Does Oxytocin Alter Tolerance to or Motivation for Alcohol

Last updated: February 11, 2025
Sponsor: Indiana University
Overall Status: Terminated

Phase

2

Condition

Alcohol Use Disorder

Substance Abuse

Addictions

Treatment

Intranasal placebo

Intranasal oxytocin

Clinical Study ID

NCT05312008
10002
  • Ages 21-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This pilot study is intended to demonstrate feasibility and acquire preliminary data. If successful, this data could support a future project studying the effect of oxytocin on tolerance and alcohol seeking in humans.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Heavy alcohol drinkers.

  • Able to understand/complete questionnaires and procedures in English.

  • Have venous access sufficient to allow blood sampling.

Exclusion

Exclusion Criteria:

  • Latex allergy.

  • Nasal condition that compromises delivery and/or absorption of intra-nasal oxytocin

  • Pregnant or breast-feeding women.

  • Desire to be treated for any substance use disorder or court ordered to not drinkalcohol

  • Medical disorders or other conditions such as alcohol withdrawal seizures ordelirium tremens that may influence study outcome or participant safety.

  • Positive urine drug screen for amphetamines/ methamphetamines, barbiturates,benzodiazepines, cocaine, opiates, or phencyclidine if determined by the PI toadversely affect participant safety or data integrity.

  • Medications (past 30 days) that could influence participant safety or data integrity (e.g. antidepressants, antipsychotics, benzodiazepines, etc.) as determined by thePI.

  • DSM 5 Disorders (other than alcohol) or current/history of neurological disease ofcerebral origin, or head injury with > 20 min loss of consciousness, if determinedby the PI to affect participant safety or data integrity.

  • Positive breath alcohol reading at beginning of the experimental session.

  • Actively suicidal (for example, any current suicidal intent, including a plan) orare at serious suicidal risk, by clinical judgment of the PI.

  • Any condition for which the PI and investigative team determine it is unsafe or notprudent to enroll a participant.

Study Design

Total Participants: 6
Treatment Group(s): 2
Primary Treatment: Intranasal placebo
Phase: 2
Study Start date:
January 16, 2022
Estimated Completion Date:
December 21, 2023

Study Description

This pilot study is designed to demonstrate feasibility and provide preliminary data supporting use of intranasal oxytocin in treatment of alcohol use disorders. Specifically, experiments are planned to test the ability of oxytocin to reverse tolerance and alcohol seeking in humans by employing state-of-the-art computer-assisted intravenous alcohol administration. Two separate experiments will be run. In the first, tolerance will be assessed using sensitive tests of subjective response and cognitive function during an intravenous infusion that maintains a steady breath and therefore brain exposure to alcohol. In the second, an intravenous alcohol self-administration paradigm that requires increasing effort for each additional infusion will be used to assess change in motivation for alcohol. Demonstrating that oxytocin (compared to placebo) worsens test performances in alcohol-dependent individuals and/or reduces the compulsive drive to self-administer alcohol would be strong evidence for its potential to treat alcohol use disorders.

Connect with a study center

  • University Hospital

    Indianapolis, Indiana 46202
    United States

    Site Not Available

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