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Protocol Details

Dopaminergic Modulation of Brain Activation Using Simultaneous PET/Pharmacological MRI

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-AA-0178

Sponsoring Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 55

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women and Fetuses;
Children

Special Instructions

Currently Not Provided

Keywords

Pharmacological MRI;
C-11 Raclopride;
PET Imaging;
Neuropsychological Testing

Recruitment Keyword(s)

None

Condition(s)

Normal Physiology

Investigational Drug(s)

iv Methylphenidate
[11C]raclopride

Investigational Device(s)

None

Intervention(s)

Drug: Oral Methylphenidate followed by IV placebo
Drug: Oral placebo followed by IV Methylphenidate
Other: Oral Placebo followed by IV Placebo

Supporting Site

National Institute on Alcohol Abuse and Alcoholism

Background:

Dopamine (DA) is a chemical signal in the brain linked to learning, memory, and habits. Stimulant drugs like methylphenidate can increase DA in the brain. Researchers want to measure DA with and without this drug. They want to learn how methylphenidate and brain dopamine affect body responses, mood, and thinking.

Objective:

To better understand the role of dopamine in the brain and the effects of methylphenidate.

Eligibility:

Adults ages 18-55 who have used alcohol or stimulant drugs but have no drug dependence.

Design:

Participants will be screened with:

-Physical exam

-Question about medical, psychiatric, and alcohol and drug use history

-Questions to see if it s safe to have a PET/MRI scan

-Blood and urine tests

-Breath test for alcohol

Participants will have 3 or 4 study visits. At each visit they will have:

-Urine and breath tested for alcohol and drugs

-A thin plastic tube (catheter) inserted in each arm by needle

-A small amount of radioactive chemical injected through the catheter.

-PET/MRI scan. Participants will lie still on a table that slides in and out of a metal cylinder surrounded by a strong magnetic field. Their vital signs will be monitored. They will get earmuffs for loud noises. Before the scan, participants will get the study drug or placebo through the catheter. They may also get a sugar pill (placebo). They will get a small meal and have blood drawn.

- Tests of memory, attention, and thinking.

Participants will wear an activity monitor on the wrist for one week.

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Eligibility

INCLUSION CRITERIA:

Healthy Volunteer Participants

-Males or females between 18 and 55 years of age.

-Ability to provide written informed consent.

-Willing to abstain from drug use on scheduled testing days.

-Have or had any prior experience with alcohol use or stimulant drugs including cocaine, methylphenidate, amphetamine or methamphetamine, diet pills (prescription or over the counter), caffeine, and others but did not have a substance use disorder.

EXCLUSION CRITERIA:

-Pregnant or breastfeeding. Females of childbearing potential must have negative urine pregnancy test and not be currently breastfeeding. Postmenopausal or surgically sterile (tubal ligation or hysterectomy) females satisfy these criteria.

-Unwilling or unable to refrain from use within 24 hours of scheduled study procedures: psychoactive medications or medication that may affect study results (e.g., antibiotics (must finish course at least 24 hours prior to a scheduled procedure), antidiarrheal preparations, anti-inflammatory drugs [systemic corticosteroids are exclusionary], anti-nausea, cough/cold preparations) (self-report, medical history). The following medications are allowable for entry on this study: analgesics (non-narcotic); antacids; antiasthma agents that are not systemic corticosteroids; antifungal agents for topical use; antihistamines (non-sedating); H2-Blockers/PPI (proton pump inhibitors); laxatives. The use of antihyperlipidemics and/or diuretics are permitted if they have been taken for at least 1 month before procedure visits and dose has been stabilized. The episodic use of benzodiazepines such as alprazolam (Xanax), diazepam (Valium) and lorazepam (Ativan), will not exclude participants from this study unless they have been taken within the last 24 hours prior to the study.

-The following current chronically used medications are exclusionary from the study: stimulant or stimulant-like medications (amphetamine, methylphenidate, modafinil); analgesics containing narcotics; anorexics (sibuteramine); antianginal agents; antiarrhythmics; antiasthma agents that are systemic corticosteroids; antibiotics; anticholinergics; anticoagulants; anticonvulsants; antidepressants; antidiarrheal preparations; antifungal agents (systemic); antihistamines (sedating); antihypertensives; anti-inflammatory drugs (systemic); antineoplastics; antiobesity; antipsychotics; antivirals (except for treatment of HSV with agents without CNS activity, e.g. acyclovir, ganciclovir, famciclovir, valacyclovir); anxiolytics (benzodiazepine or barbiturates); hormones (exceptions: thyroid hormone replacement, oral contraceptives, and estrogen replacement therapy); insulin; lithium; muscle relaxants; psychotropic drugs not otherwise specified (nos) including herbal products (no drugs with psychomotor effects or with anxiolytics, stimulant, antipsychotic, or sedative properties); sedatives/hypnotics. Note that nicotine and/or caffeine use will not exclude participants.

-Current or past DSM-IV or DSM-5 diagnosis of a psychiatric disorder as determined by history and clinical exam including substance use disorder (except for nicotine/caffeine), alcohol use disorder (or alcohol dependence, if assessed using DSM-IV) anxiety disorder or panic attacks. Those with a binge drinking history in the last 10 years will also be excluded. Past history of a mental disorder as defined by DSM-IV or DSM-5 will be excluded only if it required hospitalization (any length), or chronic medication management (more than 4 weeks), and that could impact brain function at the time of the study. Binge drinkers are those who being female consume 4 or more drinks and males 5 or more drinks in one occasion at least once a month.

-Major medical problems that can impact brain function at the time of the scan (including but not limited to HIV; glaucoma, central nervous system including seizures and psychosis; cardiovascular including hypertension and arrhythmias; metabolic, autoimmune, endocrine) as determined by history and clinical exam.

-Any clinically significant laboratory finding as determined during the screening procedures.

-Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that, with the exposure from this study, would exceed NIH annual research limits.

-Head trauma with loss of consciousness for more than 30 minutes.

-Presence of ferromagnetic objects in the body that are contraindicated for PET/phMRI of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments), fear of enclosed spaces, or other standard contraindication to MRI/MRS (elf-report checklist).

-Cannot lie comfortably flat on back for up to 2 hours in the PET/phMRI scanner.

-Body weight > 204 kg (> 450 lbs).

-Allergy to methylphenidate.

-Clinically significant EKG abnormalities. Clinically significant findings on EKG will be assessed by the Medical Advisory Investigator on the study or through a cardiology consult. EKG reviews are documented in CRIS.

-History of glaucoma as determined by medical history.

-NIH employees who are study investigators, as well as their superiors, subordinates and immediate family members (adult children, spouses, parents, siblings).

--Subjects will not be excluded from enrollment in this study if their urine test is positive for drugs. However, if they test positive on scheduled study procedure days involving study imaging and neuropsychological testing, the procedures will be postponed and rescheduled. We will allow for up to 3 rescheduled study days that were the result of positive urine drug screens. If the drug test is positive on the third rescheduled visit, the participant will be withdrawn from the study.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Dardo G. Tomasi
National Institute on Alcohol Abuse and Alcoholism (NIAAA)



Dardo G. Tomasi
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health
Building 10
Room B2L304
10 Center Drive
Bethesda, Maryland 20892
(301) 496-1589
dardo.tomasi@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03326245

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