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Does Oxytocin Alter Tolerance to or Motivation for Alcohol

Primary Purpose

Alcohol Use Disorder

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Intranasal oxytocin

Intranasal placebo

About this trial

This is an interventional basic science trial for Alcohol Use Disorder focused on measuring Alcohol use disorder, Oxytocin, intranasal, Alcohol tolerance, Alcohol intake, Alcohol treatment, Alcohol, intravenous

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Clamp

Progressive work for alcohol

Arm Description

Clamped alcohol exposure, repeated tests of subjective and cognitive effects of alcohol, 2 sessions (intranasal oxytocin or placebo), double blind

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

Outcomes

Primary Outcome Measures

Subjective effects of alcohol

Difference between oxytocin compared to placebo sessions in tolerance to the subjective effects of alcohol as measured using a self-report questionnaire

Stop Signal Response task

Difference between oxytocin compared to placebo sessions in tolerance to the effects of alcohol on stop signal response times and performance

Stroop test

Difference between oxytocin compared to placebo sessions in tolerance to the effects of alcohol on stroop test response times and performance

Alcohol self-administration

Difference between oxytocin versus placebo sessions in motivation for alcohol as indicated by number of alcohol infusions earned, progressive ratio breakpoint, and/or breath alcohol concentration achieved.

Alcohol purchase task

Difference between oxytocin versus placebo sessions in motivation for alcohol as indicated by the maximum price subjects endorse.

Secondary Outcome Measures

Full Information

NCT ID

NCT05312008

First Posted

February 26, 2022

Last Updated

May 18, 2023

Sponsor

Indiana University

1. Study Identification

Unique Protocol Identification Number

NCT05312008

Brief Title

Does Oxytocin Alter Tolerance to or Motivation for Alcohol

Official Title

Does Oxytocin Alter Tolerance to Alcohol or Motivation for Alcohol in Heavy Drinking Human Subjects: Testing a Novel Anti-Addiction Mechanism

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 16, 2022 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This pilot study will seek evidence that oxytocin, compared to placebo, reverses tolerance and alcohol seeking in humans.

Detailed Description

This pilot study will seek evidence that intranasal oxytocin reverses 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder

Keywords

Alcohol use disorder, Oxytocin, intranasal, Alcohol tolerance, Alcohol intake, Alcohol treatment, Alcohol, intravenous

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

2 Arms; both 2 session parallel design

Masking

ParticipantInvestigator

Masking Description

The pharmacy will prepare the intranasal spray (both oxytocin and placebo) and deliver it in coded syringes to the lab. Investigators, laboratory staff and subjects will be unaware of the identity of the spray on session days. The pharmacy will provide the unmasking information after all sessions are completed..

Allocation

Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Clamp

Arm Type

Experimental

Arm Description

Clamped alcohol exposure, repeated tests of subjective and cognitive effects of alcohol, 2 sessions (intranasal oxytocin or placebo), double blind

Arm Title

Progressive work for alcohol

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Intranasal oxytocin

Intervention Description

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

Intervention Name(s)

Intranasal placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Subjective effects of alcohol

Description

Difference between oxytocin compared to placebo sessions in tolerance to the subjective effects of alcohol as measured using a self-report questionnaire

Time Frame