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Intranasal Insulin for Treatment of Alcohol Use Disorder (ITA)

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ClinicalTrials.gov Identifier: NCT05988632
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : March 26, 2024
Sponsor:
Information provided by (Responsible Party):
Carolina Haass-Koffler, Brown University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Drug: Regular Human Insulin then Placebo Drug: Placebo then Regular Human Insulin Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal Insulin for Treatment of Alcohol Use Disorder
Actual Study Start Date : March 25, 2024
Estimated Primary Completion Date : March 25, 2025
Estimated Study Completion Date : March 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Insulin, Then Placebo
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.
 Drug: Regular Human Insulin then Placebo
Insulin: 80 IU (administered intranasally) THEN Placebo: 0.9% saline solution (administered intranasally)
Other Name: Novolin R
Experimental: Placebo, Then Insulin
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.
 Drug: Placebo then Regular Human Insulin
Placebo: 0.9% saline solution (administered intranasally) THEN Insulin: 80 IU (administered intranasally)
Other Name: Novolin R


Outcome Measures
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Primary Outcome Measures :
  1. intranasal adverse events [ Time Frame: From baseline to post-treatment (1 day) ]
    Adverse event reported during the drug administration


Secondary Outcome Measures :
  1. insulin alcohol interaction [ Time Frame: From baseline to post-treatment (1 day) ]
    Adverse event reported during the alcohol administration


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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): NCT05988632


Contacts
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Contact: Carolina L Haass-Koffler 4155191385 carolina_haass-koffler@brown.edu

Locations
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United States, Rhode Island
Brown University Recruiting
Providence, Rhode Island, United States, 02903
Contact: Zoe Brown    401-863-6646    alcohol-stress-study@brown.edu   
Contact: Brian Gully    (401) 863-6646    alcohol-stress-study@brown.edu   
Sponsors and Collaborators
Brown University
More Information
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Responsible Party: Carolina Haass-Koffler, Associate Professor, Brown University
ClinicalTrials.gov Identifier: NCT05988632    
Other Study ID Numbers: STUDY00000134
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: March 26, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs