Phase 1
Completed N=22
Dopaminergic Modulation of Brain Activation Using Simultaneous PET/Pharmacological MRI
Normal Physiology
Source: ClinicalTrials.gov NCT03326245 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: The Standardized Uptake Value Ratio (SUVR) for [11C]Raclopride in Putamen — 4.49; 4.39; 4.87 SUV Ratio (SUVR)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Standardized Uptake Value Ratio (SUVR) for [11C]Raclopride in Putamen |
4.49; 4.39; 4.87 | — |
| PRIMARY Percent BOLD Signal Change in the Anterior Cingulum |
-0.13; 1.210; -0.001 | — |
| PRIMARY The Temporal Correlation Between BOLD(t) and SUVR(t) Change |
.023; .556 | — |
Eligibility Criteria
- 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/proton pump inhibitors (PPI); 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 (sibutramine); 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 Diagnostic and Statistical Manual (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. 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.
- Those with a binge drinking history every month continuously for the last 10 years will also be excluded. Binge drinkers are those who being female consume 4 or more drinks and males consume 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 in
Data sourced from ClinicalTrials.gov (NCT03326245). 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.