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Intranasal Oxytocin for the Treatment of Alcohol Use Disorder

Primary Purpose

Alcohol Use Disorder, Alcohol Misuse

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Instranasal Oxytocin
Sponsored by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Be at least 21 years of age.
  2. Have a current (past 12 months) DSM-5 diagnosis of AUD (4 or more symptoms) assessed using the MINI neuropsychiatric interview version 7.0.2 (at least moderate severity, ICD-10-CM Code F10.20 alcohol dependence, uncomplicated).
  3. Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent document (either just prior to or immediately after signing consent).
  4. Be seeking treatment for problems with alcohol reduction in drinking.
  5. Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
  6. Agree (if the subject is female and of child bearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal:

    1. oral contraceptives,
    2. contraceptive sponge,
    3. patch,
    4. double barrier (diaphragm/spermicidal or condom/spermicidal),
    5. intrauterine contraceptive system,
    6. etonogestrel implant,
    7. medroxyprogesterone acetate contraceptive injection,
    8. complete abstinence from sexual intercourse, and/or
    9. hormonal vaginal contraceptive ring.
  7. Be able to take intranasal investigational products and be willing to adhere to the investigational product regimen.
  8. Complete all assessments required at screening and baseline.
  9. Have a place to live in the 2 weeks prior to randomization and not be at risk that s/he will lose his/her housing by Study Week 14.
  10. Not anticipate any significant problems with transportation arrangements or available time to travel to the study site by Study Week 14.
  11. Not have any plans to move within Study Week 14 to a location which would make continued participation in the study impractical.
  12. Not have any unresolved legal problems that could jeopardize continuation or completion of the study.
  13. Provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment.
  14. Be someone who in the opinion of the investigator would be expected to complete the study protocol.
  15. Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may substantially interfere with study participation.
  16. If taking a medication for depression or anxiety, must have been taking a stable dose in the 2-months prior to randomization and plan to continue during the study. This includes drugs such as the following:

    • SSRIs
    • Dual uptake inhibitors
    • SNRIs
    • Tricyclic antidepressants
    • MAOIs
    • Bupropion
  17. Not currently taking oxytocin and agree not to take non-study oxytocin for the duration of the study.

Exclusion Criteria:

Contact study site for exclusion criteria.

Sites / Locations

  • University of CaliforniaRecruiting
  • Johns Hopkins School of MedicineRecruiting
  • Boston Medical CenterRecruiting
  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intranasal Oxytocin

Instrasal Placebo

Arm Description

Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL.

Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL.

Outcomes

Primary Outcome Measures

Weekly Percentage of Heavy Drinking Days
The primary efficacy endpoint is the weekly percentage of heavy drinking days during the 10-week maintenance treatment period. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men. Drinking data will be collected by the Timeline Followback (TLFB) method.

Secondary Outcome Measures

Percentage of subjects with no heavy drinking days during treatment
Percentage of subjects abstinent from alcohol during treatment
Percentage of subjects with at least a 1-level World Health Organization WHO) drinking risk category decrease
Percentage of subjects with at least a 2-level World Health Organization WHO) drinking risk category decrease
Percentage of days abstinent from alcohol per week
Weekly mean number of drinks per week
Weekly mean drinks per drinking day
MINI AUD Score at end of study
Cigarettes smoked per week among smokers
Abstinence from cigarette smoking among smokers
Other nicotine product use per week among other nicotine product users
Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) scores (attachment-related anxiety)
PROMIS sleep disturbances scores
PROMIS alcohol-related negative consequences scores
PROMIS pain interference scores
Profile of Moods States (POMS) scores (including subscale scores)
Urge to Drink Scores

Full Information

First Posted
March 14, 2019
Last Updated
June 6, 2023
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03878316
Brief Title
Intranasal Oxytocin for the Treatment of Alcohol Use Disorder
Official Title
Randomized, Double Blind, Placebo-Controlled Trial of the Efficacy of Intranasal Oxytocin for the Treatment of Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary: The primary objective of the study is to compare the efficacy of intranasal oxytocin in reducing the weekly percentage of heavy drinking days over the 10 weeks of maintenance treatment among subjects with moderate to severe Alcohol Use Disorder (AUD). A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men. Secondary: Secondary objectives include assessment of other measures of the effects of oxytocin compared with placebo on reduction of alcohol use as well as effects on psychological assessments, alcohol craving, alcohol-related consequences, cigarette smoking and other nicotine use, retention in the study, safety, and application site (nares) tolerability throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Alcohol Misuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intranasal Oxytocin
Arm Type
Active Comparator
Arm Description
Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL.
Arm Title
Instrasal Placebo
Arm Type
Placebo Comparator
Arm Description
Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL.
Intervention Type
Drug
Intervention Name(s)
Instranasal Oxytocin
Intervention Description
Intranasal Oxytocin - concentrated formulation - 35 IU per dose
Primary Outcome Measure Information:
Title
Weekly Percentage of Heavy Drinking Days
Description
The primary efficacy endpoint is the weekly percentage of heavy drinking days during the 10-week maintenance treatment period. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men. Drinking data will be collected by the Timeline Followback (TLFB) method.
Time Frame
10 Weeks
Secondary Outcome Measure Information:
Title
Percentage of subjects with no heavy drinking days during treatment
Time Frame
10 Weeks
Title
Percentage of subjects abstinent from alcohol during treatment
Time Frame
10 weeks
Title
Percentage of subjects with at least a 1-level World Health Organization WHO) drinking risk category decrease
Time Frame
10 weeks
Title
Percentage of subjects with at least a 2-level World Health Organization WHO) drinking risk category decrease
Time Frame
10 weeks
Title
Percentage of days abstinent from alcohol per week
Time Frame
10 weeks
Title
Weekly mean number of drinks per week
Time Frame
12 weeks
Title
Weekly mean drinks per drinking day
Time Frame
10 weeks
Title
MINI AUD Score at end of study
Time Frame
12 weeks
Title
Cigarettes smoked per week among smokers
Time Frame
10 weeks
Title
Abstinence from cigarette smoking among smokers
Time Frame
12 weeks
Title
Other nicotine product use per week among other nicotine product users
Time Frame
10 weeks
Title
Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) scores (attachment-related anxiety)
Time Frame
12 weeks
Title
PROMIS sleep disturbances scores
Time Frame
10 weeks
Title
PROMIS alcohol-related negative consequences scores
Time Frame
10 weeks
Title
PROMIS pain interference scores
Time Frame
10 weeks
Title
Profile of Moods States (POMS) scores (including subscale scores)
Time Frame
10 weeks
Title
Urge to Drink Scores
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be at least 21 years of age. Have a current (past 12 months) DSM-5 diagnosis of AUD (4 or more symptoms) assessed using the MINI neuropsychiatric interview version 7.0.2 (at least moderate severity, ICD-10-CM Code F10.20 alcohol dependence, uncomplicated). Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent document (either just prior to or immediately after signing consent). Be seeking treatment for problems with alcohol reduction in drinking. Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol. Agree (if the subject is female and of child bearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal: oral contraceptives, contraceptive sponge, patch, double barrier (diaphragm/spermicidal or condom/spermicidal), intrauterine contraceptive system, etonogestrel implant, medroxyprogesterone acetate contraceptive injection, complete abstinence from sexual intercourse, and/or hormonal vaginal contraceptive ring. Be able to take intranasal investigational products and be willing to adhere to the investigational product regimen. Complete all assessments required at screening and baseline. Have a place to live in the 2 weeks prior to randomization and not be at risk that s/he will lose his/her housing by Study Week 14. Not anticipate any significant problems with transportation arrangements or available time to travel to the study site by Study Week 14. Not have any plans to move within Study Week 14 to a location which would make continued participation in the study impractical. Not have any unresolved legal problems that could jeopardize continuation or completion of the study. Provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment. Be someone who in the opinion of the investigator would be expected to complete the study protocol. Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may substantially interfere with study participation. If taking a medication for depression or anxiety, must have been taking a stable dose in the 2-months prior to randomization and plan to continue during the study. This includes drugs such as the following: SSRIs Dual uptake inhibitors SNRIs Tricyclic antidepressants MAOIs Bupropion Not currently taking oxytocin and agree not to take non-study oxytocin for the duration of the study. Exclusion Criteria: Contact study site for exclusion criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Ryan, MBA
Phone
3014434225
Email
mryan1@nih.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raye Litten, PHD
Organizational Affiliation
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Jenkins, MS
Phone
310-206-6756
Email
jenkinsj@ucla.edu
First Name & Middle Initial & Last Name & Degree
Lara Ray, PhD
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey Perry
Phone
410-550-1683
Email
sperry@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Eric Strain, MD
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alyssa Pingitore
Phone
617-414-1914
Email
alyssa.pingitore@bmc.org
First Name & Middle Initial & Last Name & Degree
Eric Devine, PhD
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Jenkins-Mendoza
Phone
434-243-0562
Email
emj9c@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Nassima Ait-Daoud Tiouririne, MD

12. IPD Sharing Statement

Learn more about this trial

Intranasal Oxytocin for the Treatment of Alcohol Use Disorder

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