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Laboratory Studies on Oxytocin for Treatment of Alcohol Use Disorder

NCT02407340 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2017-12-04

No results posted yet for this study

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.

Conditions

  • Alcoholism
  • Alcohol Related Disorders

Interventions

DRUG

oxytocin

40 international Units (IU) 3xday delivered as 5 sprays (0.1 mL) per nostril

DRUG

placebo

5 sprays (0.1 mL) per nostril 3xday; bottles are identical to those of active drug

Sponsors & Collaborators

Principal Investigators

  • Elise Weerts, Ph.D. · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-06-15
Completion
2017-06-15

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02407340 on ClinicalTrials.gov