Medication Development for Opioid and Alcohol Abuse: Laboratory Study in Humans

New York State Psychiatric Institute1 个研究点分布在 1 个国家目标入组 17 人开始时间: 2017年8月1日最近更新: 2022年10月6日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: New York State Psychiatric Institute
入组人数: 17
试验地点: 1
主要终点: Peak Positive Subjective Responses to Placebo.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The present proposal will evaluate the ability of gabapentin maintenance to reduce the abuse liability of alcohol, oxycodone, and alcohol in combination with oxycodone in participants with both Opioid Use Disorder and Alcohol Use Disorder.

详细描述

Currently, the abuse of prescription opioid medications is a pervasive problem in the U.S. In addition, co-abuse of opioids and alcohol represents a significant problem from the perspective of increased toxicity and decreased success in treatment. Surprisingly few studies have examined the effects of combined administration of opioids and alcohol in humans, and no clinical studies have examined the reinforcing effects of this combination. The current 8-9-week inpatient study will systematically evaluate gabapentin because it shows promise for treating both opioid and alcohol use disorders (OUD and AUD). The guiding principle is that a medication's effects on positive subjective responses and reinforcing effects are the best laboratory procedures to date in predicting its clinical efficacy. We will examine the ability of gabapentin (0 mg or 1800 mg) to alter opioid-, alcohol-,and combined opioid/alcohol-mediated responses. Participants will meet DSM-5 criteria for moderate-severe OUD and be physically dependent on opioids. In addition, participants will meet DSM-5 criteria for moderate-severe AUD, but they will not be physically dependent on alcohol. All of the participants will be maintained on oral morphine throughout the study and different doses of gabapentin will be evaluated.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Basic Science
盲法: Double (Participant, Outcomes Assessor)

入排标准

年龄范围: 21 Years 至 59 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•DSM-5 criteria for moderate-severe opioid use disorder with physical dependence.
•DSM-5 criteria for moderate-severe alcohol use disorder without physical dependence.
•No current major mood, psychotic, or anxiety disorder.
•Physically healthy.
•Able to perform study procedures.
•21-59 years of age.
•Normal body weight/Within 20% of body weight (for appropriate frame) according to 1983 Metropolitan Weight tables.
•Current or history of illicit opioid use.
•Current use of opioids in amounts and/or frequencies that meet or exceed those used in the proposed study (e.g., 3-4 tablets of a Rx opioid medication per day or 1-2 bags of heroin per day). Not seeking treatment for opioid use disorder (neutral attitude or not wanting treatment only).
•Participants will consume alcohol at least 3 times per week (15 drinks per week for men and 8 drinks per week for women). In addition, they will drink alcohol and use opioids simultaneously.

排除标准

•DSM-5 criteria for substance use disorder (moderate to severe) on drugs other than opioids, alcohol, nicotine or caffeine (must be less than 500 mg caffeine daily).
•Participants requesting treatment.
•Pregnancy or lactation.
•Current or recent history of significant violent or suicidal behavior and/or suicidal/homicidal risk.
•Cannot read or understand the self-report assessment forms unaided, or are so severely disabled that they cannot comply with the requirements of the study.
•Elevated liver function tests (i.e., AST and ALT > 3 times the upper limit of normal) or impaired renal function (creatinine must be within normal limits).
•Physical disorders that might make participation hazardous such as AIDS, cancer, hypertension (blood pressure > 140/90), uncontrolled diabetes, pulmonary hypertension or heart disease (please note that participants will be asked about previous visits to a cardiologist, chest pain, or strong palpitations; if these exist, they will be referred to a cardiologist and excluded unless cleared for participation by a cardiologist).
•Current major Axis I psychopathology, other than OUD and AUD (e.g., mood disorder with functional impairment, schizophrenia), that might interfere with ability to participate in the study.
•Sensitivity, allergy, or contraindication to opioids, alcohol, gabapentin or similar medications.
•Taken an investigational drug within the past 30 days.
•Current or history of chronic pain within the past 3 months.
•Taking prescription psychotropic medications that would potentially interfere with study procedures.

研究组 & 干预措施

Gabapentin 0 mg

Placebo Comparator

once daily at 8am

干预措施: Gabapentin (Drug)

Gabapentin 1800 mg

Active Comparator

once daily at 8am

干预措施: Gabapentin (Drug)

结局指标

主要结局

Peak Positive Subjective Responses to Placebo.

时间窗: Assessed every 15 minutes following drug administration,for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.