Intranasal Insulin for Treatment of Alcohol Use Disorder

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Brown University
Study ID
NCT05988632
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 25, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

intranasal adverse events [ Time Frame: From baseline to post-treatment (1 day) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brown UniversityProvidenceRhode Island02903
Zoe Brown
[email protected]
(401) 863-6646
Brian Gully
[email protected]
(401) 863-6646

Find similar trials in Providence, RI

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Brown University· Providence, RI

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