Intranasal Insulin for Treatment of Alcohol Use Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Regular Human Insulin then Placebo, Placebo then Regular Human Insulin.
- Who it may be relevant to
- Registry conditions: Alcohol Use Disorder. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Regular Human Insulin then Placebo
Insulin: 80 IU (administered intranasally) THEN Placebo: 0.9% saline solution (administered intranasally) - Drug Placebo then Regular Human Insulin
Placebo: 0.9% saline solution (administered intranasally) THEN Insulin: 80 IU (administered intranasally)
Primary outcome measures
- intranasal adverse events [Time frame: From baseline to post-treatment (1 day)]
Secondary outcome measures (1)
- insulin alcohol interaction [Time frame: From baseline to post-treatment (1 day)]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Brown University — Providence
Publications
- Haass-Koffler CL, Kashyap B, Gully BJ, Nambiar SS, Hornbacher R, Foster SL, Silberman Y, Swift RM, Hanson LR, Frey WH 2nd. Intranasal insulin for the treatment of alcohol use disorder: design and methodology of an alcohol interaction randomized controlled trial. Contemp Clin Trials Commun. 2025 Jun 10;46:101509. doi: 10.1016/j.conctc.2025.101509. eCollection 2025 Aug. PMID 40584152
Identifiers
NCT: NCT05988632 · STUDY00000134