Intranasal Insulin for Treatment of Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

— ITA  

Official title:

Intranasal Insulin for Treatment of Alcohol Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05988632
• Other study ID #: STUDY00000134
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 25, 2024
• Est. completion date: March 30, 2025

Study information

• Verified date: March 2024
• Source: Brown University
• Contact: Carolina L Haass-Koffler
• Phone: 4155191385
• Email: carolina_haass-koffler[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 30, 2025
• Est. primary completion date: March 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• Regular Human Insulin then Placebo
Insulin: 80 IU (administered intranasally) THEN Placebo: 0.9% saline solution (administered intranasally)
• Placebo then Regular Human Insulin
Placebo: 0.9% saline solution (administered intranasally) THEN Insulin: 80 IU (administered intranasally)

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intranasal adverse events	Adverse event reported during the drug administration	From baseline to post-treatment (1 day)
Secondary	insulin alcohol interaction	Adverse event reported during the alcohol administration	From baseline to post-treatment (1 day)