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Mirtazapine for methamphetamine use disorder: drug-drug interaction study

米氮平治疗甲基苯丙胺使用障碍：药物相互作用研究

基本信息

批准号：
9983371
负责人：
PHILLIP O COFFIN
金额：
$ 220.56万
依托单位：
PUBLIC HEALTH FOUNDATION ENTERPRISES
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-06-01 至 2022-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9983371
关键词：
Abstinence Achievement Address Adherence Admission activity Adrenergic Agents Adult Adverse event Agonist Amphetamines Behavior Therapy Blood Pressure Bupropion Cardiac Cardiovascular system Cessation of life Clinical Trials Unit Cross-Over Studies Crossover Design Data Decision Making Development Disease Dose Double-Blind Method Double-blind trial Drug Interactions Drug Kinetics Enrollment Ensure Evaluation FDA approved General Population HIV HIV risk Heart Rate Heroin Hour Human Impulsivity Infusion procedures Inpatients Institution Intervention Laboratories Los Angeles Medicine Mental Depression Methadone Methamphetamine Mirtazapine Monitor Morbidity - disease rate Morphine Naltrexone Opioid Oral Outpatients Participant Patients Persons Pharmaceutical Preparations Pharmacological Treatment Pharmacology Pharmacotherapy Phase Phase II Clinical Trials Placebos Poisoning Process Psychological Tests Randomized Research Risk Behaviors Running Safety Sample Size San Francisco Serotonin Serotonin Syndrome Signs and Symptoms Site Speed Study Subject Subgroup Testing Toxicology United States Urine Visit addiction aripiprazole arm base comorbidity craving depressive symptoms economic cost follow-up heart rhythm illicit opioid inpatient service male medication safety men men who have sex with men methadone treatment methamphetamine effect methamphetamine use methamphetamine user morphine administration mortality opioid epidemic opioid use opioid use disorder phase I trial phase III trial prescription opioid psychologic psychostimulant response screening sex sleep quality transgender women transmission process treatment arm

项目摘要

Project Summary/Abstract Methamphetamine use is a major driver of drug-related morbidity and mortality, with intimate involvement in the national opioid crisis as well. Methamphetamine is more prevalent than many other drugs, including opioids, with 37 million users of methamphetamine and amphetamine worldwide and 1.4 million past-year users in the U.S. alone in 2016. The annual economic cost of methamphetamine use is estimated to be $23.4 billion in the United States. There are no FDA-approved pharmacotherapies for methamphetamine use disorder, a major gap in the field of addition medicine. Promising agents such as bupropion, extended-release naltrexone, aripiprazole, and selected amphetamine-based stimulants, have all shown mixed or negative results in phase 2 clinical trials. In contrast, in two separate phase 2 clinical trials mirtazapine has demonstrated a significant effect in increasing periods of abstinence from methamphetamine and decreasing related HIV risk behaviors among adults with methamphetamine use disorder who were born male and have sex with men. While testing this product in the general population, with larger samples sizes, and more intensive adherence interventions is demanded, the first step required by the FDA is now a drug-drug interaction study to evaluate pharmacokinetics of methamphetamine in the presence of mirtazapine, to evaluate for adverse events such as QT prolongation and serotonin syndrome, and to ensure the safety of these combinations in patients with co-morbid opioid use disorder who may be using illicit opioids or maintained on agonist therapy. We propose to conduct this Phase 1 human laboratory trial, also exploring mechanisms for the effect of mirtazapine with a battery of psychological testing, with 36 subjects (Group 1 with no opioid use, Group 2 with illicit opioid use, Group 3 with opioid use disorder maintained on methadone) in a within-subject crossover study. After screening, participants will be admitted to a 16-day inpatient stay, randomly assigned to mirtazapine or placebo, followed to steady state, and given placebo and a methamphetamine infusion with associated batteries of psychological testing; they will then be followed for 5 days for washout and initiated in the opposite treatment arm. Results will contribute toward further evaluation of mirtazapine for treatment of methamphetamine use disorder.

项目总结/文摘