Clinical trial NCT05312008: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alcohol Use Disorder
Keywords: Alcohol use disorder
Oxytocin, intranasal
Alcohol tolerance
Alcohol intake
Alcohol treatment
Alcohol, intravenous
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2 Arms; both 2 session crossover design
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Subjective Effect of Alcohol - Craving
timeFrame: 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo, scheduled 3-4 weeks apart, order counter-balanced.
measure: Subjective Effects of Alcohol - Intoxication
timeFrame: 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo, scheduled 3-4 weeks apart, order counter-balanced.
measure: Stop Signal Response Task
timeFrame: 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo, scheduled 3-4 weeks apart, order counter-balanced.
measure: Stroop Test
timeFrame: 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo, scheduled 3-4 weeks apart, order counter-balanced.
measure: Alcohol Purchase Task (Variable OMax)
timeFrame: 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: University Hospital
state: Indiana
Study officials:
affiliation: Psychiatry, Indiana University School of Medicine
name: Martin H Plawecki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: