[C-11]PiB PET Imaging in Alcohol Use Disorders

NCT03746366 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: PRO18080481R01AA025247
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether alcoholics (AUD) have a greater rate of amyloid positivity (ABeta+) compared to an age-matched cognitively normal control group (HC).

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• [C-11]PIB +

  positive/negative

  Baseline

Study Arms (2)

Alcohol use disorders

EXPERIMENTAL

\[C-11\]Pittsburgh Compound B (PiB) PET scan

Radiation: [C-11]; Drug: Pittsburgh Compound B

Healthy controls

EXPERIMENTAL

\[C-11\]Pittsburgh Compound B (PiB) PET scan

Radiation: [C-11]; Drug: Pittsburgh Compound B

Interventions

[C-11] RADIATION

Radiolabel

Alcohol use disorders; Healthy controls

Pittsburgh Compound B DRUG

Tracer

Alcohol use disorders; Healthy controls

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females between 40 and 65 years old
• Fulfill DSM-5 criteria for alcohol use disorder of at least moderate severity
• Current heavy drinking as defined in SAMHSA criteria (i.e., drinking 5 or more drinks on the same occasion on each of 5 or more days in the past 30 days)

You may not qualify if:

• DSM-5 schizophrenia, schizoaffective disorder, bipolar disorder (SCID-5) and prior history of developmental disorders, such as Autism, Down's Syndrome, Intellectual disability.
• A positive urine drug screen at screening for amphetamines, cocaine, methamphetamine, opioids, barbituates and PCP
• History of severe unstable medical or neurological illnesses that could affect neuropsychological testing
• History of cancer (other than skin or in situ prostate cancer) within the previous 5 years
• Currently pregnant or breastfeeding
• Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
• Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
• No first-degree relative with Alzheimer's disease or related dementias
• (B) Healthy Control Subjects (HC)
• (1) Males or females between 40 and 65 years old
• Current or past DSM-5 psychiatric and/or addictive disorders
• Current heavy drinking as defined in SAMHSA criteria
• History of severe unstable medical or neurological illnesses that could affect neuropsychological testing
• History of cancer (other than skin or in situ prostate cancer) within the previous 5 years
• Currently pregnant or breastfeeding

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Pittsbyurgh PET Facility

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Flanigan MR, Royse SK, Cenkner DP, Kozinski KM, Stoughton CJ, Himes ML, Minhas DS, Lopresti B, Butters MA, Narendran R. Imaging beta-amyloid (Abeta) burden in the brains of middle-aged individuals with alcohol-use disorders: a [11C]PIB PET study. Transl Psychiatry. 2021 May 1;11(1):257. doi: 10.1038/s41398-021-01374-y.

  PMID: 33934110 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

3-alpha-Hydroxysteroid Dehydrogenase (B-Specific); 2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

3-Hydroxysteroid Dehydrogenases; Hydroxysteroid Dehydrogenases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology and Psychiatry

Model Details: \[C-11\]PiB

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 19, 2018
• Study Start: December 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: December 13, 2024

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)