Status:
TERMINATED
Does Oxytocin Alter Tolerance to or Motivation for Alcohol
Lead Sponsor:
Indiana University
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
21-60 years
Phase:
PHASE2
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 s...
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 ...
Eligibility Criteria
Inclusion
- Heavy alcohol drinkers.
- Able to understand/complete questionnaires and procedures in English.
- Have venous access sufficient to allow blood sampling.
Exclusion
- 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.
Key Trial Info
Start Date :
January 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05312008
Start Date
January 16 2022
End Date
December 21 2023
Last Update
March 4 2025
Active Locations (1)
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1
University Hospital
Indianapolis, Indiana, United States, 46202