Basic Science Study of the Mechanisms of Attentional Enhancement by Compounds Acting on the Nicotinic ReceptorGalaNicNCT02420327
Low-Dose Galantamine to Potentiate the Attention-Enhancing Effects of Low-Dose Nicotine
A study testing Nicotine patch and galantamine capsule in people with Basic Science Study of the Mechanisms of Attentional Enhancement by Compounds Acting on the Nicotinic Receptor, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Basic Science Study of the Mechanisms of Attentional Enhancement by Compounds Acting on the Nicotinic Receptor
- What is being tested?
- Nicotine patch and galantamine capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 <120 ms or >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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Medicine, Maryland Psychiatric Research Center
Catonsville, Maryland, 21228
About this study
Official title: The Use of Low-Dose Galantamine to Potentiate the Attention-Enhancing Effects of Low-Dose Nicotine
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.
Read the detailed description
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.
- Being tested
- Placebo patch & placebo capsule, Placebo patch & galantamine capsule, Nicotine patch & placebo capsule, Nicotine patch and galantamine capsule
- Keywords
- nicotine, galantamine, attention, cognition, non-smoker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo patch & placebo capsuleDrug
On this test day, cognition is assessed after administration of a placebo patch and a placebo capsule.
Placebo patch & galantamine capsuleDrug
On this test day, cognition is assessed after administration of a placebo patch and a galantamine capsule (4 mg p.o.).
Nicotine patch & placebo capsuleDrug
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 capsuleDrug
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.).
| Study group | Role | What they receive |
|---|---|---|
| Placebo patch and placebo capsule | Experimental | On the double-placebo test day, participants receive a placebo patch and a placebo capsule. Receives: Drug: Placebo patch & placebo capsule |
| Nicotine patch and placebo capsule | Experimental | On the nicotine test day, participants receive a nicotine patch (7 mg/24 hrs) and a placebo capsule. Receives: Drug: Nicotine patch & placebo capsule |
| Placebo patch and galantamine capsule | Experimental | On the galantamine test day, participants receive a placebo patch and a capsule containing 4 mg of galantamine. Receives: Drug: Placebo patch & galantamine capsule |
| 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. Receives: Drug: Nicotine patch and galantamine capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 15 min
Secondary outcomes (1)
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.
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startSep 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Basic Science Study of the Mechanisms of Attentional Enhancement by Compounds Acting on the Nicotinic ReceptorStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Britta Hahn, University of Maryland, Baltimore
- Investigators
- Britta Hahn, Ph.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420327
- Sponsor's protocol ID
- HP-00057097
- Acronym
- GalaNic
- Status last verified
- Oct 2019
- First submitted
- 14 Apr 2015
- Last updated
- 4 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Low-Dose Galantamine to Potentiate the Attention-Enhancing Effects of Low-Dose Nicotine
- ClinicalTrials.gov ID
- NCT02420327
- Acronym / sponsor ID
- GalaNic / HP-00057097
- Keywords
- nicotine, galantamine, attention, cognition, non-smoker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Posted 17 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo patch and placebo capsule | Experimental | Drug: Placebo patch & placebo capsuleOn the double-placebo test day, participants receive a placebo patch and a placebo capsule. |
| Nicotine patch and placebo capsule | Experimental | Drug: Nicotine patch & placebo capsuleOn the nicotine test day, participants receive a nicotine patch (7 mg/24 hrs) and a placebo capsule. |
| Placebo patch and galantamine capsule | Experimental | Drug: Placebo patch & galantamine capsuleOn the galantamine test day, participants receive a placebo patch and a capsule containing 4 mg of galantamine. |
| Nicotine patch and galantamine capsule | Experimental | Drug: Nicotine patch and galantamine capsuleOn the nicotine + galantamine test day, participants receive a nicotine patch (7 mg/24 hrs) and a capsule containing 4 mg of galantamine. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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 <120 ms or >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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo patch & placebo capsuleOn this test day, cognition is assessed after administration of a placebo patch and a placebo capsule. | Drug | Placebo patch and placebo capsule |
| Placebo patch & galantamine capsuleOn this test day, cognition is assessed after administration of a placebo patch and a galantamine capsule (4 mg p.o.). | Drug | Placebo patch and galantamine capsule |
| Nicotine patch & placebo capsuleOn this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a placebo capsule. | Drug | Nicotine patch and placebo capsule |
| Nicotine patch and galantamine capsuleOn this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a galantamine capsule (4 mg p.o.). | Drug | Nicotine patch and galantamine capsule |
Primary outcome
Spatial Attentional Resource Allocation Task Predictive Trials Reaction Time
Time frame: 45 min
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.
Rapid Visual Information Processing Task Hit Rate
Time frame: 30 min
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.
Change Detection Task Accuracy
Time frame: 15 min
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.
Spatial Attentional Resource Allocation Task (SARAT) Non-predictive Trial Reaction Time
Time frame: 45 min
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.
Rapid Visual Information Processing Task Reaction Time
Time frame: 30 min
The task requires the detection of three consecutive odd or three consecutive even digits in a stream of sequentially presented digits.
Change Detection Task Reaction Time
Time frame: 15 min
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.
1 secondary outcome
Profile of Mood Scale - Total Mood Disturbance
Time frame: 5 min
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britta Hahn, Ph.D. principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine patch and galantamine capsule in people with Basic Science Study of the Mechanisms of Attentional Enhancement by Compounds Acting on the Nicotinic Receptor, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial Attentional Resource Allocation Task Predictive Trials Reaction Time (time frame: 45 min). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.