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Radiopharmaceutical

Dopamine Signaling Study for Opioid Use Disorder

Phase < 1

Recruiting

Led By Nora Volkow, M.D.

Research Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

MAT- OUD Participants: Males or females between 18 and 65 years of age, ability to provide written informed consent, DSM-5 diagnosis of a moderate or severe OUD, minimum of 3 months since last regular use of opioids, minimum 3 year history of past opiate abuse, must have consumed opiates at least 5 days per week, currently not receiving medications for OUD and a minimum of 3 months since last regularly taking medications for OUD

Naltrexone OUD Participants: Males or females between 18 and 65 years of age, ability to provide written informed consent, DSM-5 diagnosis of a moderate or severe OUD, active or non-active abuse of opiates, minimum 3 year history of opiate abuse, must have consumed at least 5 days per week, receiving naltrexone treatment for their OUD and must have taken at least one week before imaging study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study

Summary

This trial is testing if a decrease in dopamine affects self-control and increases impulsiveness in people with opiate use disorder.

Who is the study for?

Adults aged 18-65 with moderate to severe opioid use disorder (OUD) who haven't used opioids regularly for at least 3 months, or those on opioid agonist therapy. Healthy volunteers of the same age range can also participate. Exclusions include major medical issues, certain psychiatric disorders, pregnancy, and inability to lie flat or have an MRI.

What is being tested?

The study is examining how opioid addiction affects dopamine in the brain using PET scans with radioactive chemicals and MRIs. Participants will receive either a placebo or a drug alongside [11C]raclopride or [11C]NNC-112 to measure brain activity related to self-control and impulsiveness.

What are the potential side effects?

Possible side effects may include discomfort from lying still during scans, reactions to the radioactive chemical such as nausea or headache, anxiety from being in a confined space during MRI, and any potential but unspecified side effects from the study drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18-65, have a history of opioid abuse, and haven't used opioids or treatment meds in 3 months.

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I am 18-65, with a history of opiate abuse, and have been on naltrexone for over a week.

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I haven't regularly used opioids in the last 3 months.

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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of study

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Differences in D1R to D2R striatal ratio and in DA release between participants with an OUD and controls and between MAT+, naltrexone, and MAT- groups.

Secondary study objectives

1) To assess the impact of disruptions on striatal D1R to D2R availability on: DA release; Function of brain reward and control networks; Behavior.2) To assess if DA increases as achieved with oral MP influence the brain functional measure...

2) To assess if DA increases as achieved with oral MP influence the brain functional measures.

3) To assess if there is recovery after protracted treatment (comparing treated and non-treated) by repeating fMRI at 6 month follow-up.

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: [11C]raclopride plus drugActive Control2 Interventions

Methylphenidate 60 mg. po will be given 60 minutes prior to \[11C\]raclopride scan to measure striatal dopamine release. MRI scan to follow end of PET scan. Subject blind as to drug administration.

Group II: [11C]raclopride plus placeboPlacebo Group2 Interventions

Placebo (po) will be given 60 minutes prior to \[11C\]raclopride scan to measure baseline dopamine D2 receptors. MRI scan to follow end of PET scan. Subject blind as to drug administration.

Group III: [11C]NNC-112Placebo Group1 Intervention

\[11C\]NNC-112 PET scan obtained without any drug intervention to measure dopamine D1 receptors. Blind N/A

0 / 4Eligibility criteria met