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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Oxytocin and Stress Response in Alcohol Use Disorder

NCTNCT03610633 (opens ClinicalTrials.gov in a new tab)Other idPRO 50913
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
11 participants (actual)
Sponsor
Medical University of South Carolina · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Mar 2016
Primary completion
Sept 2018
Completion
Sept 2018
First posted
1 Aug 2018
Last update posted
23 Oct 2019
Conditions
Alcohol Use Disorder

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201720182019
  1. Ph 2

    Oxytocin and Stress Response in Alcohol Use Disorder

    NCT03610633

    Mar 2016 to Sept 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OxytocinDrug
  • PlaceboDrug

Arms2

  • Experimental

    Oxytocin/alcohol use disorder

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

  • Placebo comparator

    Placebo/Alcohol use disorder

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  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

    Time frame · 60 minutes following medication (oxytocin or placebo)

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 60 minutes following medication (oxytocin or placebo)

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

GroupValue (contrast of parameter estimates)Spread
Oxytocin/Alcohol Use Disorder-.12723.103532
Placebo/Alcohol Use Disorder-.04836.150718

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Oxytocin/Alcohol Use DisorderParticipants will receive 24 IU of oxytocin prior to completing fMRI scanning procedures. Oxytocin: The neuropeptide oxytocin (OT) increases social approach, trust, and reduces anxiety to social stress.0 / 50 / 50 / 5
Placebo/Alcohol Use DisorderParticipants will receive placebo (saline solution) prior to completing fMRI scanning procedures. Placebo: Saline solution.0 / 50 / 50 / 5

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Age 21-40. 2. Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments. 3. Meets the DSM 5 criteria for current alcohol use disorder. 4. Reports drinking on average, at least 20 standard alcoholic drinks per week for at least the past three months. 5. Currently not engaged in, and does not want treatment for, alcohol related problems. 6. Lives within 50 miles of the study site. 7. Subjects must consent to random assignment. 8. 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. 9. 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. Exclusion Criteria: 1. Currently meets DSM 5 criteria for any other psychoactive substance use disorder. 2. Is determined 3. 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. 4. 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. 5. Has current suicidal ideation or homicidal ideation. 6. Has the need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications and medications for ADHD. 7. Is currently taking medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, topiramate). 8. 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. 9. Has past history of alcohol related medical illness such as gastrointestinal bleeding, pancreatitis, peptic ulcer, hepatic cirrhosis or alcoholic hepatitis. 10. Has hepatocellular disease indicated by elevations of SGPT (ALT) or SGOT (AST) greater than 2.5 times normal at screening. 11. Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control. 12. Has current charges pending for a violent crime (not including DUI related offenses). 13. Does not have a stable living situation. 14. Presence of ferrous metal in the body, as evidence by metal screening and self-report. 15. Severe claustrophobia or morbid obesity that preclude placement in the MRI scanner. 16. History of head injury with \>2 minutes of unconsciousness.

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