Intranasal Insulin for Treatment of Alcohol Use Disorder

Last updated: March 25, 2024
Sponsor: Brown University
Overall Status: Active - Recruiting

Phase

1/2

Condition

Alcohol Use Disorder

Addictions

Substance Abuse

Treatment

Placebo then Regular Human Insulin

Regular Human Insulin then Placebo

Clinical Study ID

NCT05988632
STUDY00000134
  • Ages > 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofalcohol that will be administered in the laboratory procedure (i.e. to reach BrAClevels 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 laboratoryprocedures

Exclusion

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 orcannabis)
  • use of drugs (e.g. stimulants/opioids) at each alcohol administration session (byurine tox screen)
  • cannabis intoxication (by clinical assessments)
  • use of medications that may interact with insulin and alcohol (by Micromedexdatabase)
  • 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)

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo then Regular Human Insulin
Phase: 1/2
Study Start date:
March 25, 2024
Estimated Completion Date:
March 30, 2025

Study 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.

Connect with a study center

  • Brown University

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

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