Intranasal Oxytocin for the Treatment of Alcohol Use Disorder

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) assessedusing 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 consentdocument (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 writteninformed consent, verbalize willingness to complete study procedures, able tounderstand written and oral instructions in English and able to complete thequestionnaires required by the protocol.

6. Agree (if the subject is female and of child bearing potential) to use at least oneof the following methods of birth control, unless she is surgically sterile, partneris surgically sterile or she is postmenopausal:

7. oral contraceptives,

8. contraceptive sponge,

9. patch,

10. double barrier (diaphragm/spermicidal or condom/spermicidal),

11. intrauterine contraceptive system,

12. etonogestrel implant,

13. medroxyprogesterone acetate contraceptive injection,

14. complete abstinence from sexual intercourse, and/or

15. hormonal vaginal contraceptive ring.

16. Be able to take intranasal investigational products and be willing to adhere to theinvestigational product regimen.

17. Complete all assessments required at screening and baseline.

18. Have a place to live in the 2 weeks prior to randomization and not be at risk thats/he will lose his/her housing by Study Week 14.

19. Not anticipate any significant problems with transportation arrangements oravailable time to travel to the study site by Study Week 14.

20. Not have any plans to move within Study Week 14 to a location which would makecontinued participation in the study impractical.

21. Not have any unresolved legal problems that could jeopardize continuation orcompletion of the study.

22. Provide contact information of someone, such as a family member, spouse, orsignificant other, who may be able to contact the subject in case of a missed clinicappointment.

23. Be someone who in the opinion of the investigator would be expected to complete thestudy protocol.

24. Agree to the schedule of visits, verbally acknowledge that s/he will be able toattend each scheduled visit, participate in phone visits and that s/he does not haveany already scheduled events or a job that may substantially interfere with studyparticipation.

25. If taking a medication for depression or anxiety, must have been taking a stabledose 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 theduration of the study.

Exclusion Criteria:

Contact study site for exclusion criteria.