Intranasal Insulin for Treatment of Alcohol Use Disorder

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• intranasal adverse events [Срок оценки: From baseline to post-treatment (1 day)]

Вторичные конечные точки (1)

• insulin alcohol interaction [Срок оценки: From baseline to post-treatment (1 day)]

Критерии участия

Критерии включения

• ≥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

Критерии исключения

• • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Brown University — Providence

Публикации

• Haass-Koffler CL, Kashyap B, Gully BJ, Nambiar SS, Hornbacher R, Foster SL, Silberman Y, Swift RM, Hanson LR, Frey WH 2nd. Intranasal insulin for the treatment of alcohol use disorder: design and methodology of an alcohol interaction randomized controlled trial. Contemp Clin Trials Commun. 2025 Jun 10;46:101509. doi: 10.1016/j.conctc.2025.101509. eCollection 2025 Aug. PMID 40584152

Идентификаторы

NCT: NCT05988632 · STUDY00000134

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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