[C-11]NOP-1A and Alcohol Use Disorder

Rajesh Narendran

Status and phase: Completed; Early Phase 1

Conditions: Alcohol Use Disorder

Treatments: Drug: NOP-1A; Radiation: [C-11]

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03448016

R01AA025247 (U.S. NIH Grant/Contract)

PRO16030103 & PRO13080387

Details and patient eligibility

About

The goal of this study is to compare [C-11]NOP-1A binding in recently abstinent alcohol use disorders and controls

Full description

This will allow for understanding brain stress and antistress mechanisms that underlie abuse of alcohol in humans

Enrollment: 54 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

[A] Alcohol use disorders (AUD)

Inclusion Criteria:

1. Males or Females
2. Fulfill DSM5 diagnosis for alcohol use disorder
3. Medically Healthy

Exclusion Criteria:

1. Pregnancy or lactation
2. Comorbid severe/major medical, psychiatric (such as bipolar and psychotic disorders, etc.,) and current comorbid drug use disorders (other than tobacco use and recreational marijuana use)
3. Metal implants or paramagnetic objects contained within the body which may interfere with MRI scans
4. Currently employed as a radiation worker, or participation in radiation drug research procedures within the previous year
5. Currently on any psychotropic medications that can influence nociceptin transmission in the brain

[B]Healthy controls

Inclusion Criteria:

1. Males or females
2. Absence of present or past psychiatric conditions (including alcohol or drug use disorders)
3. Medically Healthy

Exclusion Criteria:

1. Pregnancy of lactation
2. Medical, psychiatric or comorbid drug/alcohol use disorders
3. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
4. Currently employed as a radiation worker; or participation in radioactive drug research protocols within the previous year
5. Currently on any psychotropic medications that can influence nociceptin transmission in the brain
6. Family history of psychotic disorder, manic episode, drug and alcohol use disorder in first-degree relatives

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Alcohol use disorders

Experimental group

Description:

\[C-11\]NOP-1A PET Scan

Treatment:

Radiation: [C-11]

Drug: NOP-1A

Controls

Experimental group

Description:

\[C-11\]NOP-1A PET Scan

Treatment:

Radiation: [C-11]

Drug: NOP-1A