Clinical trial NCT03878316: Intranasal Oxytocin for the Treatment of Alcohol Use Disorder
Official title: Randomized, Double Blind, Placebo-Controlled Trial of the Efficacy of Intranasal Oxytocin for the Treatment of Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Use Disorder
Alcohol Misuse
Lead sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor class: NIH
First posted: 2019-03-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Weekly Percentage of Heavy Drinking Days
timeFrame: 10 Weeks
Secondary outcomes:
measure: Percentage of subjects with no heavy drinking days during treatment
timeFrame: 10 Weeks
measure: Percentage of subjects abstinent from alcohol during treatment
timeFrame: 10 weeks
measure: Percentage of subjects with at least a 1-level World Health Organization WHO) drinking risk category decrease
timeFrame: 10 weeks
measure: Percentage of subjects with at least a 2-level World Health Organization WHO) drinking risk category decrease
timeFrame: 10 weeks
measure: Percentage of days abstinent from alcohol per week
timeFrame: 10 weeks
measure: Weekly mean number of drinks per week
timeFrame: 12 weeks
measure: Weekly mean drinks per drinking day
timeFrame: 10 weeks
measure: MINI AUD Score at end of study
timeFrame: 12 weeks
measure: Cigarettes smoked per week among smokers
timeFrame: 10 weeks
measure: Abstinence from cigarette smoking among smokers
timeFrame: 12 weeks
measure: Other nicotine product use per week among other nicotine product users
timeFrame: 10 weeks
measure: Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) scores (attachment-related anxiety)
timeFrame: 12 weeks
measure: PROMIS sleep disturbances scores
timeFrame: 10 weeks
measure: PROMIS alcohol-related negative consequences scores
timeFrame: 10 weeks
measure: PROMIS pain interference scores
timeFrame: 10 weeks
measure: Profile of Moods States (POMS) scores (including subscale scores)
timeFrame: 10 weeks
measure: Urge to Drink Scores
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California
state: California
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Raye Litten, PHD
role: PRINCIPAL_INVESTIGATOR
References: