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Trial Outcomes & Findings for Imaging Synaptic Density in Cocaine and Opiate Addiction In Vivo Using 11UCB-J PET (NCT NCT03527485)

NCT ID: NCT03527485

Last Updated: 2024-07-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

90 minute scan

Results posted on

2024-07-16

Participant Flow

Participant milestones

Participant milestones
Measure
Opiate Use Disorder (OUD)
15 subjects meeting opiate dependence criteria will receive 11UCB-J PET Scan. 11UCB-J PET Scan: 11UCB-J PET Scan
Healthy Controls (HC)
26 healthy controls; no substance dependence or mental health issues 11UCB-J PET Scan. 11UCB-J PET Scan: 11UCB-J PET Scan
Overall Study
STARTED
15
26
Overall Study
COMPLETED
15
26
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Imaging Synaptic Density in Cocaine and Opiate Addiction In Vivo Using 11UCB-J PET

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Opiate Use Disorder (OUD)
n=15 Participants
15 subjects meeting opiate dependence criteria will receive 11UCB-J PET Scan. 11UCB-J PET Scan: 11UCB-J PET Scan
Healthy Controls (HC)
n=26 Participants
26 healthy controls; no substance dependence or mental health issues 11UCB-J PET Scan. 11UCB-J PET Scan: 11UCB-J PET Scan
Total
n=41 Participants
Total of all reporting groups
Age, Continuous
37.4 years
STANDARD_DEVIATION 6.5 • n=5 Participants
36.7 years
STANDARD_DEVIATION 10.6 • n=7 Participants
37.0 years
STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
7 Participants
n=7 Participants
12 Participants
n=5 Participants
Sex: Female, Male
Male
10 Participants
n=5 Participants
19 Participants
n=7 Participants
29 Participants
n=5 Participants
Race/Ethnicity, Customized
White (Non-Hispanic)
15 Participants
n=5 Participants
22 Participants
n=7 Participants
37 Participants
n=5 Participants
Race/Ethnicity, Customized
African American/Black (Non-Hispanic)
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic or Latino
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
Race/Ethnicity, Customized
Other or Unknown
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
Region of Enrollment
United States
15 participants
n=5 Participants
26 participants
n=7 Participants
41 participants
n=5 Participants

PRIMARY outcome

Timeframe: 90 minute scan

Population: All participants who underwent 11C-UCB-J PET and MRI scans

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.

Outcome measures

Outcome measures
Measure
Opiate Use Disorder (OUD)
n=15 Participants
15 subjects meeting opiate dependence criteria will receive 11UCB-J PET Scan. 11UCB-J PET Scan: 11UCB-J PET Scan
Healthy Controls (HC)
n=26 Participants
26 healthy controls; no substance dependence or mental health issues 11UCB-J PET Scan. 11UCB-J PET Scan: 11UCB-J PET Scan
11C-UCB-J PET Synaptic Density
Region of Interest: Ventral Striatum (VS)
4.01 unitless
Standard Deviation 0.70
4.52 unitless
Standard Deviation 0.53
11C-UCB-J PET Synaptic Density
Region of Interest: Prefrontal Cortex (PFC)
4.62 unitless
Standard Deviation 0.87
5.09 unitless
Standard Deviation 0.61

Adverse Events

Opiate Use Disorder (OUD)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Healthy Controls (HC)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gustavo A. Angarita, MD, MHS

Yale School of Medicine

Phone: (203) 974-7536

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place