Does Oxytocin Alter Tolerance to or Motivation for Alcohol

Indiana University

Status and phase: Terminated; Phase 2

Conditions: Alcohol Use Disorder

Treatments: Drug: Intranasal placebo; Drug: Intranasal oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT05312008

10002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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6 participants in 2 patient groups

Clamp

Experimental group

Description:

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.

Treatment:

Drug: Intranasal placebo

Drug: Intranasal oxytocin

Progressive work for alcohol

Experimental group

Description:

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)

Treatment:

Drug: Intranasal placebo

Drug: Intranasal oxytocin