Intranasal Oxytocin for the Treatment of Alcohol Use Disorder
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|ClinicalTrials.gov Identifier: NCT03878316|
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : August 4, 2022
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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.
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder Alcohol Misuse||Drug: Instranasal Oxytocin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized, Double Blind, Placebo-Controlled Trial of the Efficacy of Intranasal Oxytocin for the Treatment of Alcohol Use Disorder|
|Actual Study Start Date :||May 5, 2022|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||March 2024|
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
- Weekly Percentage of Heavy Drinking Days [ Time Frame: 10 Weeks ]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.
- Percentage of subjects with no heavy drinking days during treatment [ Time Frame: 10 Weeks ]
- Percentage of subjects abstinent from alcohol during treatment [ Time Frame: 10 weeks ]
- Percentage of subjects with at least a 1-level World Health Organization WHO) drinking risk category decrease [ Time Frame: 10 weeks ]
- Percentage of subjects with at least a 2-level World Health Organization WHO) drinking risk category decrease [ Time Frame: 10 weeks ]
- Percentage of days abstinent from alcohol per week [ Time Frame: 10 weeks ]
- Weekly mean number of drinks per week [ Time Frame: 12 weeks ]
- Weekly mean drinks per drinking day [ Time Frame: 10 weeks ]
- MINI AUD Score at end of study [ Time Frame: 12 weeks ]
- Cigarettes smoked per week among smokers [ Time Frame: 10 weeks ]
- Abstinence from cigarette smoking among smokers [ Time Frame: 12 weeks ]
- Other nicotine product use per week among other nicotine product users [ Time Frame: 10 weeks ]
- Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) scores (attachment-related anxiety) [ Time Frame: 12 weeks ]
- PROMIS sleep disturbances scores [ Time Frame: 10 weeks ]
- PROMIS alcohol-related negative consequences scores [ Time Frame: 10 weeks ]
- PROMIS pain interference scores [ Time Frame: 10 weeks ]
- Profile of Moods States (POMS) scores (including subscale scores) [ Time Frame: 10 weeks ]
- Urge to Drink Scores [ Time Frame: 10 weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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,
- 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:
- Dual uptake inhibitors
- Tricyclic antidepressants
- Not currently taking oxytocin and agree not to take non-study oxytocin for the duration of the study.
Contact study site for exclusion criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878316
|Contact: Megan Ryan, MBAfirstname.lastname@example.org|
|United States, California|
|University of California||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Jessica Jenkins, MS 310-206-6756 email@example.com|
|Principal Investigator: Lara Ray, PhD|
|United States, Maryland|
|Johns Hopkins School of Medicine||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Caitlyn Grubb 410-550-0490 firstname.lastname@example.org|
|Principal Investigator: Eric Strain, MD|
|United States, Massachusetts|
|Boston Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02118|
|Contact: Alyssa Pingitore 617-414-1914 email@example.com|
|Principal Investigator: Eric Devine, PhD|
|United States, Virginia|
|University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22904|
|Contact: Eva Jenkins-Mendoza 434-243-0562 firstname.lastname@example.org|
|Principal Investigator: Nassima Ait-Daoud Tiouririne, MD|
|Principal Investigator:||Raye Litten, PHD||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|
|Responsible Party:||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|
|Other Study ID Numbers:||
|First Posted:||March 18, 2019 Key Record Dates|
|Last Update Posted:||August 4, 2022|
|Last Verified:||August 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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