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Laboratory Studies on Oxytocin for Treatment of Alcohol Use Disorder

Primary Purpose

Alcoholism, Alcohol Related Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
oxytocin
placebo
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcoholism focused on measuring Alcohol Withdrawal Delirium

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oxytocin

Placebo

Arm Description

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

Intranasal placebo administered 3 times daily for 1 week

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

alcohol effects
Group mean stimulation and sedation subscale scores on the biphasic alcohol effects scale (BAES), a 14-item scale consisting of adjectives that describe the stimulant- and sedative-like effects of alcohol. The items are presented in alphabetical order, and are rated on an 11-point rating scale from 0=Not at All to 10=Extremely after controlled alcohol administration.
side effects
side effects reported on the Systematic Assessment for Treatment Emergent Events (SAFTEE)
Salivary cortisol
Peak and Area under the curve salivary cortisol levels after trier social stress test

Full Information

First Posted
March 30, 2015
Last Updated
November 30, 2017
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT02407340
Brief Title
Laboratory Studies on Oxytocin for Treatment of Alcohol Use Disorder
Official Title
Laboratory Studies on Oxytocin for Treatment of Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
June 15, 2017 (Actual)
Study Completion Date
June 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study will lay the necessary groundwork for future comprehensive research to examine the utility of the neuropeptide oxytocin (OT) as a potential new medication for the treatment of Alcohol use disorder (AUD). OT modulates a number of key systems involved in addiction processes, including dopamine (DA) mesolimbic reward circuitry, and hypothalamic-pituitary-adrenal (HPA) axis and corticotrophin-releasing factor (CRF) stress systems, and has low abuse liability. Our overarching hypothesis is that OT will attenuate several measures thought to drive compulsive alcohol drinking and relapse. Specifically, investigators will examine whether OT decreases acute stress responses, alleviates alcohol withdrawal symptoms, reduces craving and motivation to drink, and decreases alcohol self-administration. Since interactions with alcohol are an important focus of our study, investigators will enroll non-treatment seeking heavy drinkers with AUD in a double blind, placebo controlled inpatient protocol. Subjects will be randomized to receive intranasal OT (40 IU/dose) or placebo 3 times daily. Participants will complete alcohol detoxification; investigators will measure alcohol withdrawal symptoms, craving, and 24-hr urinary free CORT. Participants will then complete 3 laboratory procedures in fixed order. The Trier Social Stress Test (TSST) which includes public speaking and performance of mental arithmetic will be used to examine subjective and physiological stress responses. An alcohol motivated responding (AMR) procedure will be used to examine subjects' responding to earn either drinks or money. A cumulative alcohol-dosing (CAD) procedure will be used to examine physiological and subjective responses across several blood alcohol levels. cortisol (CORT) levels will also be assessed. This study will provide new information on OT efficacy across a range of different measures predictive of alcohol use and misuse, and, if OT shows efficacy, help clarify the mechanism of OT action.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Alcohol Related Disorders
Keywords
Alcohol Withdrawal Delirium

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Oxytocin vs. placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind, placebo controlled
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin
Arm Type
Active Comparator
Arm Description
intranasal oxytocin - 40 International Units (IU) dose administered 3 times daily for 1 week
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intranasal placebo administered 3 times daily for 1 week
Intervention Type
Drug
Intervention Name(s)
oxytocin
Other Intervention Name(s)
syntocinon
Intervention Description
40 international Units (IU) 3xday delivered as 5 sprays (0.1 mL) per nostril
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
(Na Cl 0.65%, Phenylcarbinol, Benzalkonium Cl)
Intervention Description
5 sprays (0.1 mL) per nostril 3xday; bottles are identical to those of active drug
Primary Outcome Measure Information:
Title
Alcohol drinking
Description
Group mean number of Standard Drink Units earned and self-administered in the laboratory session
Time Frame
1 day
Secondary Outcome Measure Information:
Title
alcohol effects
Description
Group mean stimulation and sedation subscale scores on the biphasic alcohol effects scale (BAES), a 14-item scale consisting of adjectives that describe the stimulant- and sedative-like effects of alcohol. The items are presented in alphabetical order, and are rated on an 11-point rating scale from 0=Not at All to 10=Extremely after controlled alcohol administration.
Time Frame
1 day
Title
side effects
Description
side effects reported on the Systematic Assessment for Treatment Emergent Events (SAFTEE)
Time Frame
1 week
Title
Salivary cortisol
Description
Peak and Area under the curve salivary cortisol levels after trier social stress test
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elise Weerts, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

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Laboratory Studies on Oxytocin for Treatment of Alcohol Use Disorder

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