Does Oxytocin Alter Tolerance to or Motivation for Alcohol

NCT ID: NCT05312008

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-16
• Study Completion Date: 2023-12-21

Brief 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.

Detailed 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.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Clamp

Repeated subjective and cognitive tests during a 4 hour session that includes a baseline period, an oxytocin or placebo delivery, absorption and testing period, and a 2 hour alcohol clamp. Oxytocin or placebo were delivered intranasally in two sessions, scheduled 3-4 weeks apart, double blind.

Group Type: EXPERIMENTAL

Intranasal oxytocin

Intervention Type: DRUG

Initial dose 40 IU in 1 ml; 2 booster doses of 24 IU in 0.6 mls each, spaced about 1 hour apart

Intranasal placebo

Intervention Type: DRUG

Initial volume 1 ml; 2 booster volumes of 0.6 mls each, spaced about 1 hour apart

Progressive work for alcohol

Progressive work alcohol exposure, 2 sessions (intranasal oxytocin or placebo), double blind.

Note this Arm was not completed (see Overall Status for explanation of study termination)

Group Type: EXPERIMENTAL

Intranasal oxytocin

Intervention Type: DRUG

Initial dose 40 IU in 1 ml; 2 booster doses of 24 IU in 0.6 mls each, spaced about 1 hour apart

Intranasal placebo

Intervention Type: DRUG

Initial volume 1 ml; 2 booster volumes of 0.6 mls each, spaced about 1 hour apart

Interventions

Intranasal oxytocin

Initial dose 40 IU in 1 ml; 2 booster doses of 24 IU in 0.6 mls each, spaced about 1 hour apart

Intervention Type: DRUG

Intranasal placebo

Initial volume 1 ml; 2 booster volumes of 0.6 mls each, spaced about 1 hour apart

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Heavy alcohol drinkers.
• Able to understand/complete questionnaires and procedures in English.
• Have venous access sufficient to allow blood sampling.

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 drink alcohol
• Medical disorders or other conditions such as alcohol withdrawal seizures or delirium 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 to adversely 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 the PI.
• DSM 5 Disorders (other than alcohol) or current/history of neurological disease of cerebral origin, or head injury with > 20 min loss of consciousness, if determined by 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) or are at serious suicidal risk, by clinical judgment of the PI.
• Any condition for which the PI and investigative team determine it is unsafe or not prudent to enroll a participant.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Martin Plawecki

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin H Plawecki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Psychiatry, Indiana University School of Medicine

Locations

University Hospital

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

10002

Identifier Type: -

Identifier Source: org_study_id