ITA: Intranasal Insulin for Treatment of Alcohol Use Disorder

• Sponsor: Brown University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05988632
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Anticipated Duration (Months): 12.3

Study Details

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.

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

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Sep 21, 2023
• Anticipated Primary Completion Date: Sep 20, 2024
• Anticipated Study Completion Date: Sep 30, 2024

Arms and Interventions

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 Names: 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 Names: Novolin R

Outcome Measures

Primary Outcome Measures

1. intranasal adverse events [From baseline to post-treatment (1 day)]

   Adverse event reported during the drug administration

Secondary Outcome Measures

1. insulin alcohol interaction [From baseline to post-treatment (1 day)]

   Adverse event reported during the alcohol administration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Brown University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Carolina Haass-Koffler, Associate Professor, Brown University
• ClinicalTrials.gov Identifier: NCT05988632
• Other Study ID Numbers: STUDY00000134
• First Posted: Aug 14, 2023
• Last Update Posted: Aug 14, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alcoholism; Alcohol Drinking; Insulin; Insulin, Globin Zinc

Study Results

No Results Posted as of Aug 14, 2023