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Dopamine Rhythms in Health and Addiction

NCT02233829 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2024-04-24

No results posted yet for this study

Summary

Background:

\- Dopamine is a chemical signal linked to the rewarding effects of drugs. Certain genes make these effects sensitive to the time of day they are taken. Cocaine can affect these genes in the brain. Researchers want to measure brain dopamine at different times of day.

Objectives:

\- To look for changes to a person s biological clock in the function of the dopamine reward system. To test if cocaine disrupts this.

Eligibility:

* Adults age 21-55 with a cocaine use disorder.
* Healthy volunteers age 21-55.

Design:

* Participants will be screened with medical history, physical exam, interview, and blood and urine tests. Their breath will be tested for alcohol and recent smoking.
* Participants will have 3 overnight clinic visits.
* Visit 1: They will have blood and urine collected and a heart test.
* A plastic tube (catheter) will be placed into a vein in each arm by needle.
* Participants will have a PET scan in a donut-shaped machine. They will lie on a bed that slides in and out of it, wearing a cap. A radiotracer (measures dopamine) and a drug (blocks dopamine removal) will be injected via catheter. Vital signs will be measured and blood will be drawn throughout.
* Visit 2: repeats Visit 1, except at night.
* Visit 3, participants will have urine collected.
* They will have MRI scans in a metal cylinder surrounded by a magnetic field. They will lie on a table that slides in and out of it, with a coil over their head.
* Participants may answer questions, take computer or paper tests, and perform simple actions.
* For 1 week, participants will wear a wrist device that measures daily activity.

Conditions

  • Cocaine Abuse

Interventions

DRUG

Brain Dopamine Reactivity

IV methylphenidate, used under IND #124, 912 is injected into the subject s bloodstream to be used in conjunction with PET imaging to show displacement of \[11C\]raclopride.

RADIATION

Brain Dopamine Receptor

The radiotracer \[11C\] raclopride is used for imaging dopamine receptors and dopamine release.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    lead NIH

Principal Investigators

  • Gene-Jack Wang, M.D. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-23
Primary Completion
2024-04-23
Completion
2024-04-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02233829 on ClinicalTrials.gov