Intranasal Oxytocin for the Treatment of Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

Official title:

Randomized, Double Blind, Placebo-Controlled Trial of the Efficacy of Intranasal Oxytocin for the Treatment of Alcohol Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03878316
• Other study ID #: NCIG 007
• Status: Recruiting
• Phase: Phase 2
• Start date: May 5, 2022
• Est. completion date: March 2024

Study information

• Verified date: June 2023
• Source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Contact: Megan Ryan, MBA
• Phone: 3014434225
• Email: mryan1[@]nih.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Misuse
• Alcohol Use Disorder
• Alcoholism

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland
United States	Boston Medical Center	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	University of California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 Weeks
Secondary	Percentage of subjects with no heavy drinking days during treatment		10 Weeks
Secondary	Percentage of subjects abstinent from alcohol during treatment		10 weeks
Secondary	Percentage of subjects with at least a 1-level World Health Organization WHO) drinking risk category decrease		10 weeks
Secondary	Percentage of subjects with at least a 2-level World Health Organization WHO) drinking risk category decrease		10 weeks
Secondary	Percentage of days abstinent from alcohol per week		10 weeks
Secondary	Weekly mean number of drinks per week		12 weeks
Secondary	Weekly mean drinks per drinking day		10 weeks
Secondary	MINI AUD Score at end of study		12 weeks
Secondary	Cigarettes smoked per week among smokers		10 weeks
Secondary	Abstinence from cigarette smoking among smokers		12 weeks
Secondary	Other nicotine product use per week among other nicotine product users		10 weeks
Secondary	Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) scores (attachment-related anxiety)		12 weeks
Secondary	PROMIS sleep disturbances scores		10 weeks
Secondary	PROMIS alcohol-related negative consequences scores		10 weeks
Secondary	PROMIS pain interference scores		10 weeks
Secondary	Profile of Moods States (POMS) scores (including subscale scores)		10 weeks
Secondary	Urge to Drink Scores		10 weeks