NCT05988632 · Brown University
Intranasal Insulin for Treatment of Alcohol Use Disorder
(ITA)
What this study is about
This is a randomly assigned controlled trial (RCT), within-subject, crossover, where neither patients nor doctors know which treatment is given, compared against an inactive treatment in non-treatment-seeking individuals with Alcohol Use Disorder (AUD) (N=40, 50% female) randomly assigned to IN insulin or placebo.
View original scientific description
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.
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)
Adverse event reported during the drug administration
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
Where
- Providence, Rhode Island
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 5, 2025 · Source of record for eligibility and locations