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NCT Number: NCT07800520

Characterization of CB1 Receptors Using [11-C]OMAR in Opioid Use Disorder

The goals of this sub-study is to assess CB1R availability in early abstinent individuals with OUD (following opioid agonist therapy - OAT stabilization) and in matched healthy controls.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Connecticut Mental Health Center, Clinical Neuroscience Research Unit

New Haven, Connecticut, 06519, United States

Location contact

Abigail Dewey

CONTACT

[email protected]

475-441-4190

Anahita Bassir Nia, MD

PRINCIPAL_INVESTIGATOR

About this study

Investigators will use PET imaging to investigate CB1R availability in treatment-seeking individuals with OUD during the early phase of OAT, compared to healthy controls (HCs). Using PET imaging with the CB1R-specific radioligand [¹¹C]OMAR, investigators will assess CB1R availability in predefined brain regions. Investigators will characterize group differences in CB1R availability, evaluate the relationship between CB1R alterations and negative emotional states, including mood, anxiety, and perceived stress, as well as risk of opioid relapse (defined as time to first use of non-prescribed opioids) over a 90-day follow-up period.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[11C]OMAR

Drug

For each [11C]OMAR PET scan, up to 20 mCi of [11C]OMAR will be administered.

Other names: [11C] JHU75528

Primary outcomes

  1. CB1R Availability

    Time frame: Day 7

    To compare cortical CB1R availability (volume of distribution, mL/cm3) assessed using brain PET imaging in individuals diagnosed with opioid use disorder on chronic methadone maintenance vs. matched healthy controls.

  2. Mean Beck Depression Inventory (BDI) score

    Time frame: Days 7, 28, 49, 70, 90

    A 21-question self-report tool to assess depression symptoms. Total score range 0 to 63, higher scores indicating more severe symptoms.

  3. Mean Anxiety Inventory (BAI) score

    Time frame: Days 7, 28, 49, 70, 90

    A 21-question self-report tool to assess anxiety symptoms. Total score range 0 to 63, higher scores indicating more severe anxiety.

  4. Mean Perceived Stress Scale (PSS) score

    Time frame: Days 7, 28, 49, 70, 90

    The PSS is a 10-item self- report scale. PSS scores are obtained by reversing responses to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Total score range from 0-40 with higher scores indicate greater levels of stress.

  5. Mean Opioid Relapse days

    Time frame: Days 7, 14, 21, 28, 35, 42, 49, 56, 70, 77, 84, 90

    Mean Opioid Relapse days assessed using Timeline Follow Back (TLFB)

Study contacts

Contact information is provided by the study sponsor or research team.

Abigail Dewey

CONTACT

[email protected]

475-441-4190

Anahita Bassir Nia, MD

CONTACT

[email protected]

203-974-7540

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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