Intranasal Insulin for Treatment of Alcohol Use Disorder
ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorBrown University
About this trial
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
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
• 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)
Trial design
Design model
Crossover
Treatments tested in this trial
Regular Human Insulin then Placebo
DrugInsulin: 80 IU (administered intranasally) THEN Placebo: 0.9% saline solution (administered intranasally)
Placebo then Regular Human Insulin
DrugPlacebo: 0.9% saline solution (administered intranasally) THEN Insulin: 80 IU (administered intranasally)
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Insulin, Then PlaceboExperimental treatment 1 intervention
Group B: Placebo, Then InsulinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
intranasal adverse events
Adverse event reported during the drug administration
Time frame
From baseline to post-treatment (1 day)Secondary outcomes
1
insulin alcohol interaction
Adverse event reported during the alcohol administration
Time frame
From baseline to post-treatment (1 day)Sponsors and contacts
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Source ClinicalTrials.gov