Randomized, Double Blind, Placebo-Controlled Trial of the Efficacy of Intranasal Oxytocin for the Treatment of Alcohol Use Disorder
Overview
- Phase
- Phase 2
- Intervention
- Instranasal Oxytocin
- Conditions
- Alcohol Use Disorder
- Sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- Weekly Percentage of Heavy Drinking Days
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
- •oral contraceptives,
- •contraceptive sponge,
- •double barrier (diaphragm/spermicidal or condom/spermicidal),
- •intrauterine contraceptive system,
Exclusion Criteria
- •Contact study site for exclusion criteria.
Arms & Interventions
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.
Intervention: Instranasal Oxytocin
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.
Intervention: Instranasal Oxytocin
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Percentage of Subjects With no Heavy Drinking Days(weeks 3-12)
- Percentage of Subjects Abstinent From Alcohol(Weeks 3-12)
- Percentage of Subjects With at Least a 1-level World Health Organization (WHO) Drinking Risk Category Decrease(weeks 3-12)
- Percentage of Days Abstinent Per Week(weeks 3-12)
- Weekly Mean Number of Drinks Per Week(weeks 3-12)
- PROMIS Pain Interference Score(weeks 3-12)
- Profile of Moods States (POMS) - Total Mood Disturbance(weeks 3-12)
- Urge to Drink Alcohol Craving Score(weeks 3-12)
- Percentage of Subjects With at Least a 2-level World Health Organization (WHO) Drinking Risk Category Decrease(weeks 3-12)
- Number of Alcohol Use Disorder Symptoms (MINI)(week 13)
- Cigarettes Smoked Per Week Among Smokers(weeks 3-12)
- Abstinence From Cigarette Smoking Among Smokers(weeks 3-12)
- Other Nicotine Product Use - Days Per Week Among Other Nicotine Product Users(weeks 3-12)
- Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) Scores (Attachment-related Anxiety Subscale)(weeks 3-12)
- PROMIS Sleep Disturbances Score(weeks 3-12)
- PROMIS Alcohol-related Negative Consequences Score(weeks 3-12)
- Weekly Mean Drinks Per Drinking Day(weeks 3-12)