Does Oxytocin Alter Tolerance to or Motivation for Alcohol

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05312008
• Other study ID #: 10002
• Status: Terminated
• Phase: Phase 2
• Start date: January 16, 2022
• Est. completion date: December 21, 2023

Study information

• Verified date: May 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 21, 2023
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• 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
• Intranasal placebo
Initial volume 1 ml; 2 booster volumes of 0.6 mls each, spaced about 1 hour apart

Locations

Country	Name	City	State
United States	University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo
Primary	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	2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo
Primary	Stroop test	Difference between oxytocin compared to placebo sessions in tolerance to the effects of alcohol on stroop test response times and performance	2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo
Primary	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.	2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo
Primary	Alcohol purchase task	Difference between oxytocin versus placebo sessions in motivation for alcohol as indicated by the maximum price subjects endorse.	2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo