Understanding Dopamine Mechanisms in Cocaine Addiction Using AMPT and Methylphenidate With [11C]RAC/[11C]PHNO PET
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ClinicalTrials.gov Identifier: NCT02152670 |
Recruitment Status :
Terminated
(Study drug became unaffordable for the purposes of the research.)
First Posted : June 2, 2014
Results First Posted : October 22, 2020
Last Update Posted : February 25, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cocaine Dependence | Drug: Methylphenidate Drug: Alpha Methyl Para Tyrosine (AMPT) Other: [11C]PHNO Other: [11C]raclopride | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | Non-Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Study Start Date : | May 2014 |
Actual Primary Completion Date : | June 9, 2014 |
Actual Study Completion Date : | June 9, 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Baseline
Subjects will receive 2 baseline PET scans with the radioligands (11C)(+)PHNO and (11C)(+)raclopride
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Other: [11C]PHNO Other: [11C]raclopride |
Experimental: Dopamine Release
Subjects will receive 1 PET scan following a PO dose of 60mg of methylphenidate to facilitate dopamine release with the radioligand (11C)(+)PHNO
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Drug: Methylphenidate Other: [11C]PHNO |
Experimental: Endogenous Dopamine
Subjects will receive 2 PET scans following 48 hours of dopamine depletion via AMPT with the radioligands (11C)(+)PHNO and (11C)(+)raclopride
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Drug: Alpha Methyl Para Tyrosine (AMPT) Other: [11C]PHNO Other: [11C]raclopride |
- BPND [ Time Frame: 2 weeks ]BPND is a measure of dopamine receptor availability

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- age 18 - 50 years,
- voluntary, written, informed consent,
- physically healthy by medical history, physical, neurological, ECG, and laboratory examinations,
- for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (B-HCG) test.
- English speaking
- No other major Axis DSM-IV diagnosis present, besides required as below
Inclusion criteria for cocaine dependent:
- DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
- recent street cocaine use,
- intravenous and/or smoked (crack/ freebase) use,
- positive urine toxicology screen for cocaine,
Inclusion criteria for healthy controls:
- No current, or history of, any DSM-IV diagnosis
- No first-degree relative with history of psychotic, mood, or anxiety disorder
Exclusion Criteria:
- medical contraindications to AMPT administration (e.g., known sensitivity/reaction to AMPT);
- medical contraindications to MPH administration (e.g., history of cardiac problems, seizures, etc.)
- drug or alcohol dependence (except nicotine),
- a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine or pathological gambling
- positive answers on the cardiac screening questionnaire that may place the subject at higher risk, as determined by cardiologist review of both the questionnaire responses and screening ECG
- current use of psychotropic and/or potentially psychoactive prescription medication,
- physical or laboratory (B-HCG) evidence of pregnancy,
- clotting disorders or recent anticoagulant therapy,
- MRI-incompatible implants and other contraindications for MRI (i.e., aneurysm clip, metal fragments, internal electrical devices such as a cochlear implant, spinal cord stimulator or pacemaker),
- history of claustrophobia or feeling of inability to lie still on his back for the PET or MRI scans,
- history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over Radioactive Drug Research Committee (RDRC) limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year.
- donation or loss of 550 mL of blood or more (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to the first dose of study drug.
- use any prescription medications and/or over-the-counter medications, vitamins and/or herbal supplements within 2 weeks prior to study and for the duration of the study without approval from the study doctor.
- eat grapefruit or grapefruit products, and drink alcohol, and anything containing caffeine 3 days before study and during study
- For CD subjects, < 1 year of cocaine dependence, .
- Subjects with current, past, or anticipated exposure to radiation in the workplace.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152670
United States, Connecticut | |
Connecticut Mental Health Center | |
New Haven, Connecticut, United States, 06519 |
Principal Investigator: | Robert Malison, MD | Yale University |
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT02152670 |
Other Study ID Numbers: |
1403013567 |
First Posted: | June 2, 2014 Key Record Dates |
Results First Posted: | October 22, 2020 |
Last Update Posted: | February 25, 2021 |
Last Verified: | February 2021 |
Cocaine-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Raclopride Methylphenidate alpha-Methyltyrosine Central Nervous System Stimulants Physiological Effects of Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Enzyme Inhibitors |