Intermittent Naltrexone among Polysubstance Users

多物质使用者间歇性使用纳曲酮

• 批准号: 8467609
• 负责人: Glenn-Milo Santos
• 金额: $ 5.64万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-30 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8467609
• 关键词: AIDS prevention; Adult; Adverse event; Alcohol dependence; Alcohol or Other Drugs use; Alcohols; Amphetamines; Attenuated; Back; Behavior assessment; Binomial Model; Blood Circulation; Clinical; Counseling; Dancing; Data; Dose; Double-Blind Method; Drug usage; Enrollment; Epidemic; Evaluation; Event; Exposure to; FDA approved; Frequencies; Future; HIV; HIV Infections; HIV Seropositivity; Heavy Drinking; High Prevalence; Individual; Infection; Intervention; Interview; Link; Logistic Models; Methamphetamine; Monitor; Morbidity - disease rate; Naltrexone; Opioid Receptor; Oral; Outcome; Participant; Patient Self-Report; Patients; Pattern; Pharmaceutical Preparations; Pilot Projects; Placebos; Population; Preparation; Prevention Research; Prevention strategy; Prophylactic treatment; Randomized; Regimen; Relapse; Risk; Risk Behaviors; Risk Reduction; Safety; Schedule; Services; Sex Behavior; Social Interaction; Structure; Surveys; Text; Time; TimeLine; Toxic effect; United States; Unsafe Sex; Visit; arm; base; binge drinking; craving; design; double-blind placebo controlled trial; drinking; drinking behavior; economic cost; effective intervention; efficacy trial; forgetting; high risk; innovation; interest; medication compliance; men; men who have sex with men; mortality; neglect; pill; sex risk; systematic review; treatment effect

DESCRIPTION (provided by applicant): Methamphetamine (meth) use and binge drinking (defined for men as drinking five or more drinks on one occasion) are associated with significant morbidity and mortality. The economic cost of meth use and binge drinking in the US exceeds $23 and $170 billion, respectively. Among MSM, meth use and binge drinking are up to 20 and 3.5 times more prevalent than in the general U.S. adult population, respectively. Moreover, these two substances are consistently associated with unprotected sex and HIV seroconversion among MSM, who comprise over half of the new infections in the U.S. Thus, effective interventions to reduce meth use and binge drinking may also function as an important HIV prevention strategy by reducing substance-related HIV risk behavior. Naltrexone, a u-opioid receptor antagonist, is a promising agent for meth-using and binge-drinking MSM. Naltrexone has shown efficacy in reducing relapse to amphetamines and is FDA-approved for alcohol dependence. Oral naltrexone is inexpensive and has few toxicities but the standard daily regimen for naltrexone is problematic as patients forget to take the medication. Given the challenges in daily dosing, alternate regimen schedules have been proposed to increase efficacy and expand the population that may benefit. One approach is intermittent targeted administration of naltrexone, whereby individuals take the medication as needed in anticipation of substance use or during periods of craving. Administration of naltrexone prior to exposure to amphetamines significantly attenuates craving and targeted naltrexone has shown efficacy in reducing heavy alcohol use. However, there have been no studies assessing intermittent targeted dosing of naltrexone among meth-using and binge-drinking MSM. Polysubstance use patterns are common among MSM-studies among those who take more than one substance are urgently needed. The aims of this study are to determine whether targeted dosing of naltrexone is feasible, tolerable and acceptable among non-dependent meth-using and binge-drinking MSM. Design: This is a pilot, double-blind, placebo-controlled trial of targeted oral naltrexone. Thirty non-dependent, episodic meth-using and binge-drinking MSM will be randomly assigned to receive 8 weeks of naltrexone 50 mg or placebo, to be taken on an as-needed basis to attenuate meth craving or reduce binge drinking. Participants will be seen bi-weekly to receive study drug and substance use counseling. Safety assessments and behavioral surveys will be completed at bi-weekly and monthly visits. Feasibility, tolerability, and acceptability (Specific Aims 1-3) will be assessed with enrollment and retention rates, frequency of adverse events, participant evaluation of targeted dosing and medication adherence. Meth use and drinking outcomes will be assessed via daily text messages and bi-weekly timeline follow-back (Exploratory Aims). Sexual behaviors will be assessed via monthly surveys (Exploratory Aims). GEE logistic models will be used compare the proportions of MSM taking medication during periods of meth craving and binge drinking. GEE binomial and negative binomial models will be used to assess treatment effects on meth use, drinking and sexual behavior. PUBLIC HEALTH RELEVANCE: Meth use and binge drinking are linked to HIV-related sexual risk behaviors and HIV infection among men who have sex with men (MSM). This study will examine the feasibility, tolerability and acceptability of taking naltrexone on an as-needed basis during periods of meth craving and in anticipation of drinking among MSM. This study will contribute to the field of substance use and HIV prevention research for a marginalized and disproportionately impacted population.

描述（由申请人提供）：使用甲基苯丙胺（meth）和酗酒（对男性的定义是一次喝五杯或更多酒）与显着的发病率和死亡率相关。在美国，吸食冰毒和酗酒造成的经济损失分别超过 23 美元和 1700 亿美元。在 MSM 中，吸食冰毒和酗酒的比例分别是美国普通成年人口的 20 倍和 3.5 倍。此外，这两种物质始终与 MSM 中的无保护​​性行为和 HIV 血清转化有关，而 MSM 占美国新增感染病例的一半以上。因此，减少冰毒使用和酗酒的有效干预措施也可能成为一项重要的 HIV 预防策略，通过减少与物质相关的艾滋病毒危险行为。纳曲酮是一种 u-阿片受体拮抗剂，对于吸食冰毒和酗酒的 MSM 来说是一种很有前景的药物。纳曲酮已显示出可减少安非他明复发的功效，并已获得 FDA 批准用于治疗酒精依赖。口服纳曲酮价格便宜且毒性很小，但纳曲酮的标准每日治疗方案存在问题，因为患者忘记服药。鉴于每日给药的挑战，已提出替代方案以提高疗效并扩大可能受益的人群。一种方法是间歇性有针对性地给予纳曲酮，个人在预期会使用药物或在渴望药物期间根据需要服用药物。在接触安非他明之前服用纳曲酮可显着减弱对酒精的渴望，并且靶向纳曲酮已显示出减少酗酒的功效。然而，目前还没有研究评估吸食冰毒和酗酒的 MSM 之间间歇性靶向给药纳曲酮的情况。多物质使用模式在 MSM 研究中很常见，这些研究中那些迫切需要服用一种以上物质的人。本研究的目的是确定纳曲酮的靶向给药对于非依赖冰毒使用和酗酒的 MSM 是否可行、可耐受和可接受。设计：这是一项针对靶向口服纳曲酮的双盲、安慰剂对照试验。 30 名非依赖性、间歇性吸食冰毒和酗酒的 MSM 将被随机分配接受 8 周 50 毫克纳曲酮或安慰剂，根据需要服用，以减轻对冰毒的渴望或减少酗酒。参与者将每两周接受一次研究药物和物质使用咨询。安全评估和行为调查将在每两周和每月一次的访问中完成。可行性、耐受性和可接受性（具体目标 1-3）将通过入组率和保留率、不良事件发生频率、参与者对目标剂量的评估和药物依从性进行评估。冰毒使用和饮酒结果将通过每日短信和每两周一次的时间表跟进进行评估（探索性目标）。性行为将通过每月调查（探索性目标）进行评估。 GEE 逻辑模型将用于比较 MSM 在冰毒成瘾和酗酒期间服用药物的比例。 GEE 二项式和负二项式模型将用于评估对冰毒使用、饮酒和性行为的治疗效果。 公共卫生相关性：使用冰毒和酗酒与男男性行为者 (MSM) 中与艾滋病毒相关的性危险行为和艾滋病毒感染有关。本研究将探讨 MSM 在冰毒渴望期间和预期饮酒期间按需服用纳曲酮的可行性、耐受性和可接受性。这项研究将为边缘化和受影响不成比例的人群的物质使用和艾滋病毒预防研究领域做出贡献。