RECRUITING

Intranasal Insulin for Treatment of Alcohol Use Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Intranasal Insulin for Treatment of Alcohol Use Disorder

Quick Facts

Study Start:2024-03-25
Study Completion:2025-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05988632

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥21 years
  2. * meet any DSM-5 criteria score for AUD
  3. * 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)
  4. * BrAC=0.00g/dL at each visit
  5. * good health as confirmed by medical history, physical examination and lab tests
  6. * willing to adhere to the study procedures
  7. * understand informed consent and questionnaires in English at an 8th grade level
  8. * willing to have glucose monitored by finger stick during the laboratory procedures
  1. * • female identifying who are breastfeeding or pregnant (assessed by a urine screen)
  2. * individuals with diabetes
  3. * history of suicide attempts in the last three years
  4. * current diagnosis of other substance use disorder (other than nicotine or cannabis)
  5. * use of drugs (e.g. stimulants/opioids) at each alcohol administration session (by urine tox screen)
  6. * cannabis intoxication (by clinical assessments)
  7. * use of medications that may interact with insulin and alcohol (by Micromedex database)
  8. * hypersensitivity to insulin
  9. * any nasal disease/congestion that may interfere with intranasal drug absorption;
  10. * baseline hypoglycemia (blood glucose ≤65mg/dL) or hyperglycemia (blood glucose \>200mg/dL) (by finger stick)

Contacts and Locations

Study Contact

Carolina L Haass-Koffler
CONTACT
4155191385
carolina_haass-koffler@brown.edu

Study Locations (Sites)

Brown University
Providence, Rhode Island, 02903
United States

Collaborators and Investigators

Sponsor: Brown University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-25
Study Completion Date2025-03-30

Study Record Updates

Study Start Date2024-03-25
Study Completion Date2025-03-30

Terms related to this study

Additional Relevant MeSH Terms

  • Alcohol Use Disorder