Intranasal Insulin for Treatment of Alcohol Use Disorder
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- intranasal adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •• 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)
研究组 & 干预措施
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.
干预措施: Regular Human Insulin then Placebo (Drug)
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.
干预措施: Placebo then Regular Human Insulin (Drug)
结局指标
主要结局
intranasal adverse events
时间窗: From baseline to post-treatment (1 day)
Adverse event reported during the drug administration
次要结局
- insulin alcohol interaction(From baseline to post-treatment (1 day))
研究者
Carolina L Haass-Koffler
Associate Professor
Brown University