Opiate DependenceNCT03527485
Imaging Synaptic Density in Cocaine and Opiate Addiction In Vivo Using 11UCB-J PET
A study testing 11UCB-J PET Scan in people with Opiate Dependence and Cocaine Dependence, run by Yale University at 1 site in United States.
Trial summary
This study aims to measure synaptic density in the brains (including in ventral striatum [VS] and medial prefrontal cortex [mPFC]) of abstinent subjects with Cocaine Use Disorder (CUD) or Opiate Use Disorder (OUD) as compared to healthy control (HC) subjects using 11C-UCB-J PET. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Opiate Dependence, Cocaine Dependence
- What is being tested?
- 11UCB-J PET Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 28 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 21-55 years;
- Voluntary, written, informed consent;
- Physically healthy by medical history, physical, neurological, ECG and laboratory examinations;
- DSM-5 criteria for Opiate Use Disorder;
- Documented evidence (by urine toxicology) of 2 weeks abstinence from cocaine and 4 weeks abstinence from opiates;
- For females, a negative serum pregnancy (HCG) test;
- Full scale and verbal IQs > 80 (Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV)).
Who cannot join
- A history of other substance dependence (e.g., alcohol, sedative hypnotics), except for nicotine;
- A primary DSM-5 Axis I major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) as determined by the Structured Clinical Interview for DSM-5 (SCID-5);
- A history of significant and uncontrolled medical (e.g., cardiovascular, diabetic/metabolic) or neurological (e.g., cerebrovascular, seizures, traumatic brain injury) illness;
- A history of seizures;
- Current use of psychotropic and/or potentially psychoactive prescription medications;
- Medical contraindications to participation in a magnetic resonance (MR) imaging procedure (e.g., ferromagnetic implants/foreign bodies, claustrophobia, cardiac pacemaker, prosthetic valve, otologic implant, etc.) as recorded on the MR safety sheet;
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- For females, physical or laboratory (HCG) evidence of pregnancy;
- PTT and PT/INR lab results not appropriate for arterial line placement;
- Taking anticoagulants;
- Being prescribed methadone/buprenorphine upon screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
CT Mental Health Center
New Haven, Connecticut, 06519
About this study
This study aims to measure synaptic density in the brains (including in ventral striatum [VS] and medial prefrontal cortex [mPFC]) of abstinent subjects with Cocaine Use Disorder (CUD) or Opiate Use Disorder (OUD) as compared to healthy control (HC) subjects using 11C-UCB-J PET. Subjects will undergo a single 11C-UCB-J (also known as 11C-APP311) PET scan.
This would be the very first to image synaptic density in human cocaine and opiate users, thereby testing whether altered synaptic density in the rodent brain is recapitulated in CUD and OUD humans. If confirmed, the current study would provide compelling clinical-translational support for an important pathophysiological mechanism of addiction - aberrant structural synaptic plasticity. As such, the current study has considerable potential for advancing the neurobiological understanding of human cocaine and opiate addiction.
Read the detailed description
This study aims to measure synaptic density in the brains (including in ventral striatum [VS] and medial prefrontal cortex [mPFC]) of abstinent subjects with Cocaine Use Disorder (CUD) or Opiate Use Disorder (OUD) as compared to healthy control (HC) subjects using 11C-UCB-J PET. Subjects will undergo a single 11C-UCB-J (also known as 11C-APP311) PET scan.
This would be the very first to image synaptic density in human cocaine and opiate users, thereby testing whether altered synaptic density in the rodent brain is recapitulated in CUD and OUD humans. If confirmed, the current study would provide compelling clinical-translational support for an important pathophysiological mechanism of addiction - aberrant structural synaptic plasticity. As such, the current study has considerable potential for advancing the neurobiological understanding of human cocaine and opiate addiction.
A separate protocol from the study team, identified by the ClinicalTrials.gov ID NCT04721418, is conducting a comprehensive investigation into the cocaine use disorder group. Therefore, data for participants with cocaine use disorder are not included in the results for the current registration.
- Conditions
- Opiate Dependence, Cocaine Dependence
- Being tested
- 11UCB-J PET Scan
- Medical subject headings
- Opioid-Related Disorders, Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11UCB-J PET ScanDiagnostic test
11UCB-J PET Scan
| Study group | Role | What they receive |
|---|---|---|
| Opiate Use Disorder (OUD) | Other | 30 subjects meeting opiate dependence criteria will receive 11UCB-J PET Scan. Receives: Diagnostic Test: 11UCB-J PET Scan |
| Healthy Controls (HC) | Other | 30 healthy controls; no substance dependence or mental health issues 11UCB-J PET Scan. Receives: Diagnostic Test: 11UCB-J PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
11C-UCB-J PET Synaptic Density
PET scan- Participants underwent a single 11C-UCB-J PET scan to obtain measures of synaptic density (BPND). Structural magnetic resonance imaging (MRI) scans were also obtained for anatomical registration/partial volume correction (PVC) with the iterative Yang (IY) algorithm. BPND is a unitless metric. The study aimed to explore synaptic density differences in subjects with opioid use disorder compared to a control group within the sample.
Measured: 90 minute scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start1 Jan 2019
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opiate DependenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527485
- Sponsor's protocol ID
- 2000021843
- Other IDs
- 1R21DA046030-01A1
- Status last verified
- Jun 2024
- First submitted
- 19 Apr 2018
- Last updated
- 16 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Innis RB, Cunningham VJ, Delforge J, Fujita M, Gjedde A, Gunn RN, Holden J, Houle S, Huang SC, Ichise M, Iida H, Ito H, Kimura Y, Koeppe RA, Knudsen GM, Knuuti J, Lammertsma AA, Laruelle M, Logan J, Maguire RP, Mintun MA, Morris ED, Parsey R, Price JC, Slifstein M, Sossi V, Suhara T, Votaw JR, Wong DF, Carson RE. Consensus nomenclature for in vivo imaging of reversibly binding radioligands. J Cereb Blood Flow Metab. 2007 Sep;27(9):1533-9. doi: 10.1038/sj.jcbfm.9600493. Epub 2007 May 9.
PubMed 17519979
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Synaptic Density in Cocaine and Opiate Addiction In Vivo Using 11UCB-J PET
- ClinicalTrials.gov ID
- NCT03527485
- Acronym / sponsor ID
- 2000021843
- Conditions
- Opiate Dependence, Cocaine Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Posted 16 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to measure synaptic density in the brains (including in ventral striatum [VS] and medial prefrontal cortex [mPFC]) of abstinent subjects with Cocaine Use Disorder (CUD) or Opiate Use Disorder (OUD) as compared to healthy control (HC) subjects using 11C-UCB-J PET. Subjects will undergo a single 11C-UCB-J (also known as 11C-APP311) PET scan.
This would be the very first to image synaptic density in human cocaine and opiate users, thereby testing whether altered synaptic density in the rodent brain is recapitulated in CUD and OUD humans. If confirmed, the current study would provide compelling clinical-translational support for an important pathophysiological mechanism of addiction - aberrant structural synaptic plasticity. As such, the current study has considerable potential for advancing the neurobiological understanding of human cocaine and opiate addiction.
Detailed description
This study aims to measure synaptic density in the brains (including in ventral striatum [VS] and medial prefrontal cortex [mPFC]) of abstinent subjects with Cocaine Use Disorder (CUD) or Opiate Use Disorder (OUD) as compared to healthy control (HC) subjects using 11C-UCB-J PET. Subjects will undergo a single 11C-UCB-J (also known as 11C-APP311) PET scan.
This would be the very first to image synaptic density in human cocaine and opiate users, thereby testing whether altered synaptic density in the rodent brain is recapitulated in CUD and OUD humans. If confirmed, the current study would provide compelling clinical-translational support for an important pathophysiological mechanism of addiction - aberrant structural synaptic plasticity. As such, the current study has considerable potential for advancing the neurobiological understanding of human cocaine and opiate addiction.
A separate protocol from the study team, identified by the ClinicalTrials.gov ID NCT04721418, is conducting a comprehensive investigation into the cocaine use disorder group. Therefore, data for participants with cocaine use disorder are not included in the results for the current registration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opiate Use Disorder (OUD) | Other | Diagnostic Test: 11UCB-J PET Scan30 subjects meeting opiate dependence criteria will receive 11UCB-J PET Scan. |
| Healthy Controls (HC) | Other | Diagnostic Test: 11UCB-J PET Scan30 healthy controls; no substance dependence or mental health issues 11UCB-J PET Scan. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 21-55 years;
- Voluntary, written, informed consent;
- Physically healthy by medical history, physical, neurological, ECG and laboratory examinations;
- DSM-5 criteria for Opiate Use Disorder;
- Documented evidence (by urine toxicology) of 2 weeks abstinence from cocaine and 4 weeks abstinence from opiates;
Key exclusion criteria (10 listed)
- A history of other substance dependence (e.g., alcohol, sedative hypnotics), except for nicotine;
- A primary DSM-5 Axis I major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) as determined by the Structured Clinical Interview for DSM-5 (SCID-5);
- A history of significant and uncontrolled medical (e.g., cardiovascular, diabetic/metabolic) or neurological (e.g., cerebrovascular, seizures, traumatic brain injury) illness;
- A history of seizures;
- Current use of psychotropic and/or potentially psychoactive prescription medications;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 11UCB-J PET Scan11UCB-J PET Scan | Diagnostic test | Healthy Controls (HC), Opiate Use Disorder (OUD) |
Primary outcome
11C-UCB-J PET Synaptic Density
Time frame: 90 minute scan
PET scan- Participants underwent a single 11C-UCB-J PET scan to obtain measures of synaptic density (BPND). Structural magnetic resonance imaging (MRI) scans were also obtained for anatomical registration/partial volume correction (PVC) with the iterative Yang (IY) algorithm. BPND is a unitless metric. The study aimed to explore synaptic density differences in subjects with opioid use disorder compared to a control group within the sample.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17519979Innis RB, Cunningham VJ, Delforge J, Fujita M, Gjedde A, Gunn RN, Holden J, Houle S, Huang SC, Ichise M, Iida H, Ito H, Kimura Y, Koeppe RA, Knudsen GM, Knuuti J, Lammertsma AA, Laruelle M, Logan J, Maguire RP, Mintun MA, Morris ED, Parsey R, Price JC, Slifstein M, Sossi V, Suhara T, Votaw JR, Wong DF, Carson RE. Consensus nomenclature for in vivo imaging of reversibly binding radioligands. J Cereb Blood Flow Metab. 2007 Sep;27(9):1533-9. doi: 10.1038/sj.jcbfm.9600493. Epub 2007 May 9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 11UCB-J PET Scan in people with Opiate Dependence and Cocaine Dependence, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
11C-UCB-J PET Synaptic Density (time frame: 90 minute scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03527485, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.