Intranasal Oxytocin for the Treatment of Alcohol Use Disorder
Randomized, Double Blind, Placebo-Controlled Trial of the Efficacy of Intranasal Oxytocin for the Treatment of Alcohol Use Disorder
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095
- University of California
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Maryland
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Baltimore, Maryland, United States, 21224
- Johns Hopkins School of Medicine
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Virginia
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Charlottesville, Virginia, United States, 22904
- University of Virginia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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,
- patch,
- double barrier (diaphragm/spermicidal or condom/spermicidal),
- intrauterine contraceptive system,
- etonogestrel implant,
- medroxyprogesterone acetate contraceptive injection,
- complete abstinence from sexual intercourse, and/or
- hormonal vaginal contraceptive ring.
- Be able to take intranasal investigational products and be willing to adhere to the investigational product regimen.
- Complete all assessments required at screening and baseline.
- 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.
- Not anticipate any significant problems with transportation arrangements or available time to travel to the study site by Study Week 14.
- Not have any plans to move within Study Week 14 to a location which would make continued participation in the study impractical.
- Not have any unresolved legal problems that could jeopardize continuation or completion of the study.
- 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.
- Be someone who in the opinion of the investigator would be expected to complete the study protocol.
- 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.
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
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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Intranasal Oxytocin - concentrated formulation - 35 IU per dose
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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.
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Intranasal Oxytocin - concentrated formulation - 35 IU per dose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Weeks 3-12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Subjects With no Heavy Drinking Days
Time Frame: weeks 3-12
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Percentage of subjects with no heavy drinking days during the 10-week Maintenance period
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weeks 3-12
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Percentage of Subjects Abstinent From Alcohol
Time Frame: Weeks 3-12
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Percentage of subjects abstinent from alcohol during the 10-week Maintenance period
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Weeks 3-12
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Percentage of Days Abstinent Per Week
Time Frame: weeks 3-12
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Timeline Follow Back daily drinking data used to calculate the % of days abstinent per week during the 10-week Maintenance period.
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weeks 3-12
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Weekly Mean Number of Drinks Per Week
Time Frame: weeks 3-12
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Weekly mean number of drinks per week during the 10-week Maintenance period.
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weeks 3-12
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Weekly Mean Drinks Per Drinking Day
Time Frame: weeks 3-12
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Weekly mean drinks per drinking day during the 10-week Maintenance period.
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weeks 3-12
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Number of Alcohol Use Disorder Symptoms (MINI)
Time Frame: week 13
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The MINI (paper version 7.0.2) is a short structured diagnostic interview, developed jointly by psychiatrists and clinicians in the United States and Europe, for DSM-5 and ICD-10 psychiatric disorders (Sheehan-1998).
This scale is a count of the number of alcohol use disorder symptoms.
Minimum = 0 and maximum=11.
Higher scores indicate worse outcome.
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week 13
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Cigarettes Smoked Per Week Among Smokers
Time Frame: weeks 3-12
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Cigarettes smoked per week among smokers during the 10-week Maintenance period.
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weeks 3-12
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Abstinence From Cigarette Smoking Among Smokers
Time Frame: weeks 3-12
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Abstinence from cigarette smoking among smokers during the 10-week Maintenance period.
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weeks 3-12
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Other Nicotine Product Use - Days Per Week Among Other Nicotine Product Users
Time Frame: weeks 3-12
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Other nicotine product use - days per week among other nicotine product users during the Maintenance period
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weeks 3-12
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Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) Scores (Attachment-related Anxiety Subscale)
Time Frame: weeks 3-12
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Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) scores (attachment-related anxiety subscale) during the 10-week Maintenance period.
Minimum = 0 and maximum = 126.
Higher scores are worse outcome.
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weeks 3-12
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PROMIS Sleep Disturbances Score
Time Frame: weeks 3-12
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PROMIS® (Patient-Reported Outcomes Measurement Information System) Sleep Disturbances score (Short Form 8b) during the 10-week Maintenance period.
Scores are T-scores with a mean of 50 and standard deviation of 10.
Minimum = 0 and maximum = 100.
Higher scores are worse outcome (i.e., more sleep disturbance).
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weeks 3-12
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PROMIS Alcohol-related Negative Consequences Score
Time Frame: weeks 3-12
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PROMIS® (Patient-Reported Outcomes Measurement Information System) alcohol-related negative consequences score (Long Form) during the 10-week Maintenance period.
Scores are T-scores with a mean of 50 and standard deviation of 10.
Minimum = 0 and maximum = 100.
Higher scores are worse outcome (i.e., more alcohol-related negative consequences).
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weeks 3-12
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PROMIS Pain Interference Score
Time Frame: weeks 3-12
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PROMIS® (Patient-Reported Outcomes Measurement Information System) Pain Interference score (Short Form 8a) during the 10-week Maintenance period.
Scores are T-scores with a mean of 50 and standard deviation of 10.
Minimum = 0 and maximum = 100.
Higher scores are worse outcome (i.e., more pain interference).
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weeks 3-12
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Profile of Moods States (POMS) - Total Mood Disturbance
Time Frame: weeks 3-12
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Profile of Moods States (POMS) - Total Mood Disturbance during the 10-week Maintenance period.
Minimum = -32 and maximum = 200.
Higher scores are worse outcome.
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weeks 3-12
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Urge to Drink Alcohol Craving Score
Time Frame: weeks 3-12
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Urge to Drink alcohol craving score during the 10-week Maintenance period.
Minimum = 0 and maximum = 35.
Higher scores are worse outcome.
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weeks 3-12
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Percentage of Subjects With at Least a 1-level World Health Organization (WHO) Drinking Risk Category Decrease
Time Frame: weeks 3-12
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Percentage of subjects with at least a 1-level World Health Organization (WHO) drinking risk category decrease from the baseline level to (the period including the 28 days before screening) to the level during the treatment phase (Study Weeks 3-12). The WHO levels of average alcohol consumption per day vary by Sex of participants and are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate "Abstinent" category. |
weeks 3-12
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Percentage of Subjects With at Least a 2-level World Health Organization (WHO) Drinking Risk Category Decrease
Time Frame: weeks 3-12
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Percentage of subjects with at least a 2-level World Health Organization (WHO) drinking risk category decrease from the baseline level to (the period including the 28 days before screening) to the level during the treatment phase (Study Weeks 3-12). The WHO levels of average alcohol consumption per day vary by Sex of participants and are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate "Abstinent" category. |
weeks 3-12
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Collaborators and Investigators
Investigators
- Principal Investigator: Raye Litten, PHD, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCIG 007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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