Can brain imaging unlock the secrets of opioid addiction?
NCT ID NCT07800520
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
Researchers at Yale University are using PET brain scans with a radioactive tracer called [11C]OMAR to measure CB1 receptor levels in people with opioid use disorder who are stabilized on buprenorphine, compared to healthy controls. The study aims to see if CB1 receptor availability differs between these groups and whether it relates to mood, stress, or relapse risk. Participants will undergo brain imaging and complete questionnaires about depression, anxiety, and stress. This is an early-stage study focused on understanding the brain's role in opioid addiction, not on testing a new treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [11C]OMAR, a radioactive tracer used in PET brain scans to visualize CB1 receptors
- What this could lead to
- If this study succeeds, it could clarify how opioid use disorder affects CB1 receptors in the brain, potentially guiding new treatments for opioid dependence and relapse prevention.
- What could go wrong
- This is an early-phase imaging study with a small number of participants, so findings may not apply broadly. The radioactive tracer involves radiation exposure, and results may not directly lead to new therapies.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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25 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: All * Normal screening bloodwork. * Adequate arterial access for placement of an arterial line and blood sampling per study protocol. OUD Participants: * Diagnosis of opioid use disorder (OUD) according to DSM-5 criteria. * Actively seeking treatment for OUD. * Willingness to initiate opioid agonist therapy (OAT) with buprenorphine. Healthy Controls: * Good general physical health. * No current or past diagnosis of any psychiatric or substance use disorders. Exclusion Criteria: All * Any current major medical condition that, in the opinion of the Principal Investigator, poses a risk for PET procedures. * Prior participation in research studies within the past year that would result in cumulative radiation exposure exceeding annual limits. * Presence of ferromagnetic metal in the body, pacemaker, or other contraindications to MRI. * Positive pregnancy test or current lactation. * History of neurological conditions, including stroke or seizure disorders. OUD Participants * Current or past diagnosis of a serious psychiatric disorder. * Current diagnosis of any substance use disorder other than nicotine or opioids. * Use of any substances within the past 30 days. * Current use of SSRIs or benzodiazepines or use within the past 30 days. * Previous enrollment in the main study. Healthy Controls: * Current or past diagnosis of any psychiatric disorder. * Current diagnosis of any substance use disorder (excluding nicotine). * Use of any substances within the past 30 days.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Connecticut Mental Health Center, Clinical Neuroscience Research Unit
New Haven, Connecticut, 06519, United States
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Other studies related to the condition(s) this trial covers.
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