Laboratory Studies on Oxytocin for Treatment of Alcohol Use Disorder

Completed · Phase 1 · Has a placebo group

Conditions studied: Alcoholism, Alcohol Related Disorders

In brief

This study will examine the utility of the neuropeptide oxytocin (OT) as a potential new medication for the treatment of Alcohol use disorder (AUD). Non-treatment seeking men and women with AUD will be enrolled in a double blind placebo controlled phase I clinical trial. Participants will complete an 7-day inpatient protocol. During the first 3 days of the inpatient protocol, participants will complete alcohol abstinence in which withdrawal symptoms are measured,and urine will be collected to determine withdrawal symptom severity and urine levels of the stress hormone cortisol. Participants will then complete 3 laboratory procedures which measure 1) stress response, 2) motivation to drink alcohol and 3) subjective and physiological effects of alcohol. Finally, because participants are individuals with AUD, investigators will administer a brief intervention to address their risky alcohol drinking and problems before discharge.

Key facts

Study ID

NCT02407340

Run by

Johns Hopkins University

People needed

27

Starts

2015-03-01

Expected to finish

2017-06-15

Last updated by the study team

2017-12-04

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Healthy 21-50 years old male and female subjects
• Must meet Diagnostic and Statistical Manual (DSM) -V criteria for AUD and not be seeking treatment
• Actively drinking
• Positive blood phosphatidylethanol (PEth) blood test

You may not qualify if…

• Current DSM-V major current mood or anxiety disorder or drug use disorder (excluding alcohol and nicotine use disorders, and moderate-severe cannabis use disorder); in or in need of treatment
• Drug use in last 30 days and/or positive urine toxicology screens (excluding marijuana)
• History of seizure disorder or closed head trauma
• History of withdrawal-related seizures or serious alcohol withdrawal symptoms
• HIV positive
• Neuroendocrine disorder
• Any serious medical condition that would place subject at risk or interfere with study participation
• Liver function tests more than 3 times normal at screening
• Prescription medications in last 3 months that could affect central nervous system or HPA axis function
• Women who are pregnant, nursing or planning pregnancy cannot participate

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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