Participants
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.
|
Nicotine Patch and Placebo Capsule
n=26 Participants
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.
|
Placebo Patch and Galantamine Capsule
n=26 Participants
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.).
|
Nicotine Patch and Galantamine Capsule
n=26 Participants
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.).
|
|---|---|---|---|---|
|
Change Detection Task Accuracy
|
83 percentage of all trials
Standard Deviation 6
|
83 percentage of all trials
Standard Deviation 6
|
84 percentage of all trials
Standard Deviation 6
|
84 percentage of all trials
Standard Deviation 6
|
PRIMARY outcome
Timeframe: 45 minPopulation: Healthy adult non-smokers
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.
Outcome measures
| Measure |
Placebo Patch and Placebo Capsule
n=27 Participants
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.
|
Nicotine Patch and Placebo Capsule
n=27 Participants
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.
|
Placebo Patch and Galantamine Capsule
n=27 Participants
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.).
|
Nicotine Patch and Galantamine Capsule
n=27 Participants
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.).
|
|---|---|---|---|---|
|
Spatial Attentional Resource Allocation Task (SARAT) Non-predictive Trial Reaction Time
|
472 ms
Standard Deviation 71
|
455 ms
Standard Deviation 62
|
465 ms
Standard Deviation 66
|
449 ms
Standard Deviation 64
|
PRIMARY outcome
Timeframe: 30 minPopulation: Healthy adult non-smokers
The task requires the detection of three consecutive odd or three consecutive even digits in a stream of sequentially presented digits.
Outcome measures
| Measure |
Placebo Patch and Placebo Capsule
n=27 Participants
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.
|
Nicotine Patch and Placebo Capsule
n=27 Participants
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.
|
Placebo Patch and Galantamine Capsule
n=27 Participants
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.).
|
Nicotine Patch and Galantamine Capsule
n=27 Participants
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.).
|
|---|---|---|---|---|
|
Rapid Visual Information Processing Task Reaction Time
|
463 ms
Standard Deviation 59
|
459 ms
Standard Deviation 64
|
473 ms
Standard Deviation 70
|
459 ms
Standard Deviation 63
|
PRIMARY outcome
Timeframe: 15 minPopulation: Healthy adult non-smokers
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.
Outcome measures
| Measure |
Placebo Patch and Placebo Capsule
n=26 Participants
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.
|
Nicotine Patch and Placebo Capsule
n=26 Participants
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.
|
Placebo Patch and Galantamine Capsule
n=26 Participants
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.).
|
Nicotine Patch and Galantamine Capsule
n=26 Participants
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.).
|
|---|---|---|---|---|
|
Change Detection Task Reaction Time
|
1018 ms
Standard Deviation 241
|
1023 ms
Standard Deviation 216
|
1043 ms
Standard Deviation 239
|
973 ms
Standard Deviation 225
|
SECONDARY outcome
Timeframe: 5 minPopulation: Healthy adult non-smokers
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.
Outcome measures
| Measure |
Placebo Patch and Placebo Capsule
n=27 Participants
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.
|
Nicotine Patch and Placebo Capsule
n=27 Participants
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.
|
Placebo Patch and Galantamine Capsule
n=27 Participants
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.).
|
Nicotine Patch and Galantamine Capsule
n=27 Participants
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.).
|
|---|---|---|---|---|
|
Profile of Mood Scale - Total Mood Disturbance
|
-0.32 score on a scale
Standard Deviation 0.91
|
-0.48 score on a scale
Standard Deviation 0.98
|
-0.60 score on a scale
Standard Deviation 0.99
|
-0.43 score on a scale
Standard Deviation 1.16
|
Adverse Events
Placebo Patch and Placebo Capsule
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Nicotine Patch and Placebo Capsule
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo Patch and Galantamine Capsule
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nicotine Patch and Galantamine Capsule
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Patch and Placebo Capsule
n=32 participants at risk
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.
|
Nicotine Patch and Placebo Capsule
n=34 participants at risk
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.
|
Placebo Patch and Galantamine Capsule
n=30 participants at risk
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.).
|
Nicotine Patch and Galantamine Capsule
n=32 participants at risk
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.).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/32 • 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.
|
11.8%
4/34 • Number of events 4 • 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.
|
0.00%
0/30 • 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.
|
12.5%
4/32 • Number of events 4 • 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.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/32 • 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.
|
14.7%
5/34 • Number of events 5 • 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.
|
0.00%
0/30 • 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.
|
12.5%
4/32 • Number of events 4 • 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.
|
|
Cardiac disorders
palpitations
|
0.00%
0/32 • 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.
|
2.9%
1/34 • Number of events 1 • 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.
|
0.00%
0/30 • 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.
|
0.00%
0/32 • 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.
|
|
Skin and subcutaneous tissue disorders
pain at patch site
|
3.1%
1/32 • Number of events 1 • 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.
|
0.00%
0/34 • 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.
|
0.00%
0/30 • 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.
|
0.00%
0/32 • 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.
|
Additional Information
Dr. Britta Hahn
University of Maryland School of Medicine
Phone: 410-402-6112
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place