CompletedPhase 1

Laboratory Studies on Oxytocin for Treatment of Alcohol Use Disorder

United States27 participantsStarted 2015-03

Plain-language summary

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.

Who can participate

Age range21 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Alcohol drinking

Timeframe: 1 day

Trial details

NCT IDNCT02407340

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06-15