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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Intranasal Oxytocin for the Treatment of Alcohol Use Disorder

NCTNCT03878316 (opens ClinicalTrials.gov in a new tab)Other idNCIG 007
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
100 participants (actual)
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Nih
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
29 Jun 2022
Primary completion
13 Oct 2023
Completion
13 Oct 2023
First posted
18 Mar 2019
Last update posted
7 Aug 2025
Conditions
Alcohol Use Disorder · Alcohol Misuse

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202220232024
  1. Ph 2

    Intranasal Oxytocin for the Treatment of Alcohol Use Disorder

    NCT03878316

    29 Jun 2022 to 13 Oct 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Instranasal OxytocinDrug

Arms2

  • Active comparator

    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.

  • Placebo comparator

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Weekly Percentage of Heavy Drinking Days

    Time frame · Weeks 3-12

    Registry 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.

Secondary outcomes(17)

  1. Percentage of Subjects With no Heavy Drinking Days

    Time frame · weeks 3-12

    Registry description

    Percentage of subjects with no heavy drinking days during the 10-week Maintenance period

  2. Percentage of Subjects Abstinent From Alcohol

    Time frame · Weeks 3-12

    Registry description

    Percentage of subjects abstinent from alcohol during the 10-week Maintenance period

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

    Time frame · weeks 3-12

    Registry description

    Percentage of subjects with at least a 1-level World Health Organization (WHO) drinking risk category decrease from the baseline level to (the period including the 28 days before screening) to the level during the treatment phase (Study Weeks 3-12). The WHO levels of average alcohol consumption per day vary by Sex of participants and are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate "Abstinent" category.

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

    Time frame · weeks 3-12

    Registry description

    Percentage of subjects with at least a 2-level World Health Organization (WHO) drinking risk category decrease from the baseline level to (the period including the 28 days before screening) to the level during the treatment phase (Study Weeks 3-12). The WHO levels of average alcohol consumption per day vary by Sex of participants and are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate "Abstinent" category.

  5. Percentage of Days Abstinent Per Week

    Time frame · weeks 3-12

    Registry description

    Timeline Follow Back daily drinking data used to calculate the % of days abstinent per week during the 10-week Maintenance period.

  6. Weekly Mean Number of Drinks Per Week

    Time frame · weeks 3-12

    Registry description

    Weekly mean number of drinks per week during the 10-week Maintenance period.

  7. Weekly Mean Drinks Per Drinking Day

    Time frame · weeks 3-12

    Registry description

    Weekly mean drinks per drinking day during the 10-week Maintenance period.

  8. Number of Alcohol Use Disorder Symptoms (MINI)

    Time frame · week 13

    Registry description

    The MINI (paper version 7.0.2) is a short structured diagnostic interview, developed jointly by psychiatrists and clinicians in the United States and Europe, for DSM-5 and ICD-10 psychiatric disorders (Sheehan-1998). This scale is a count of the number of alcohol use disorder symptoms. Minimum = 0 and maximum=11. Higher scores indicate worse outcome.

  9. Cigarettes Smoked Per Week Among Smokers

    Time frame · weeks 3-12

    Registry description

    Cigarettes smoked per week among smokers during the 10-week Maintenance period.

  10. Abstinence From Cigarette Smoking Among Smokers

    Time frame · weeks 3-12

    Registry description

    Abstinence from cigarette smoking among smokers during the 10-week Maintenance period.

  11. Other Nicotine Product Use - Days Per Week Among Other Nicotine Product Users

    Time frame · weeks 3-12

    Registry description

    Other nicotine product use - days per week among other nicotine product users during the Maintenance period

  12. Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) Scores (Attachment-related Anxiety Subscale)

    Time frame · weeks 3-12

    Registry description

    Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) scores (attachment-related anxiety subscale) during the 10-week Maintenance period. Minimum = 0 and maximum = 126. Higher scores are worse outcome.

  13. PROMIS Sleep Disturbances Score

    Time frame · weeks 3-12

    Registry description

    PROMIS® (Patient-Reported Outcomes Measurement Information System) Sleep Disturbances score (Short Form 8b) during the 10-week Maintenance period. Scores are T-scores with a mean of 50 and standard deviation of 10. Minimum = 0 and maximum = 100. Higher scores are worse outcome (i.e., more sleep disturbance).

  14. PROMIS Alcohol-related Negative Consequences Score

    Time frame · weeks 3-12

    Registry description

    PROMIS® (Patient-Reported Outcomes Measurement Information System) alcohol-related negative consequences score (Long Form) during the 10-week Maintenance period. Scores are T-scores with a mean of 50 and standard deviation of 10. Minimum = 0 and maximum = 100. Higher scores are worse outcome (i.e., more alcohol-related negative consequences).

  15. PROMIS Pain Interference Score

    Time frame · weeks 3-12

    Registry description

    PROMIS® (Patient-Reported Outcomes Measurement Information System) Pain Interference score (Short Form 8a) during the 10-week Maintenance period. Scores are T-scores with a mean of 50 and standard deviation of 10. Minimum = 0 and maximum = 100. Higher scores are worse outcome (i.e., more pain interference).

  16. Profile of Moods States (POMS) - Total Mood Disturbance

    Time frame · weeks 3-12

    Registry description

    Profile of Moods States (POMS) - Total Mood Disturbance during the 10-week Maintenance period. Minimum = -32 and maximum = 200. Higher scores are worse outcome.

  17. Urge to Drink Alcohol Craving Score

    Time frame · weeks 3-12

    Registry description

    Urge to Drink alcohol craving score during the 10-week Maintenance period. Minimum = 0 and maximum = 35. Higher scores are worse outcome.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Weeks 3-12

Weekly Percentage of Heavy Drinking Days

GroupValue (percentage of days per week)Spread
Intranasal Oxytocin51.53.9
Instrasal Placebo52.93.9
Secondary and other outcome results(7)
Secondary outcomeNumber· weeks 3-12

Percentage of Subjects With no Heavy Drinking Days

GroupValue (percentage of participants)
Intranasal Oxytocin2.1
Instrasal Placebo6.3
Secondary outcomeNumber· Weeks 3-12

Percentage of Subjects Abstinent From Alcohol

GroupValue (percentage of participants)
Intranasal Oxytocin0
Instrasal Placebo2.1
Secondary outcomeNumber· weeks 3-12

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

GroupValue (percentage of participants)
Intranasal Oxytocin59.6
Instrasal Placebo53.2
Secondary outcomeNumber· weeks 3-12

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

GroupValue (percentage of participants)
Intranasal Oxytocin23.4
Instrasal Placebo23.4
Secondary outcomeLeast squares mean· weeks 3-12

Percentage of Days Abstinent Per Week

GroupValue (percentage of days per week)Spread
Intranasal Oxytocin23.22.5
Instrasal Placebo22.62.5
Secondary outcomeLeast squares mean· weeks 3-12

Weekly Mean Number of Drinks Per Week

GroupValue (standard drinking units (SDUs) per week)Spread
Intranasal Oxytocin33.12.2
Instrasal Placebo34.72.3
Secondary outcomeLeast squares mean· weeks 3-12

Weekly Mean Drinks Per Drinking Day

GroupValue (standard drinking units (SDUs) per week)Spread
Intranasal Oxytocin6.20.3
Instrasal Placebo6.30.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Intranasal OxytocinOxytocin, 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. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose0 / 490 / 4944 / 49
Instrasal PlaceboIdentically 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. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose0 / 480 / 4845 / 48

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

14 results

Intranasal Oxytocin for Alcohol Use Disorder: A Randomized, Double-Blind, Placebo-Controlled Multisite Trial Assessing Efficacy and Safety.

Tiouririne et al. 2026Alcohol, clinical & experimental research

PMID 42458234PMC13373018DOI 10.1111/acer.70326PUB-42458234

CC BY14 results
Download PDFSee results (14)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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