Magnetic Resonance ImagingNCT01223404

Nicotinic Modulation of the Default Network

A study testing Nicotine and Mecamylamine in people with Magnetic Resonance Imaging and Cognition, run by University of Maryland, Baltimore at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Magnetic Resonance Imaging, Cognition, Nicotine
What is being tested?: Nicotine and Mecamylamine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 2 sitesUnited States
Study dates: Oct 2010to Sep 2013
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age 21 through 50.
Did not consume cigarettes, cigarillos, cigars, or other tobacco or nicotine-containing products more than 20 times in lifetime, and did not use any nicotine-containing product at all within the last two years.
Normal or corrected to normal vision (at least 20/80).

Who cannot join

Presence of metal objects in the body, implanted electronic devices, or any other counter indication for MRI.
Claustrophobia.
Major psychiatric disorders including mood, anxiety or psychotic disorders.
Cardiovascular or cerebrovascular disease, such as history of myocardial infarction, heart failure, angina, stroke, severe arrhythmias, or EKG abnormalities.
Kidney or liver disease.
Hypertension (resting systolic BP above 140 or diastolic above 85 mm Hg).

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Hypotension (resting systolic BP below 95 or diastolic below 60).
Use of any prescription or over-the-counter drug other than supplements and birth control.
History of or current neurological illnesses, such as stroke, seizures, dementia or organic brain syndrome.
Learning disability, attention deficit disorder, or any other condition that impedes memory and attention.
Glaucoma, organic pyloric stenosis, uremia or renal insufficiency.
Prostatic hypertrophy, bladder neck obstruction or urethral stricture.
Left-handed or ambidextrous.
Pregnant as determined by urine test, or breast-feeding.
History or current diagnosis of drug or alcohol abuse or dependence.
IQ < 85 as estimated by the WASI vocabulary subtest.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

National Institute on Drug Abuse, Intramural Research Program
Baltimore, Maryland, 21224
Maryland Psychiatric Research Center
Baltimore, Maryland, 21228

Other trials in United States

About this study

Official title: Nicotinic Modulation of the Default Network of Resting Brain Function

Many disorders where attentional problems are a hallmark, such as Alzheimer's disease and schizophrenia, display abnormal regulation of the so-called default network of resting brain function that maintains internally directed thought when the mind is free to wander. There is indication that nicotine may improve attention by aiding the deactivation of the default network, and this mechanism may be of therapeutic benefit for the above disease states. The current project aims at providing a proof of concept by demonstrating that nicotinic drugs modulate default network function. The nicotinic agonist nicotine is hypothesized to improve attention by facilitating the down-regulation of default network activity, and the nicotinic antagonist mecamylamine is hypothesized to impair attention by impeding the down-regulation of default network activity during attentional task performance.

Read the detailed description

This study only enrolls healthy non-smokers. Participants perform attention tasks while undergoing functional Magnetic Resonance Imaging on three separate days. Across the three days, three difference conditions are tested in a double-blind manner, in randomized order. In all test sessions, participants receive a skin patch and swallow a capsule. In one session, both are a placebo. In another, the patch is a low-dose nicotine patch, and the capsule is a placebo. In another session, the patch is a placebo and the capsule contains a low dose of mecamylamine.

Conditions: Magnetic Resonance Imaging, Cognition, Nicotine, Mecamylamine
Being tested: Placebo, Nicotine, Mecamylamine
Keywords: nicotine, mecamylamine, attention, default network, fMRI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Participants are administered a placebo patch and a placebo capsule
NicotineDrug
Also called Nicotine CQ
Participants are administered a nicotine patch (7 mg/24 hrs) and a placebo capsule
MecamylamineDrug
Participants are administered a placebo patch and a capsule containing 7.5 mg of mecamylamine

Study groups in NCT01223404
Study group	Role	What they receive
Placebo, Nicotine, Mecamylamine	Experimental	Participants undergo 3 test sessions: In the first session ("placebo"), a placebo patch and a placebo capsule is administered. In the second session ("nicotine"), a nicotine patch (7 mg/24 hrs) and a placebo capsule is administered. In the third session ("mecamylamine"), a placebo patch and a mecamylamine capsule is administered. Receives: Drug: Placebo; Drug: Nicotine; Drug: Mecamylamine
Nicotine, Placebo, Mecamylamine	Experimental	Participants undergo 3 test sessions: In the first session ("nicotine"), a nicotine patch and a placebo capsule is administered. In the second session ("placebo"), a placebo patch (7 mg/24 hrs) and a placebo capsule is administered. In the third session ("mecamylamine"), a placebo patch and a mecamylamine capsule is administered. Receives: Drug: Placebo; Drug: Nicotine; Drug: Mecamylamine
Placebo, Mecamylamine, Nicotine	Experimental	Participants undergo 3 test sessions: In the first session ("placebo"), a placebo patch and a placebo capsule is administered. In the second session ("mecamylamine"), a placebo patch (7 mg/24 hrs) and a mecamylamine capsule is administered. In the third session ("nicotine"), a nicotine patch and a placebo capsule is administered. Receives: Drug: Placebo; Drug: Nicotine; Drug: Mecamylamine
Nicotine, Mecamylamine, Placebo	Experimental	Participants undergo 3 test sessions: In the first session ("nicotine"), a nicotine patch and a placebo capsule is administered. In the second session ("mecamylamine"), a placebo patch (7 mg/24 hrs) and a mecamylamine capsule is administered. In the third session ("placebo"), a placebo patch and a placebo capsule is administered. Receives: Drug: Placebo; Drug: Nicotine; Drug: Mecamylamine
Mecamylamine, Placebo, Nicotine	Experimental	Participants undergo 3 test sessions: In the first session ("mecamylamine"), a placebo patch and a mecamylamine capsule is administered. In the second session ("placebo"), a placebo patch (7 mg/24 hrs) and a placebo capsule is administered. In the third session ("nicotine"), a nicotine patch and a placebo capsule is administered. Receives: Drug: Placebo; Drug: Nicotine; Drug: Mecamylamine
Mecamylamine, Nicotine, Placebo	Experimental	Participants undergo 3 test sessions: In the first session ("mecamylamine"), a placebo patch and a mecamylamine capsule is administered. In the second session ("nicotine"), a nicotine patch (7 mg/24 hrs) and a placebo capsule is administered. In the third session ("placebo"), a placebo patch and a placebo capsule is administered. Receives: Drug: Placebo; Drug: Nicotine; Drug: Mecamylamine

What is being measured

The primary outcome is the main question the study is designed to answer.

Reaction Time
average reaction time on cognitive task performed in the MR scanner
Measured: 1 day
Signal Detection Performance
Signal detection on cognitive tasks performed in the MR scanner. For the attention task, this represents the percentage of trials in which the participant responded when a signal was presented. In the working memory task (N-back task), this represents the percentage of all target sequences to which the participant responded.
Measured: 1 day
Default Network Activity
Cognitive task-induced default network deactivation, measured by functional Magnetic Resonance Imaging. The default network was probed by five pre-defined ROIs per hemisphere. Task-induced deactivation was averaged across all ROIs.
Measured: 1 day

Secondary outcomes (3)

Subjective State
End-of-session subjective state is measured by the Profile of Mood States (POMS). We utilize "Total Mood Disturbance" (TMD) as a summary measure, derived by adding the total scores on the five negative mood scales (tension, depression, anger, fatigue, confusion) and subtracting the score on the one positive mood scale (vigor). The theoretical range of the TMD scale is -32 to 228, with negative values indicating less mood disturbance, i.e., a more positive emotional state.
Measured: 1 day
Systolic Blood Pressure
Systolic blood pressure (mmHg)
Measured: Bi-hourly: prior to patch application, 2 hours, 4 hours, and 6 hours after, and after the MRI scan (~8 hours after patch application)
Diastolic Blood Pressure
Diastolic blood pressure in mmHg.
Measured: Bi-hourly: prior to patch application, 2 hours, 4 hours, and 6 hours after, and after the MRI scan (~8 hours after patch application).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010Sep 2013

First posted19 Oct 2010 (estimated)
Study startOct 2010
Primary completionSep 2013
Study completionSep 2013

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
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: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01223404
Sponsor's protocol ID: HP-00042696
Other IDs: R21DA027894
Status last verified: Aug 2019
First submitted: 13 Oct 2010
Last updated: 19 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Hahn B, Ross TJ, Yang Y, Kim I, Huestis MA, Stein EA. Nicotine enhances visuospatial attention by deactivating areas of the resting brain default network. J Neurosci. 2007 Mar 28;27(13):3477-89. doi: 10.1523/JNEUROSCI.5129-06.2007.
PubMed 17392464

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Magnetic Resonance Imaging trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nicotinic Modulation of the Default Network of Resting Brain Function
ClinicalTrials.gov ID: NCT01223404
Acronym / sponsor ID: HP-00042696
Conditions: Magnetic Resonance Imaging, Cognition, Nicotine, Mecamylamine
Keywords: nicotine, mecamylamine, attention, default network, fMRI
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Oct 2010 (actual)
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 19 Oct 2010 (estimated)
Results: Posted 25 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Placebo, Nicotine, Mecamylamine	Experimental	Drug: Placebo, Drug: Nicotine, Drug: MecamylamineParticipants undergo 3 test sessions: In the first session ("placebo"), a placebo patch and a placebo capsule is administered. In the second session ("nicotine"), a nicotine patch (7 mg/24 hrs) and a placebo capsule is administered. In the third session ("mecamylamine"), a placebo patch and a mecamylamine capsule is administered.
Nicotine, Placebo, Mecamylamine	Experimental	Drug: Placebo, Drug: Nicotine, Drug: MecamylamineParticipants undergo 3 test sessions: In the first session ("nicotine"), a nicotine patch and a placebo capsule is administered. In the second session ("placebo"), a placebo patch (7 mg/24 hrs) and a placebo capsule is administered. In the third session ("mecamylamine"), a placebo patch and a mecamylamine capsule is administered.
Placebo, Mecamylamine, Nicotine	Experimental	Drug: Placebo, Drug: Nicotine, Drug: MecamylamineParticipants undergo 3 test sessions: In the first session ("placebo"), a placebo patch and a placebo capsule is administered. In the second session ("mecamylamine"), a placebo patch (7 mg/24 hrs) and a mecamylamine capsule is administered. In the third session ("nicotine"), a nicotine patch and a placebo capsule is administered.
Nicotine, Mecamylamine, Placebo	Experimental	Drug: Placebo, Drug: Nicotine, Drug: MecamylamineParticipants undergo 3 test sessions: In the first session ("nicotine"), a nicotine patch and a placebo capsule is administered. In the second session ("mecamylamine"), a placebo patch (7 mg/24 hrs) and a mecamylamine capsule is administered. In the third session ("placebo"), a placebo patch and a placebo capsule is administered.
Mecamylamine, Placebo, Nicotine	Experimental	Drug: Placebo, Drug: Nicotine, Drug: MecamylamineParticipants undergo 3 test sessions: In the first session ("mecamylamine"), a placebo patch and a mecamylamine capsule is administered. In the second session ("placebo"), a placebo patch (7 mg/24 hrs) and a placebo capsule is administered. In the third session ("nicotine"), a nicotine patch and a placebo capsule is administered.
Mecamylamine, Nicotine, Placebo	Experimental	Drug: Placebo, Drug: Nicotine, Drug: MecamylamineParticipants undergo 3 test sessions: In the first session ("mecamylamine"), a placebo patch and a mecamylamine capsule is administered. In the second session ("nicotine"), a nicotine patch (7 mg/24 hrs) and a placebo capsule is administered. In the third session ("placebo"), a placebo patch and a placebo capsule is administered.

Who may qualify

Ages: 21 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Age 21 through 50.
Did not consume cigarettes, cigarillos, cigars, or other tobacco or nicotine-containing products more than 20 times in lifetime, and did not use any nicotine-containing product at all within the last two years.
Normal or corrected to normal vision (at least 20/80).

Key exclusion criteria (16 listed)

Presence of metal objects in the body, implanted electronic devices, or any other counter indication for MRI.
Claustrophobia.
Major psychiatric disorders including mood, anxiety or psychotic disorders.
Cardiovascular or cerebrovascular disease, such as history of myocardial infarction, heart failure, angina, stroke, severe arrhythmias, or EKG abnormalities.
Kidney or liver disease.

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
PlaceboParticipants are administered a placebo patch and a placebo capsule	Drug	Mecamylamine, Nicotine, Placebo, Mecamylamine, Placebo, Nicotine, Nicotine, Mecamylamine, Placebo, Nicotine, Placebo, Mecamylamine, Placebo, Mecamylamine, Nicotine, Placebo, Nicotine, Mecamylamine
NicotineAlso: Nicotine CQParticipants are administered a nicotine patch (7 mg/24 hrs) and a placebo capsule	Drug	Mecamylamine, Nicotine, Placebo, Mecamylamine, Placebo, Nicotine, Nicotine, Mecamylamine, Placebo, Nicotine, Placebo, Mecamylamine, Placebo, Mecamylamine, Nicotine, Placebo, Nicotine, Mecamylamine
MecamylamineParticipants are administered a placebo patch and a capsule containing 7.5 mg of mecamylamine	Drug	Mecamylamine, Nicotine, Placebo, Mecamylamine, Placebo, Nicotine, Nicotine, Mecamylamine, Placebo, Nicotine, Placebo, Mecamylamine, Placebo, Mecamylamine, Nicotine, Placebo, Nicotine, Mecamylamine

Primary outcome

Reaction Time
Time frame: 1 day
average reaction time on cognitive task performed in the MR scanner
Signal Detection Performance
Time frame: 1 day
Signal detection on cognitive tasks performed in the MR scanner. For the attention task, this represents the percentage of trials in which the participant responded when a signal was presented. In the working memory task (N-back task), this represents the percentage of all target sequences to which the participant responded.
Default Network Activity
Time frame: 1 day
Cognitive task-induced default network deactivation, measured by functional Magnetic Resonance Imaging. The default network was probed by five pre-defined ROIs per hemisphere. Task-induced deactivation was averaged across all ROIs.

3 secondary outcomes

Subjective State
Time frame: 1 day
Systolic Blood Pressure
Time frame: Bi-hourly: prior to patch application, 2 hours, 4 hours, and 6 hours after, and after the MRI scan (~8 hours after patch application)
Diastolic Blood Pressure
Time frame: Bi-hourly: prior to patch application, 2 hours, 4 hours, and 6 hours after, and after the MRI scan (~8 hours after patch application).

Results and safety

Results posted to the registry on 25 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo, Nicotine, Mecamylamine	4	4
Nicotine, Placebo, Mecamylamine	3	3
Placebo, Mecamylamine, Nicotine	4	4
Nicotine, Mecamylamine, Placebo	5	4
Mecamylamine, Placebo, Nicotine	2	2
Mecamylamine, Nicotine, Placebo	3	3

Primary outcome: Reaction Time

Time frame: 1 day. Mean (95% Confidence Interval). Unit: ms

Measure	Intervention: Placebo n = 18	Intervention: Nicotine n = 18	Intervention: Mecamylamine n = 18
Attention task reaction time	512 (485 to 539)	492 (464 to 520)	524 (489 to 559)
Working memory task reaction time	541 (516 to 566)	533 (508 to 558)	573 (537 to 609)

Population analysed: 18 healthy male and female adult non-smokers. Only study completers are included, due to the within-subject design.

Primary outcome: Signal Detection Performance

Time frame: 1 day. Mean (95% Confidence Interval). Unit: percentage of all targets

Measure	Intervention: Placebo n = 18	Intervention: Nicotine n = 18	Intervention: Mecamylamine n = 18
Attention task correct identifications	86.4 (81.4 to 91.4)	93.8 (90.1 to 97.5)	85.2 (79.7 to 90.7)
Working memory task correct detections	89.6 (88.4 to 90.8)	95.5 (94.9 to 96.1)	88.6 (87.9 to 89.3)

Population analysed: Healthy adult non-smokers (only study completers).

Primary outcome: Default Network Activity

Time frame: 1 day. Mean (95% Confidence Interval). Unit: percentage of task-induced signal change

Measure	Intervention: Placebo n = 18	Intervention: Nicotine n = 18	Intervention: Mecamylamine n = 18
Value	-0.29 (-0.41 to -0.17)	-0.24 (-0.39 to -0.09)	-0.21 (-0.33 to -0.09)

Population analysed: Healthy non-smokers (only study completers).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 day (on each of separate 3 test days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention: Placebo	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Intervention: Nicotine	0 of 21 (0%)	2 of 21 (9.5%)	0 of 21
Intervention: Mecamylamine	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17392464Hahn B, Ross TJ, Yang Y, Kim I, Huestis MA, Stein EA. Nicotine enhances visuospatial attention by deactivating areas of the resting brain default network. J Neurosci. 2007 Mar 28;27(13):3477-89. doi: 10.1523/JNEUROSCI.5129-06.2007.

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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, College Park

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nicotine and Mecamylamine in people with Magnetic Resonance Imaging and Cognition, run by University of Maryland, Baltimore at 2 sites 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 3 inclusion and 16 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 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 25 Jan 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?

Reaction Time (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01223404, which also lists 1 linked publication.

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 19 Aug 2019.