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Radiopharmaceutical
Dopamine Signaling Study for Opioid Use Disorder
Phase < 1
Recruiting
Led By Gene-Jack Wang, 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
Awards & highlights
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.Check my eligibility
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.See study design
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 belowSelect...
I am 18-65, have a history of opioid abuse, and haven't used opioids or treatment meds in 3 months.
Select...
I am 18-65, with a history of opiate abuse, and have been on naltrexone for over a week.
Select...
I haven't regularly used opioids in the last 3 months.
Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
Find a Location
Who is running the clinical trial?
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Lead Sponsor
800 Previous Clinical Trials
1,362,697 Total Patients Enrolled
Gene-Jack Wang, M.D.Principal InvestigatorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
5 Previous Clinical Trials
301 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a healthy volunteer without major medical issues or specific conditions listed.Only individuals who have a certain medical condition can participate in this study.You can read and understand information about the study and agree to participate by signing a form.You have been diagnosed with Opiate Use Disorder.I am 18-65, have a history of opioid abuse, and haven't used opioids or treatment meds in 3 months.I am 18-80, with a history of opioid abuse for 3+ years, and currently on opioid therapy.You have a history of certain mental health disorders that require antipsychotic medications, or are currently receiving treatment for opioid addiction using specific medications. Additionally, you may be excluded if you have significant medical issues, have been exposed to radiation, are pregnant or breastfeeding, have certain eye conditions or difficulty lying flat, or are unable to communicate in English. Study investigators and staff are also not eligible to participate.I haven't taken OUD medications for at least 3 months.I am 18-65, with a history of opiate abuse, and have been on naltrexone for over a week.I am between 66-80 years old and understand I won't receive certain tests or treatments due to my age.You have been diagnosed with a moderate or severe opioid use disorder (OUD) through a clinical examination and medical history.I haven't regularly used opioids in the last 3 months.Participants with opioid use disorder (OUD) and co-occurring mental health or substance use disorders.You have to have used opioids for at least five days every week in the past, according to what you tell us.I am between 18 and 65 years old and can sign a consent form.You have a history of using opiate drugs for at least 3 years in the past, as reported by yourself.I am between 18 and 65 years old.
Research Study Groups:
This trial has the following groups:- Group 1: [11C]raclopride plus drug
- Group 2: [11C]raclopride plus placebo
- Group 3: [11C]NNC-112
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who meets the eligibility requirements for this medical research?
"This clinical trial is seeking 300 individuals that have been diagnosed with opioid use disorder and are between 18-80 years of age. Applicants must be able to provide written consent, meet the DSM-5 criteria for a moderate or severe OUD, show 3 months since their last regular opiate use (no more than 1x/week in past 3 months), demonstrate a minimum of three year history of past opiate abuse based on self-report, consume opioids at least 5 days per week as indicated by self-report, not currently taking medications for OUD and no regulary taken medication in the previous 3 months (methadone"
Answered by AI
Are elderly individuals being included in this experiment?
"The enrollment qualifications for this clinical trial necessitates that participants be between 18 and 80 years of age. There are 91 studies available to individuals under the legal adult age, while 410 research projects exist for elderly patients."
Answered by AI
Are participants currently being accepted for this experiment?
"Clinicaltrials.gov indicates that this medical trial has been ongoing since August 17th 2017, and the last update was made on December 1st 2022; thus, it is currently recruiting patients."
Answered by AI
What have been the outcomes of prior experiments utilizing [11C]raclopride in combination with pharmaceuticals?
"At present, two trials analyzing the efficacy of [11C]raclopride plus drug are taking place. Neither of these studies is in phase 3 yet; however, both have Bethesda, Maryland as their primary site with an additional 2 clinical sites involved."
Answered by AI
Could you please tell me what the upper limit is for participant enrollment in this clinical trial?
"Affirmative. Clinicaltrials.gov has evidence that this medical trial, originally posted on August 17th 2017, is actively seeking participants. Approximtely 300 individuals need to be enrolled from 1 site."
Answered by AI
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