Cocaine Use DisorderNCT04721418
Aberrant Synaptic Plasticity in Cocaine Use Disorder: A 11C-UCB-J PET Study
An observational study of Cocaine Use Disorder and Healthy Controls, run by Yale University at 1 site in United States.
Trial summary
The purpose of this research study is to measure synaptic density in the brain comparing individuals with cocaine use disorder to healthy controls. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Use Disorder, Healthy Controls
- What is being tested?
- 11C-UCB-J
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2021to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: One group will have current Cocaine Use Disorder, the other group will be Healthy Controls
Who may be able to join
- Age 21-60 years
- Physically healthy by medical history, physical, neurological, ECG and laboratory examinations
- For females, a negative serum pregnancy test
- For CUD: DSM-5 criteria for Cocaine Use Disorder and positive urine toxicology showing recent use
- For HC: Negative urine toxicology
Who cannot join
- DSM-5 criteria for other substance use disorders (e.g., alcohol, opiates, 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/or uncontrolled medical or neurological illness
- Current use of psychotropic and/or potentially psychoactive prescription medications
- Medical contraindications to MRI procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
The purpose of this research study is to measure synaptic density in the brain comparing individuals with cocaine use disorder to healthy controls.
Read the detailed description
Healthy controls (HC) will be studied as outpatients and undergo one MRI and one 11C-UCB-J PET scan, along with neurocognitive tasks. Individuals with Cocaine Use Disorder (CUD) will complete the study as inpatients on our unit and undergo one MRI and two 11C-UCB-J PET scans, along with neurocognitive tasks. Participants will complete sleep studies (to evaluate sleep architecture); the first two nights after admission and the last two nights before discharge. Cocaine users will be asked to complete outpatient follow-ups twice a week for up to nine weeks following their inpatient stay.
- Conditions
- Cocaine Use Disorder, Healthy Controls
- Being tested
- 11C-UCB-J
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-UCB-JRadiation
11C-UCB-J PET scan
| Study group | Role | What they receive |
|---|---|---|
| Cocaine Use Disorder | Not described Receives: Radiation: 11C-UCB-J | |
| Healthy Control | Not described Receives: Radiation: 11C-UCB-J |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group (CUD vs. HC) comparisons in ACC.
Between-group comparisons of the fP-corrected total volume of distribution (VT/fP) in ACC.
Measured: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) comparisons in vmPFC.
Between-group comparisons of the fP-corrected total volume of distribution (VT/fP) in vmPFC.
Measured: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) comparisons in mOFC.
Between-group comparisons of the fP-corrected total volume of distribution (VT/fP) in mOFC.
Measured: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Secondary outcomes (12)
Within subjects (CUD group) comparisons in ACC.
Within subjects (CUD group) comparisons (i.e., baseline/pre-abstinence vs. after 3 weeks of inpatient abstinence) of the fP-corrected total volume of distribution (VT/fP) in ACC.
Measured: Baseline versus 3 weeks after.
Within subjects (CUD group) comparisons in vmPFC.
Within subjects (CUD group) comparisons (i.e., baseline/pre-abstinence vs. after 3 weeks of inpatient abstinence) of the fP-corrected total volume of distribution (VT/fP) in vmPFC.
Measured: Baseline versus 3 weeks after.
Within subjects (CUD group) comparisons in mOFC.
Within subjects (CUD group) comparisons (i.e., baseline/pre-abstinence vs. after 3 weeks of inpatient abstinence) of the fP-corrected total volume of distribution (VT/fP) in mOFC.
Measured: Baseline versus 3 weeks after.
Between-group (CUD vs. HC) of volume of distribution comparisons in ACC.
Between-group comparisons of volume of distribution (VT) in ACC.
Measured: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) of volume of distribution comparisons in vmPFC.
Between-group comparisons of volume of distribution (VT) in vmPFC.
Measured: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) of volume of distribution comparisons in mOFC.
Between-group comparisons of volume of distribution (VT) in mOFC.
Measured: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) comparisons of binding potential in ACC.
Between-group comparisons of binding potential (BPND) in ACC.
Measured: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) comparisons of binding potential in vmPFC.
Between-group comparisons of binding potential (BPND) in vmPFC.
Measured: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) comparisons of binding potential in mOFC.
Between-group comparisons of binding potential (BPND) in mOFC.
Measured: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) comparisons of gray matter volume in ACC.
Between-group comparisons of gray matter volume (GMV) in ACC.
Measured: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) comparisons of gray matter volume in vmPFC.
Between-group comparisons of gray matter volume (GMV) in vmPFC.
Measured: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) comparisons of gray matter volume in mOFC.
Between-group comparisons of gray matter volume (GMV) in mOFC.
Measured: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start20 Jul 2021
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Gustavo Angarita, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721418
- Sponsor's protocol ID
- 2000029552
- Other IDs
- 1R01DA052454-01A1
- Status last verified
- Aug 2026
- First submitted
- 14 Jan 2021
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aberrant Synaptic Plasticity in Cocaine Use Disorder: A 11C-UCB-J PET Study
- ClinicalTrials.gov ID
- NCT04721418
- Acronym / sponsor ID
- 2000029552
- Conditions
- Cocaine Use Disorder, Healthy Controls
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to measure synaptic density in the brain comparing individuals with cocaine use disorder to healthy controls.
Detailed description
Healthy controls (HC) will be studied as outpatients and undergo one MRI and one 11C-UCB-J PET scan, along with neurocognitive tasks. Individuals with Cocaine Use Disorder (CUD) will complete the study as inpatients on our unit and undergo one MRI and two 11C-UCB-J PET scans, along with neurocognitive tasks. Participants will complete sleep studies (to evaluate sleep architecture); the first two nights after admission and the last two nights before discharge. Cocaine users will be asked to complete outpatient follow-ups twice a week for up to nine weeks following their inpatient stay.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cocaine Use Disorder | – | Radiation: 11C-UCB-J |
| Healthy Control | – | Radiation: 11C-UCB-J |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- One group will have current Cocaine Use Disorder, the other group will be Healthy Controls
Key inclusion criteria (5 listed)
- Age 21-60 years
- Physically healthy by medical history, physical, neurological, ECG and laboratory examinations
- For females, a negative serum pregnancy test
- For CUD: DSM-5 criteria for Cocaine Use Disorder and positive urine toxicology showing recent use
- For HC: Negative urine toxicology
Key exclusion criteria (5 listed)
- DSM-5 criteria for other substance use disorders (e.g., alcohol, opiates, 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/or uncontrolled medical or neurological illness
- Current use of psychotropic and/or potentially psychoactive prescription medications
- Medical contraindications to MRI procedure
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 |
|---|---|---|
| 11C-UCB-J11C-UCB-J PET scan | Radiation | Cocaine Use Disorder, Healthy Control |
Primary outcome
Between-group (CUD vs. HC) comparisons in ACC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group comparisons of the fP-corrected total volume of distribution (VT/fP) in ACC.
Between-group (CUD vs. HC) comparisons in vmPFC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group comparisons of the fP-corrected total volume of distribution (VT/fP) in vmPFC.
Between-group (CUD vs. HC) comparisons in mOFC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group comparisons of the fP-corrected total volume of distribution (VT/fP) in mOFC.
12 secondary outcomes
Within subjects (CUD group) comparisons in ACC.
Time frame: Baseline versus 3 weeks after.
Within subjects (CUD group) comparisons in vmPFC.
Time frame: Baseline versus 3 weeks after.
Within subjects (CUD group) comparisons in mOFC.
Time frame: Baseline versus 3 weeks after.
Between-group (CUD vs. HC) of volume of distribution comparisons in ACC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) of volume of distribution comparisons in vmPFC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) of volume of distribution comparisons in mOFC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) comparisons of binding potential in ACC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) comparisons of binding potential in vmPFC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) comparisons of binding potential in mOFC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) comparisons of gray matter volume in ACC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) comparisons of gray matter volume in vmPFC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Between-group (CUD vs. HC) comparisons of gray matter volume in mOFC.
Time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
Related trials for Cocaine Use Disorder
Recruiting
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
Cocaine Use, Cocaine Dependence
Active, not recruitingPhase 2
An Open-Label Tirzepatide Trial for Comorbid Obesity and Stimulant Use Disorder
Obesity, Methamphetamine Use Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder
Cocaine Use Disorder, Cocaine Dependence
Not yet recruiting
Examination of Transcranial Focused Ultrasound on Brain Activity in Adults With Cocaine Use Disorder
Cocaine Use Disorder (CUD)
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.
Gustavo Angarita, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cocaine Use Disorder and Healthy Controls, 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Between-group (CUD vs. HC) comparisons in ACC. (time frame: CUD: After 3 weeks of inpatient abstinence. HC: At baseline as outpatient.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2026.