Alcohol Use DisorderPhase 2NCT03878316
Intranasal Oxytocin for the Treatment of Alcohol Use Disorder
A Phase 2 study testing Instranasal Oxytocin in people with Alcohol Use Disorder and Alcohol Misuse, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Misuse
- What is being tested?
- Instranasal Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Jun 2022to 13 Oct 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 32Show fewer
- 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.
- Be able to take intranasal investigational products and be willing to adhere to the investigational product regimen.
- Complete all assessments required at screening and baseline.
- 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.
- Not anticipate any significant problems with transportation arrangements or available time to travel to the study site by Study Week 14.
- Not have any plans to move within Study Week 14 to a location which would make continued participation in the study impractical.
- Not have any unresolved legal problems that could jeopardize continuation or completion of the study.
- 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.
- Be someone who in the opinion of the investigator would be expected to complete the study protocol.
- 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.
- 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
- Not currently taking oxytocin and agree not to take non-study oxytocin for the duration of the study.
Who cannot join
- Contact study site for exclusion criteria.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins School of Medicine
Baltimore, Maryland, 21224
Boston Medical Center
Boston, Massachusetts, 02118
University of Virginia
Charlottesville, Virginia, 22904
University of California
Los Angeles, California, 90095
About this study
Official title: Randomized, Double Blind, Placebo-Controlled Trial of the Efficacy of Intranasal Oxytocin for the Treatment of Alcohol Use Disorder
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
- Being tested
- Instranasal Oxytocin
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instranasal OxytocinDrug
Intranasal Oxytocin - concentrated formulation - 35 IU per dose
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Instranasal Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 3-12
Secondary outcomes (17)
Percentage of Subjects With no Heavy Drinking Days
Percentage of subjects with no heavy drinking days during the 10-week Maintenance period
Measured: weeks 3-12
Percentage of Subjects Abstinent From Alcohol
Percentage of subjects abstinent from alcohol during the 10-week Maintenance period
Measured: Weeks 3-12
Percentage of Subjects With at Least a 1-level World Health Organization (WHO) Drinking Risk Category Decrease
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.
Measured: weeks 3-12
Percentage of Subjects With at Least a 2-level World Health Organization (WHO) Drinking Risk Category Decrease
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.
Measured: weeks 3-12
Percentage of Days Abstinent Per Week
Timeline Follow Back daily drinking data used to calculate the % of days abstinent per week during the 10-week Maintenance period.
Measured: weeks 3-12
Weekly Mean Number of Drinks Per Week
Weekly mean number of drinks per week during the 10-week Maintenance period.
Measured: weeks 3-12
Weekly Mean Drinks Per Drinking Day
Weekly mean drinks per drinking day during the 10-week Maintenance period.
Measured: weeks 3-12
Number of Alcohol Use Disorder Symptoms (MINI)
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.
Measured: week 13
Cigarettes Smoked Per Week Among Smokers
Cigarettes smoked per week among smokers during the 10-week Maintenance period.
Measured: weeks 3-12
Abstinence From Cigarette Smoking Among Smokers
Abstinence from cigarette smoking among smokers during the 10-week Maintenance period.
Measured: weeks 3-12
Other Nicotine Product Use - Days Per Week Among Other Nicotine Product Users
Other nicotine product use - days per week among other nicotine product users during the Maintenance period
Measured: weeks 3-12
Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) Scores (Attachment-related Anxiety Subscale)
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.
Measured: weeks 3-12
PROMIS Sleep Disturbances Score
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).
Measured: weeks 3-12
PROMIS Alcohol-related Negative Consequences Score
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).
Measured: weeks 3-12
PROMIS Pain Interference Score
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).
Measured: weeks 3-12
Profile of Moods States (POMS) - Total Mood Disturbance
Profile of Moods States (POMS) - Total Mood Disturbance during the 10-week Maintenance period. Minimum = -32 and maximum = 200. Higher scores are worse outcome.
Measured: weeks 3-12
Urge to Drink Alcohol Craving Score
Urge to Drink alcohol craving score during the 10-week Maintenance period. Minimum = 0 and maximum = 35. Higher scores are worse outcome.
Measured: weeks 3-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start29 Jun 2022
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Raye Litten, PHD, Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878316
- Sponsor's protocol ID
- NCIG 007
- Status last verified
- Jul 2025
- First submitted
- 14 Mar 2019
- Last updated
- 7 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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. Intranasal Oxytocin for Alcohol Use Disorder: A Randomized, Double-Blind, Placebo-Controlled Multisite Trial Assessing Efficacy and Safety. Alcohol Clin Exp Res (Hoboken). 2026 Jul;50(7):e70326. doi: 10.1111/acer.70326.
PubMed 42458234
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo-Controlled Trial of the Efficacy of Intranasal Oxytocin for the Treatment of Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT03878316
- Acronym / sponsor ID
- NCIG 007
- Conditions
- Alcohol Use Disorder, Alcohol Misuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Posted 23 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal Oxytocin | Active comparator | Drug: Instranasal 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. |
| Instrasal Placebo | Placebo comparator | Drug: Instranasal OxytocinIdentically 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- 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.
Key exclusion criteria (1 listed)
- Contact study site for exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instranasal OxytocinIntranasal Oxytocin - concentrated formulation - 35 IU per dose | Drug | Instrasal Placebo, Intranasal Oxytocin |
Primary outcome
Weekly Percentage of Heavy Drinking Days
Time frame: Weeks 3-12
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.
17 secondary outcomes
Percentage of Subjects With no Heavy Drinking Days
Time frame: weeks 3-12
Percentage of Subjects Abstinent From Alcohol
Time frame: Weeks 3-12
Percentage of Subjects With at Least a 1-level World Health Organization (WHO) Drinking Risk Category Decrease
Time frame: weeks 3-12
Percentage of Subjects With at Least a 2-level World Health Organization (WHO) Drinking Risk Category Decrease
Time frame: weeks 3-12
Percentage of Days Abstinent Per Week
Time frame: weeks 3-12
Weekly Mean Number of Drinks Per Week
Time frame: weeks 3-12
Weekly Mean Drinks Per Drinking Day
Time frame: weeks 3-12
Number of Alcohol Use Disorder Symptoms (MINI)
Time frame: week 13
Cigarettes Smoked Per Week Among Smokers
Time frame: weeks 3-12
Abstinence From Cigarette Smoking Among Smokers
Time frame: weeks 3-12
Other Nicotine Product Use - Days Per Week Among Other Nicotine Product Users
Time frame: weeks 3-12
Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) Scores (Attachment-related Anxiety Subscale)
Time frame: weeks 3-12
PROMIS Sleep Disturbances Score
Time frame: weeks 3-12
PROMIS Alcohol-related Negative Consequences Score
Time frame: weeks 3-12
PROMIS Pain Interference Score
Time frame: weeks 3-12
Profile of Moods States (POMS) - Total Mood Disturbance
Time frame: weeks 3-12
Urge to Drink Alcohol Craving Score
Time frame: weeks 3-12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42458234Tiouririne 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. Intranasal Oxytocin for Alcohol Use Disorder: A Randomized, Double-Blind, Placebo-Controlled Multisite Trial Assessing Efficacy and Safety. Alcohol Clin Exp Res (Hoboken). 2026 Jul;50(7):e70326. doi: 10.1111/acer.70326.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raye Litten, PHD principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Instranasal Oxytocin in people with Alcohol Use Disorder and Alcohol Misuse, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly Percentage of Heavy Drinking Days (time frame: Weeks 3-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03878316, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.