Intranasal Oxytocin for the Treatment of Alcohol Use Disorder

NCT ID: NCT03878316

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-29
• Study Completion Date: 2023-10-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intranasal Oxytocin

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.

Group Type: ACTIVE_COMPARATOR

Instranasal Oxytocin

Intervention Type: DRUG

Intranasal Oxytocin - concentrated formulation - 35 IU per dose

Instrasal Placebo

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.

Group Type: PLACEBO_COMPARATOR

Instranasal Oxytocin

Intervention Type: DRUG

Intranasal Oxytocin - concentrated formulation - 35 IU per dose

Interventions

Instranasal Oxytocin

Intranasal Oxytocin - concentrated formulation - 35 IU per dose

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raye Litten, PHD

Role: PRINCIPAL_INVESTIGATOR

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Locations

University of California

Los Angeles, California, United States

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCIG 007

Identifier Type: -

Identifier Source: org_study_id