Oxytocin and Stress Response in Alcohol Use Disorder

NCT03610633 | Completed Phase 2 Results

• 1 other identifier: PRO 50913
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals with alcohol use disorder (AUD) will complete one functional Magnetic Resonance Imaging (fMRI) scanning visit. Prior to the scan, individuals will receive a nasal spray of either 24 international units (IU) of oxytocin (OT), or placebo (PBO). During the scan, they will perform the Montreal Imaging Stress Task (MIST), a social stress task. Subjective craving and anxiety data will be collected.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• Corticolimbic Functional Connectivity Based on fMRI Blood Oxygenation Level Dependent (BOLD) Response During the Stress Versus Neutral Conditions of the Montreal Imaging Stress Test Task Averaged Over the Second and Third Functional Runs

  Corticolimbic functional connectivity will be determined using psychophysiological interaction (PPI) modeling. The left and right amygdala will serve as seed regions. Connectivity of each seed region with the homologous orbitofrontal cortex region will be represented as a parameter estimate, yielding one parameter estimate for right amygdala-right orbitofrontal connectivity and one parameter estimate for left amygdala-left orbitofrontal connectivity per subject.

  60 minutes following medication (oxytocin or placebo)

Study Arms (2)

Oxytocin/alcohol use disorder

EXPERIMENTAL

Participants will receive 24 IU of oxytocin prior to completing fMRI scanning procedures.

Drug: Oxytocin

Placebo/Alcohol use disorder

PLACEBO COMPARATOR

Participants will receive placebo (saline solution) prior to completing fMRI scanning procedures.

Drug: Placebo

Interventions

Oxytocin DRUG

The neuropeptide oxytocin (OT) increases social approach, trust, and reduces anxiety to social stress.

Also known as: Pitocin

Oxytocin/alcohol use disorder

Placebo DRUG

Saline solution.

Placebo/Alcohol use disorder

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 21-40.
• Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
• Meets the DSM 5 criteria for current alcohol use disorder.
• Reports drinking on average, at least 20 standard alcoholic drinks per week for at least the past three months.
• Currently not engaged in, and does not want treatment for, alcohol related problems.
• Lives within 50 miles of the study site.
• Subjects must consent to random assignment.
• Able to maintain abstinence for two days (without the aid of detoxification medications) as determined by self report and breathalyzer measurements Subjects must also have a negative breathalyzer urine drug screen at the study visit.
• Subjects must consent to the study visit which includes an outpatient admission to the Addiction Sciences Division and completing one functional magnetic resonance imaging (fMRI) scanning session.

You may not qualify if:

• Currently meets DSM 5 criteria for any other psychoactive substance use disorder.
• Is determined
• Any psychoactive substance use (except marijuana and nicotine) within the last 30 days by self-report and urine drug screen. For marijuana, no use within the last seven days by verbal report and negative (or decreasing) urine THC levels.
• Meets DSM 5 criteria for current major depression, panic disorder, obsessive-compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders, eating disorders, and any other psychotic disorder or organic mental disorder.
• Has current suicidal ideation or homicidal ideation.
• Has the need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications and medications for ADHD.
• Is currently taking medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, topiramate).
• Has clinically significant medical problems such as cardiovascular, renal, GI, neurological (e.g. seizure disorder) or endocrine problems that would impair participation or limit medication ingestion.
• Has past history of alcohol related medical illness such as gastrointestinal bleeding, pancreatitis, peptic ulcer, hepatic cirrhosis or alcoholic hepatitis.
• Has hepatocellular disease indicated by elevations of SGPT (ALT) or SGOT (AST) greater than 2.5 times normal at screening.
• Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
• Has current charges pending for a violent crime (not including DUI related offenses).
• Does not have a stable living situation.
• Presence of ferrous metal in the body, as evidence by metal screening and self-report.
• Severe claustrophobia or morbid obesity that preclude placement in the MRI scanner.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Addiction Sciences Division-Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Laura Lohnes
• Organization: Medical University of South Carolina

lohnes@musc.edu

843-792-7709

Study Officials

• Jane Joseph, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: August 1, 2018
• Study Start: March 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 23, 2019
• Results First Posted: October 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)