search
Back to results

Intranasal Insulin for Treatment of Alcohol Use Disorder (ITA)

Primary Purpose

Alcohol Use Disorder

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Regular Human Insulin then Placebo
Placebo then Regular Human Insulin
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥21 years meet any DSM-5 criteria score for AUD Individuals who, in the last month, have consumed at least the same amount of alcohol that will be administered in the laboratory procedure (i.e. to reach BrAC levels of 0.08g/dl, ~two drinks in one occasion) BrAC=0.00g/dL at each visit good health as confirmed by medical history, physical examination and lab tests willing to adhere to the study procedures understand informed consent and questionnaires in English at an 8th grade level willing to have glucose monitored by finger stick during the laboratory procedures Exclusion Criteria: • female identifying who are breastfeeding or pregnant (assessed by a urine screen) individuals with diabetes history of suicide attempts in the last three years current diagnosis of other substance use disorder (other than nicotine or cannabis) use of drugs (e.g. stimulants/opioids) at each alcohol administration session (by urine tox screen) cannabis intoxication (by clinical assessments) use of medications that may interact with insulin and alcohol (by Micromedex database) hypersensitivity to insulin any nasal disease/congestion that may interfere with intranasal drug absorption; baseline hypoglycemia (blood glucose ≤65mg/dL) or hyperglycemia (blood glucose >200mg/dL) (by finger stick)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Insulin, Then Placebo

    Placebo, Then Insulin

    Arm Description

    There will be one single administration of intranasal human insulin (80IU) before alcohol self-administration. After a one week washout period, there will be one single intranasal administration of placebo (saline, 0.9% solution) before alcohol self administration.

    There will be one single intranasal administration of placebo (saline, 0.9% solution) before alcohol self administration. After a one week washout period, there will be one single administration of intranasal human insulin (80IU) before alcohol self-administration.

    Outcomes

    Primary Outcome Measures

    intranasal adverse events
    Adverse event reported during the drug administration

    Secondary Outcome Measures

    insulin alcohol interaction
    Adverse event reported during the alcohol administration

    Full Information

    First Posted
    July 25, 2023
    Last Updated
    August 9, 2023
    Sponsor
    Brown University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05988632
    Brief Title
    Intranasal Insulin for Treatment of Alcohol Use Disorder
    Acronym
    ITA
    Official Title
    Intranasal Insulin for Treatment of Alcohol Use Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 21, 2023 (Anticipated)
    Primary Completion Date
    September 20, 2024 (Anticipated)
    Study Completion Date
    September 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brown University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a randomized controlled trial (RCT), within-subject, crossover, double-blind, placebo-controlled in non-treatment-seeking individuals with Alcohol Use Disorder (AUD) (N=40, 50% female) randomized to IN insulin or placebo. In a bar laboratory setting, randomized participants will receive a single dose of IN insulin (80IU) or an IN matched placebo (0.9% Saline). Participants will undergo a cue-reactivity paradigm followed by an alcohol challenge that includes an alcohol drink designed to raise the breath alcohol content (BrAC) to 0.08g/dL.
    Detailed Description
    Aims in this RCT testing the effect of IN insulin, compared to placebo, in individuals with AUD include the following: AIM 1: to assess the safety, tolerability and acceptability of IN insulin as a pharmacological intervention for AUD. The data collected in this aim will monitor possible adverse events and yield qualitative and quantitative data to finalize the feasibility and acceptability of IN insulin as an AUD pharmacotherapy. Aim 2 (alcohol-drug interaction): to assess the safety and tolerability of IN insulin when administered with alcohol. The investigators will use a battery of physiological/psychological assessments that measures potential adverse events, alcohol subjective response and alcohol pharmacokinetics endpoints.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Use Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Insulin, Then Placebo
    Arm Type
    Experimental
    Arm Description
    There will be one single administration of intranasal human insulin (80IU) before alcohol self-administration. After a one week washout period, there will be one single intranasal administration of placebo (saline, 0.9% solution) before alcohol self administration.
    Arm Title
    Placebo, Then Insulin
    Arm Type
    Experimental
    Arm Description
    There will be one single intranasal administration of placebo (saline, 0.9% solution) before alcohol self administration. After a one week washout period, there will be one single administration of intranasal human insulin (80IU) before alcohol self-administration.
    Intervention Type
    Drug
    Intervention Name(s)
    Regular Human Insulin then Placebo
    Other Intervention Name(s)
    Novolin R
    Intervention Description
    Insulin: 80 IU (administered intranasally) THEN Placebo: 0.9% saline solution (administered intranasally)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo then Regular Human Insulin
    Other Intervention Name(s)
    Novolin R
    Intervention Description
    Placebo: 0.9% saline solution (administered intranasally) THEN Insulin: 80 IU (administered intranasally)
    Primary Outcome Measure Information:
    Title
    intranasal adverse events
    Description
    Adverse event reported during the drug administration
    Time Frame
    From baseline to post-treatment (1 day)
    Secondary Outcome Measure Information:
    Title
    insulin alcohol interaction
    Description
    Adverse event reported during the alcohol administration
    Time Frame
    From baseline to post-treatment (1 day)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ≥21 years meet any DSM-5 criteria score for AUD Individuals who, in the last month, have consumed at least the same amount of alcohol that will be administered in the laboratory procedure (i.e. to reach BrAC levels of 0.08g/dl, ~two drinks in one occasion) BrAC=0.00g/dL at each visit good health as confirmed by medical history, physical examination and lab tests willing to adhere to the study procedures understand informed consent and questionnaires in English at an 8th grade level willing to have glucose monitored by finger stick during the laboratory procedures Exclusion Criteria: • female identifying who are breastfeeding or pregnant (assessed by a urine screen) individuals with diabetes history of suicide attempts in the last three years current diagnosis of other substance use disorder (other than nicotine or cannabis) use of drugs (e.g. stimulants/opioids) at each alcohol administration session (by urine tox screen) cannabis intoxication (by clinical assessments) use of medications that may interact with insulin and alcohol (by Micromedex database) hypersensitivity to insulin any nasal disease/congestion that may interfere with intranasal drug absorption; baseline hypoglycemia (blood glucose ≤65mg/dL) or hyperglycemia (blood glucose >200mg/dL) (by finger stick)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carolina L Haass-Koffler
    Phone
    4155191385
    Email
    carolina_haass-koffler@brown.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Intranasal Insulin for Treatment of Alcohol Use Disorder

    We'll reach out to this number within 24 hrs