Clinical trial NCT05988632: Intranasal Insulin for Treatment of Alcohol Use Disorder
Official title: Intranasal Insulin for Treatment of Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Alcohol Use Disorder
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

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)

Primary outcomes:
measure: intranasal adverse events
timeFrame: From baseline to post-treatment (1 day)
Secondary outcomes:
measure: insulin alcohol interaction
timeFrame: From baseline to post-treatment (1 day)
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
References: