Intranasal Oxytocin for the Treatment of Alcohol Use Disorder

NCT03878316 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: NCIG 007
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Alcohol Use Disorder; Alcohol Misuse

Outcome Measures

Primary Outcomes (1)

• 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.

  Weeks 3-12

Secondary Outcomes (17)

• Percentage of Subjects With no Heavy Drinking Days

  weeks 3-12

• Percentage of Subjects Abstinent From Alcohol

  Weeks 3-12

• Percentage of Subjects With at Least a 1-level World Health Organization (WHO) Drinking Risk Category Decrease

  weeks 3-12

• Percentage of Subjects With at Least a 2-level World Health Organization (WHO) Drinking Risk Category Decrease

  weeks 3-12

• Percentage of Days Abstinent Per Week

  weeks 3-12

Study Arms (2)

Intranasal Oxytocin

ACTIVE COMPARATOR

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.

Drug: Instranasal Oxytocin

Instrasal Placebo

PLACEBO COMPARATOR

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.

Drug: Instranasal Oxytocin

Interventions

Instranasal Oxytocin DRUG

Intranasal Oxytocin - concentrated formulation - 35 IU per dose

Instrasal Placebo; Intranasal Oxytocin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (4)

University of California

Los Angeles, California, 90095, United States

Location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21224, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Daniel Falk
• Organization: National Institute on Alcohol Abuse and Alcoholism

falkde@mail.nih.gov

301-443-0788

Study Officials

• Raye Litten, PHD

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: June 29, 2022
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: August 7, 2025
• Results First Posted: July 23, 2025

Record last verified: 2025-07

Locations

US (4)