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Intranasal Oxytocin for the Treatment of Alcohol Use Disorder
Phase 2 trial testing Instranasal Oxytocin in Alcohol Use Disorder in 100 participants. Completed in 13 October 2023.
| Lead sponsor | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 29 June 2022 |
| Primary completion | 13 October 2023 |
| Estimated completion | 13 October 2023 |
| Sites | 4 locations across United States |
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
18 and older, any sex, with Alcohol Use Disorder or Alcohol Misuse. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Intranasal Oxytocin | 51.5 | ± 3.9 |
| Instrasal Placebo | 52.9 | ± 3.9 |
Percentage of subjects with no heavy drinking days during the 10-week Maintenance period
| Group | Value | 95% CI |
|---|---|---|
| Intranasal Oxytocin | 2.1 | |
| Instrasal Placebo | 6.3 |
Percentage of subjects abstinent from alcohol during the 10-week Maintenance period
| Group | Value | 95% CI |
|---|---|---|
| Intranasal Oxytocin | 0 | |
| Instrasal Placebo | 2.1 |
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, comp
| Group | Value | 95% CI |
|---|---|---|
| Intranasal Oxytocin | 59.6 | |
| Instrasal Placebo | 53.2 |
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, comp
| Group | Value | 95% CI |
|---|---|---|
| Intranasal Oxytocin | 23.4 | |
| Instrasal Placebo | 23.4 |
Timeline Follow Back daily drinking data used to calculate the % of days abstinent per week during the 10-week Maintenance period.
| Group | Value | 95% CI |
|---|---|---|
| Intranasal Oxytocin | 23.2 | ± 2.5 |
| Instrasal Placebo | 22.6 | ± 2.5 |
Weekly mean number of drinks per week during the 10-week Maintenance period.
| Group | Value | 95% CI |
|---|---|---|
| Intranasal Oxytocin | 33.1 | ± 2.2 |
| Instrasal Placebo | 34.7 | ± 2.3 |
Weekly mean drinks per drinking day during the 10-week Maintenance period.
| Group | Value | 95% CI |
|---|---|---|
| Intranasal Oxytocin | 6.2 | ± 0.3 |
| Instrasal Placebo | 6.3 | ± 0.3 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intranasal Oxytocin | 3.9 | ± 0.3 |
| Instrasal Placebo | 4.2 | ± 0.3 |
Cigarettes smoked per week among smokers during the 10-week Maintenance period.
| Group | Value | 95% CI |
|---|---|---|
| Intranasal Oxytocin | 40.6 | ± 32.1 |
| Instrasal Placebo | 45.9 | ± 52.8 |
Abstinence from cigarette smoking among smokers during the 10-week Maintenance period.
| Group | Value | 95% CI |
|---|---|---|
| Intranasal Oxytocin | 0 | |
| Instrasal Placebo | 0 |
Other nicotine product use - days per week among other nicotine product users during the Maintenance period
| Group | Value | 95% CI |
|---|---|---|
| Intranasal Oxytocin | 4.9 | ± 1.9 |
| Instrasal Placebo | 5.4 | ± 2.3 |
Time frame: AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Intranasal Oxytocin | Instrasal Placebo |
|---|---|---|---|
| Hyposmia | Nervous system disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Headache | Nervous system disorders | — | — |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Hyperkalaemia | Metabolism and nutrition disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Bradycardia | Cardiac disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Hypernatraemia | Metabolism and nutrition disorders | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | — | — |
| Erythema | Skin and subcutaneous tissue disorders | — | — |
| Tachycardia | Cardiac disorders | — | — |
| Chills | General disorders | — | — |
| Fatigue | General disorders | — | — |
| Pain | General disorders | — | — |
| Pyrexia | General disorders | — | — |
| COVID-19 | Infections and infestations | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Blood creatinine increased | Investigations | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Abnormal dreams | Psychiatric disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Depression | Psychiatric disorders | — | — |
| Nasal septum disorder | Respiratory, thoracic and mediastinal disorders | — | — |
| Palpitations | Cardiac disorders | — | — |
| Ear pain | Ear and labyrinth disorders | — | — |
| Tinnitus | Ear and labyrinth disorders | — | — |
Data from ClinicalTrials.gov NCT03878316 adverse events section.
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.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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