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Study · Randomized controlled trial · n = 100 · 2026

14 results

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

Tiouririne NA, Legan JA, Devine E, Lee K, Weerts EM, Ellis JD, Ray L, Shoptaw S, Falk D, Ryan M, Litten R, Seneviratne C, Ransom J, Scott C

Alcohol, clinical & experimental research1 Jul 2026

PMID42458234 (opens in a new tab)PMCIDPMC13373018 (opens in a new tab)DOI10.1111/acer.70326 (opens in a new tab)PepBankPUB-42458234
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Summary

BackgroundThe neuropeptide oxytocin offers a potentially effective treatment for alcohol use disorder (AUD). Acting centrally in the brain, oxytocin mediates a range of behavioral effects, including reward, stress response, social affiliation, learning, memory, and addictive behaviors. Animal studies demonstrate oxytocin's ability to reduce alcohol consumption, but results in human trials have been mixed. Some studies report reductions in withdrawal symptoms, heavy drinking, and craving, whereas others show no effects. The purpose of this 12-week clinical trial was to evaluate the efficacy and safety of intranasal oxytocin in individuals with AUD.MethodsOxytocin (up to 70 International Units [IU]/day) or placebo was administered to 100 individuals diagnosed with AUD in a double-blind, randomized, 12-week multisite trial. The primary outcome was the weekly percentage of heavy drinking days (PHDD) over 10 weeks of maintenance treatment. Secondary outcomes included additional drinking measures, urge to drink, psychological assessments, alcohol-related consequences, nicotine use, and safety and tolerability of intranasal oxytocin.ResultsNo significant differences were observed in PHDD between groups during the 10-week maintenance phase. However, a small, numerically greater reduction in drinking was seen in the oxytocin group compared with placebo from weeks 9 to 12. Similar patterns were found across secondary drinking outcomes. No significant differences were observed in AUD symptoms, alcohol-related consequences, craving, mood, sleep, pain, or substance use. At the end of treatment, participants receiving oxytocin scored significantly lower on measures of anger and physical aggression. Oxytocin was well tolerated; adverse events were mild and comparable across groups. The most common event in both groups was hyposmia.ConclusionIntranasal oxytocin was well tolerated but did not significantly reduce drinking or AUD-related outcomes. Higher doses, longer treatment duration, or larger trials may be required to identify responsive subgroups and determine oxytocin's efficacy in AUD.Trial registrationClinicalTrials.gov, Identifier: NCT03878316. Registered March 14, 2019 (https://clinicaltrials.gov/ct2/show/NCT03878316).
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study14

14 results from studies that gave the peptide. 14 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with alcohol use disorder, intranasal oxytocin did not significantly change the percentage of heavy drinking days compared with placebo.

    In plain wordsIn adults with alcohol use disorder, oxytocin did not change the share of heavy drinking days compared with placebo.

    Peptide
    Oxytocin
    Outcome
    No significant changeWeekly percentage of heavy drinking days over 10 weeks
    Study

    n = 100

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Addiction, withdrawal and alcohol intake · Mental health and mood
    Studied dose
    up to 70 IU/day · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    No significant differences were observed in PHDD between groups during the 10-week maintenance phase.
    2 context sentences
    Summary · context
    The primary outcome was the weekly percentage of heavy drinking days (PHDD) over 10 weeks of maintenance treatment.
    Summary · context
    Oxytocin (up to 70 International Units [IU]/day) or placebo was administered to 100 individuals diagnosed with AUD in a double-blind, randomized, 12-week multisite trial.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with alcohol use disorder, the abstract reports patterns across secondary drinking outcomes that were similar to those of the main drinking result; it does not name the outcomes or state significance.

    In plain wordsIn adults with alcohol use disorder, other drinking measures showed patterns like the main one with oxytocin compared with placebo; no details were given.

    Peptide
    Oxytocin
    Outcome
    Direction not reportedSecondary drinking outcomes
    Study

    n = 100

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Addiction, withdrawal and alcohol intake · Mental health and mood
    Studied dose
    up to 70 IU/day · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Similar patterns were found across secondary drinking outcomes.
    1 context sentence
    Summary · context
    Oxytocin (up to 70 International Units [IU]/day) or placebo was administered to 100 individuals diagnosed with AUD in a double-blind, randomized, 12-week multisite trial.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with alcohol use disorder, intranasal oxytocin did not significantly change AUD symptoms compared with placebo.

    In plain wordsIn adults with alcohol use disorder, oxytocin did not change disorder symptoms compared with placebo.

    Peptide
    Oxytocin
    Outcome
    No significant changeAlcohol use disorder symptoms
    Study

    n = 100

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Addiction, withdrawal and alcohol intake · Mental health and mood
    Studied dose
    up to 70 IU/day · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    No significant differences were observed in AUD symptoms, alcohol-related consequences, craving, mood, sleep, pain, or substance use.
    1 context sentence
    Summary · context
    Oxytocin (up to 70 International Units [IU]/day) or placebo was administered to 100 individuals diagnosed with AUD in a double-blind, randomized, 12-week multisite trial.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adults with alcohol use disorder, intranasal oxytocin did not significantly change alcohol-related consequences compared with placebo.

    In plain wordsIn adults with alcohol use disorder, oxytocin did not change alcohol-related problems compared with placebo.

    Peptide
    Oxytocin
    Outcome
    No significant changeAlcohol-related consequences
    Study

    n = 100

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Addiction, withdrawal and alcohol intake · Mental health and mood
    Studied dose
    up to 70 IU/day · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    No significant differences were observed in AUD symptoms, alcohol-related consequences, craving, mood, sleep, pain, or substance use.
    1 context sentence
    Summary · context
    Oxytocin (up to 70 International Units [IU]/day) or placebo was administered to 100 individuals diagnosed with AUD in a double-blind, randomized, 12-week multisite trial.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In adults with alcohol use disorder, intranasal oxytocin did not significantly change craving compared with placebo.

    In plain wordsIn adults with alcohol use disorder, oxytocin did not change craving compared with placebo.

    Peptide
    Oxytocin
    Outcome
    No significant changeCraving
    Study

    n = 100

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Addiction, withdrawal and alcohol intake · Mental health and mood
    Studied dose
    up to 70 IU/day · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    No significant differences were observed in AUD symptoms, alcohol-related consequences, craving, mood, sleep, pain, or substance use.
    1 context sentence
    Summary · context
    Oxytocin (up to 70 International Units [IU]/day) or placebo was administered to 100 individuals diagnosed with AUD in a double-blind, randomized, 12-week multisite trial.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In adults with alcohol use disorder, intranasal oxytocin did not significantly change mood compared with placebo.

    In plain wordsIn adults with alcohol use disorder, oxytocin did not change mood compared with placebo.

    Peptide
    Oxytocin
    Outcome
    No significant changeMood
    Study

    n = 100

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Anxiety and mood · Mental health and mood
    Studied dose
    up to 70 IU/day · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    No significant differences were observed in AUD symptoms, alcohol-related consequences, craving, mood, sleep, pain, or substance use.
    1 context sentence
    Summary · context
    Oxytocin (up to 70 International Units [IU]/day) or placebo was administered to 100 individuals diagnosed with AUD in a double-blind, randomized, 12-week multisite trial.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In adults with alcohol use disorder, intranasal oxytocin did not significantly change sleep compared with placebo.

    In plain wordsIn adults with alcohol use disorder, oxytocin did not change sleep compared with placebo.

    Peptide
    Oxytocin
    Outcome
    No significant changeSleep
    Study

    n = 100

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Sleep · Sleep
    Studied dose
    up to 70 IU/day · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    No significant differences were observed in AUD symptoms, alcohol-related consequences, craving, mood, sleep, pain, or substance use.
    1 context sentence
    Summary · context
    Oxytocin (up to 70 International Units [IU]/day) or placebo was administered to 100 individuals diagnosed with AUD in a double-blind, randomized, 12-week multisite trial.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In adults with alcohol use disorder, intranasal oxytocin did not significantly change pain compared with placebo.

    In plain wordsIn adults with alcohol use disorder, oxytocin did not change pain compared with placebo.

    Peptide
    Oxytocin
    Outcome
    No significant changePain
    Study

    n = 100

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Pain · Nervous system and cognition
    Studied dose
    up to 70 IU/day · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    No significant differences were observed in AUD symptoms, alcohol-related consequences, craving, mood, sleep, pain, or substance use.
    1 context sentence
    Summary · context
    Oxytocin (up to 70 International Units [IU]/day) or placebo was administered to 100 individuals diagnosed with AUD in a double-blind, randomized, 12-week multisite trial.
  9. 09HumanRandomized controlled trialEfficacy outcome

    In adults with alcohol use disorder, intranasal oxytocin did not significantly change other substance use compared with placebo.

    In plain wordsIn adults with alcohol use disorder, oxytocin did not change other substance use compared with placebo.

    Peptide
    Oxytocin
    Outcome
    No significant changeSubstance use
    Study

    n = 100

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Addiction, withdrawal and alcohol intake · Mental health and mood
    Studied dose
    up to 70 IU/day · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    No significant differences were observed in AUD symptoms, alcohol-related consequences, craving, mood, sleep, pain, or substance use.
    1 context sentence
    Summary · context
    Oxytocin (up to 70 International Units [IU]/day) or placebo was administered to 100 individuals diagnosed with AUD in a double-blind, randomized, 12-week multisite trial.
  10. 10HumanRandomized controlled trialSafety outcome

    In adults with alcohol use disorder, intranasal oxytocin was well tolerated and adverse events were mild and comparable across groups.

    In plain wordsIn adults with alcohol use disorder, oxytocin was well tolerated, and side effects were mild and similar to placebo.

    Peptide
    Oxytocin
    Outcome
    No significant changeAdverse events overall
    Study

    n = 100

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Adverse events · Whole body
    Studied dose
    up to 70 IU/day · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Oxytocin was well tolerated; adverse events were mild and comparable across groups.
    1 context sentence
    Summary · context
    Oxytocin (up to 70 International Units [IU]/day) or placebo was administered to 100 individuals diagnosed with AUD in a double-blind, randomized, 12-week multisite trial.
  11. 11HumanRandomized controlled trialEfficacy outcome

    In adults with alcohol use disorder, drinking fell slightly more in the oxytocin group than with placebo from weeks 9 to 12, a numerical difference.

    In plain wordsIn adults with alcohol use disorder, drinking fell slightly more with oxytocin than placebo in weeks 9 to 12, a numerical difference only.

    Peptide
    Oxytocin
    Outcome
    DecreaseDrinking reduction in weeks 9 to 12
    Study

    n = 100

    Comparator
    Placebo
    Outcome group
    Addiction, withdrawal and alcohol intake · Mental health and mood
    Studied dose
    up to 70 IU/day · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    However, a small, numerically greater reduction in drinking was seen in the oxytocin group compared with placebo from weeks 9 to 12.
    1 context sentence
    Summary · context
    Oxytocin (up to 70 International Units [IU]/day) or placebo was administered to 100 individuals diagnosed with AUD in a double-blind, randomized, 12-week multisite trial.
  12. 12HumanRandomized controlled trialEfficacy outcome

    In adults with alcohol use disorder, participants given intranasal oxytocin scored significantly lower on anger at the end of treatment than those given placebo.

    In plain wordsIn adults with alcohol use disorder, people given oxytocin scored lower on anger at the end of treatment than those given placebo.

    Peptide
    Oxytocin
    Outcome
    DecreaseAnger
    Study

    n = 100

    Comparator
    Placebo
    Outcome group
    Anxiety and mood · Mental health and mood
    Studied dose
    up to 70 IU/day · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    At the end of treatment, participants receiving oxytocin scored significantly lower on measures of anger and physical aggression.
    1 context sentence
    Summary · context
    Oxytocin (up to 70 International Units [IU]/day) or placebo was administered to 100 individuals diagnosed with AUD in a double-blind, randomized, 12-week multisite trial.
  13. 13HumanRandomized controlled trialEfficacy outcome

    In adults with alcohol use disorder, participants given intranasal oxytocin scored significantly lower on physical aggression at the end of treatment than those given placebo.

    In plain wordsIn adults with alcohol use disorder, people given oxytocin scored lower on physical aggression at the end of treatment than those given placebo.

    Peptide
    Oxytocin
    Outcome
    DecreasePhysical aggression
    Study

    n = 100

    Comparator
    Placebo
    Outcome group
    Social behavior and cognition · Mental health and mood
    Studied dose
    up to 70 IU/day · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    At the end of treatment, participants receiving oxytocin scored significantly lower on measures of anger and physical aggression.
    1 context sentence
    Summary · context
    Oxytocin (up to 70 International Units [IU]/day) or placebo was administered to 100 individuals diagnosed with AUD in a double-blind, randomized, 12-week multisite trial.
  14. 14HumanRandomized controlled trialSafety outcome

    In adults with alcohol use disorder, hyposmia was the most common adverse event in both the oxytocin and placebo groups.

    In plain wordsIn adults with alcohol use disorder, reduced sense of smell was the most common side effect in both the oxytocin and placebo groups.

    Peptide
    Oxytocin
    Outcome
    Not applicableHyposmia
    Study

    n = 100

    Comparator
    Placebo
    Outcome group
    Adverse events · Respiratory
    Studied dose
    up to 70 IU/day · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    The most common event in both groups was hyposmia.
    1 context sentence
    Summary · context
    Oxytocin (up to 70 International Units [IU]/day) or placebo was administered to 100 individuals diagnosed with AUD in a double-blind, randomized, 12-week multisite trial.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2Results postedNCT03878316

Intranasal Oxytocin for the Treatment of Alcohol Use Disorder

National Institute on Alcohol Abuse and Alcoholism (NIAAA)n = 10029 Jun 2022 to 13 Oct 2023

Alcohol Use Disorder · Alcohol Misuse

Trial pageClinicalTrials.govUpdated 7 Aug 2025

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    11 Oct 2026, 00:50 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 02:47 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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