Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Instranasal Oxytocin
    Intranasal Oxytocin - concentrated formulation - 35 IU per dose
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.
  • Drug: Instranasal Oxytocin
    Intranasal Oxytocin - concentrated formulation - 35 IU per dose

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Alyssa Pingitore
617-414-1914
alyssa.pingitore@bmc.org

More Details

Status
Recruiting
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Contact

Megan Ryan, MBA
3014434225
mryan1@nih.gov

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.