NCT02407340

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed
Last Updated

December 4, 2017

Status Verified

November 1, 2017

Enrollment Period

2.3 years

First QC Date

March 30, 2015

Last Update Submit

November 30, 2017

Conditions

AlcoholismAlcohol Related Disorders

Keywords

Alcohol Withdrawal Delirium

Outcome Measures

Primary Outcomes (1)

  • Alcohol drinking

    Group mean number of Standard Drink Units earned and self-administered in the laboratory session

    1 day

Secondary Outcomes (3)

  • alcohol effects

    1 day

  • side effects

    1 week

  • Salivary cortisol

    1 day

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR

intranasal oxytocin - 40 International Units (IU) dose administered 3 times daily for 1 week

Drug: oxytocin

Placebo

PLACEBO COMPARATOR

Intranasal placebo administered 3 times daily for 1 week

Drug: placebo

Interventions

oxytocinDRUG

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

Also known as: syntocinon
Oxytocin
placeboDRUG

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

Also known as: (Na Cl 0.65%, Phenylcarbinol, Benzalkonium Cl)
Placebo

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

AlcoholismAlcohol-Related DisordersAlcohol Withdrawal Delirium

Interventions

OxytocinBenzyl Alcohols

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersAlcohol-Induced Disorders, Nervous SystemNeurotoxicity SyndromesNervous System DiseasesPoisoningAlcohol-Induced DisordersSubstance Withdrawal Syndrome

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsAlcoholsOrganic ChemicalsBenzyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Elise Weerts, Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind, placebo controlled
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Oxytocin vs. placebo
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 2, 2015

Study Start

March 1, 2015

Primary Completion

June 15, 2017

Study Completion

June 15, 2017

Last Updated

December 4, 2017

Record last verified: 2017-11

Locations

US(1)