N/A
Completed N=43
Low-Dose Galantamine to Potentiate the Attention-Enhancing Effects of Low-Dose Nicotine
Basic Science Study of the Mechanisms of Attentional Enhancement by Compounds Acting on the Nicotinic Receptor
Source: ClinicalTrials.gov NCT02420327 ↗
Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Spatial Attentional Resource Allocation Task Predictive Trials Reaction Time — 420; 408; 416; 413 ms
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Spatial Attentional Resource Allocation Task Predictive Trials Reaction Time |
420; 408; 416; 413 | — |
| PRIMARY Rapid Visual Information Processing Task Hit Rate |
50; 54; 49; 54 | — |
| PRIMARY Change Detection Task Accuracy |
83; 83; 84; 84 | — |
| PRIMARY Spatial Attentional Resource Allocation Task (SARAT) Non-predictive Trial Reaction Time |
472; 455; 465; 449 | — |
| PRIMARY Rapid Visual Information Processing Task Reaction Time |
463; 459; 473; 459 | — |
| PRIMARY Change Detection Task Reaction Time |
1018; 1023; 1043; 973 | — |
| SECONDARY Profile of Mood Scale - Total Mood Disturbance |
-0.32; -0.48; -0.60; -0.43 | — |
Eligibility Criteria
Inclusion Criteria
- Aged 21 to 55 years.
- No exposure to any nicotine-containing product in the last year.
- Smoked no more that 40 cigarettes, cigars or cigarillos in lifetime.
- Normal or corrected to normal vision (at least 20/80).
- Body weight 110-220 lbs.
Exclusion Criteria
- Pregnant or breast-feeding.
- Drug or alcohol abuse or dependence currently or in the last 2 years.
- DSM Axis I mood, anxiety or psychotic disorder.
- Cardiovascular or cerebrovascular disease, such as history of myocardial infarction and ischemia, heart failure, angina, stroke, severe arrhythmias, or EKG abnormalities (Wolf-Parkinson-White syndrome, Complete left bundle branch block, PR interval 200 ms, Prolonged QT interval (corrected) >500 ms, Cardiac arrhythmias as defined by PACs >3 per min or PVCs >1 per min).
- Uncontrolled hypertension (resting systolic BP above 140 or diastolic above 90 mm Hg).
- Hypotension (resting systolic BP below 90 or diastolic below 60).
- Significant kidney or liver impairment.
- Moderate to severe asthma.
- Obstructive pulmonary disease.
- Type I or II diabetes.
- Use of any centrally active medications; any peripherally acting cholinergic medications; cimetidine; ketoconazole; erythromycin; quinidine, or chronic nonsteroidal anti-inflammatory drugs.
- History of or current neurological illnesses, such as stroke, seizure disorders, neurodegenerative diseases, or organic brain syndrome.
- Learning disability, mental retardation, or any other condition that impedes cognition.
- Heart rate <55 bpm.
- Current or history of gastric ulcer disease.
- Any surgeries requiring full anesthesia scheduled within 2 weeks of any of the study test sessions.
- Anemia.
- Inability to perform the Rapid Visual Information Processing Task.
Data sourced from ClinicalTrials.gov (NCT02420327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.