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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
Sponsor:
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Alcohol Misuse Drug: Instranasal Oxytocin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
Drug Information available for: Oxytocin

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Percentage of subjects with no heavy drinking days during treatment [ Time Frame: 10 Weeks ]
  2. Percentage of subjects abstinent from alcohol during treatment [ Time Frame: 10 weeks ]
  3. Percentage of subjects with at least a 1-level World Health Organization WHO) drinking risk category decrease [ Time Frame: 10 weeks ]
  4. Percentage of subjects with at least a 2-level World Health Organization WHO) drinking risk category decrease [ Time Frame: 10 weeks ]
  5. Percentage of days abstinent from alcohol per week [ Time Frame: 10 weeks ]
  6. Weekly mean number of drinks per week [ Time Frame: 12 weeks ]
  7. Weekly mean drinks per drinking day [ Time Frame: 10 weeks ]
  8. MINI AUD Score at end of study [ Time Frame: 12 weeks ]
  9. Cigarettes smoked per week among smokers [ Time Frame: 10 weeks ]
  10. Abstinence from cigarette smoking among smokers [ Time Frame: 12 weeks ]
  11. Other nicotine product use per week among other nicotine product users [ Time Frame: 10 weeks ]
  12. Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) scores (attachment-related anxiety) [ Time Frame: 12 weeks ]
  13. PROMIS sleep disturbances scores [ Time Frame: 10 weeks ]
  14. PROMIS alcohol-related negative consequences scores [ Time Frame: 10 weeks ]
  15. PROMIS pain interference scores [ Time Frame: 10 weeks ]
  16. Profile of Moods States (POMS) scores (including subscale scores) [ Time Frame: 10 weeks ]
  17. Urge to Drink Scores [ Time Frame: 10 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Megan Ryan, MBA 3014434225 mryan1@nih.gov

Locations
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United States, California
University of California Recruiting
Los Angeles, California, United States, 90095
Contact: Jessica Jenkins, MS    310-206-6756    jenkinsj@ucla.edu   
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    cgrubb7@jhmi.edu   
Principal Investigator: Eric Strain, MD         
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Alyssa Pingitore    617-414-1914    alyssa.pingitore@bmc.org   
Principal Investigator: Eric Devine, PhD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22904
Contact: Eva Jenkins-Mendoza    434-243-0562    emj9c@hscmail.mcc.virginia.edu   
Principal Investigator: Nassima Ait-Daoud Tiouririne, MD         
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Raye Litten, PHD National Institute on Alcohol Abuse and Alcoholism (NIAAA)
More Information
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Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT03878316    
Other Study ID Numbers: NCIG 007
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: August 4, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
 Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs