Improving Treatment Outcomes for Prescription Opioid Dependence

改善处方阿片类药物依赖的治疗结果

• 批准号: 9104113
• 负责人: MICHAEL J MANCINO
• 金额: $ 57.29万
• 依托单位: UNIV OF ARKANSAS FOR MED SCIS
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-15 至 2020-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9104113
• 关键词: Address; Adolescent and Young Adult; Adrenergic Agonists; Agonist; Buprenorphine; Calcium Channel Blockers; Cessation of life; Chronic; Consumption; Controlled Clinical Trials; Data; Dependence; Development; Disease; Drug Interactions; Drug Metabolic Detoxication; FDA approved; Goals; Health; Heroin; Human; Individual; Interview; Maintenance; Mediator of activation protein; Methadone; Methods; Modeling; Morphine; Movement; N-Type Calcium Channels; Naltrexone; Narcotic Antagonists; Opiate Addiction; Opioid; Opioid Analgesics; Outcome; Outpatients; Overdose; Pain; Participant; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Physiological; Placebo Control; Placebos; Population; Postoperative Period; Procedures; Public Health; Randomized; Regimen; Relapse; Rural Community; Safety; Symptoms; Time; Treatment outcome; Withdrawal; Withdrawal Symptom; Work; addiction; clinical practice; craving; follow-up; gabapentin; high risk behavior; illicit drug use; improved; improved outcome; innovation; novel; opioid use; opioid withdrawal; prescription opioid; prescription opioid abuse; programs; reverse tolerance; secondary outcome; social stigma; symptomatology; tool; treatment strategy

 DESCRIPTION (provided by applicant): Opioid dependence is a serious public health problem, particularly with the dramatic rise in prescription opioid (PO) abuse, but long-term opioid agonist maintenance with methadone or buprenorphine (BUP) may not be optimal for many PO abusers. Yet current opioid detoxification strategies are limited by high relapse rates and/or lack of efficacy in relieving subjective symptoms. In addition, antagonist maintenance with naltrexone (NTX), which may be an optimal longer-term strategy for this population, requires prior opioid detoxification and has been associated with relatively poor outcomes in heroin abusers. This application takes a novel, broad approach to address the problem of PO dependence by determining the 1) utility of adjunct gabapentin (GBP) during outpatient BUP detoxification to improve initial outcomes and 2) feasibility of transitioning PO-dependent patients to depot NTX following detoxification, which may improve longer-term outcomes. GBP, an N-type calcium channel blocker with low abuse potential, potentiates opioid analgesia, decreases both postoperative morphine consumption and movement-related pain, and reverses tolerance to the antinociceptive effects of morphine. GBP is also well tolerated and effective in reducing craving and illicit opioid use in pilot detoxification trials. We propose to assess the efficacy and tolerability of adjunct GBP during BUP-assisted detoxification and the feasibility of subsequent transition to depot NTX therapy in PO-dependent participants. This 8-week, randomized, placebo-controlled clinical trial will determine the potential utility of adjunct GBP i 150 PO- dependent individuals undergoing outpatient BUP detoxification and whether transition to short-term depot NTX therapy is feasible. Our three specific aims are to determine (1) the efficacy and tolerability of GBP to reduce craving and illicit use of opioids in PO-dependent individuals undergoing outpatient BUP detoxification; (2) acceptability and feasibility of transitin to, and short-term maintenance on, depot NTX following detoxification; and (3) prognosticators of completion of the BUP taper, successful induction onto depot NTX, symptomatology, and longer-term outcomes. Currently, the only FDA-approved medications for the treatment of opioid withdrawal are the opioid agonists methadone and BUP, both of which have abuse liability, and NTX, which can produce low levels of withdrawal-like symptoms, especially early in treatment. Our findings, if positive, will support further development of GBP as an adjunct medication as well as provide an integrated, seamless approach to outpatient PO-dependence treatment. Ultimately, this work could impact the addiction field by providing both procedural and pharmacological tools for treating PO dependence that significantly improve outpatient detoxification outcomes and markedly enhance access and transition to NTX therapy. This would shift clinical practice, establishing an effective adjunct regimen for BUP detoxification and an integrated approach f or transition to NTX therapy. GBP may also be clinically useful for other situations where opioid withdrawal is a concern.

 描述（申请人证明）：阿片类药物依赖是一个严重的公共卫生问题，尤其是在处方滥用的情况下，但长期使用美沙酮或丁丙诺啡（BUP）的阿片类药物维护虐待者，目前的阿片类药物排毒策略受到高复发率的限制和/或缺乏缓解症状，纳尔特雷酮（NTX）的拮抗剂维持（NTX）可能是该人群的最佳长期策略与海洛因滥用者相对结果相关。低低低低低低较低储物柜镇痛d疼痛的低低低低低较低低较低的镇痛药，而在辅助GBP期间，对e的抗性？随后的8周，随机，安慰剂对照的三联体向depot ntx治疗的过渡能力将确定他的潜在辅助GBP I 150个po依赖性的个人OUTPATIENG OUTPATIENG OUTPATIENG OUTPATIENG OUTPATITIENG OUTPATITIENG OUTPATITIEN术语NTX治疗是我们的三个特异性。 - 阿片类药物戒断的药物是美沙酮和bup症状的症状，尤其是在治疗的早期（如果阳性）中在治疗PO依赖性的过程和药理学工具下，成瘾的依赖性显着改善了室内化的结果，并显着增强了对NTX治疗的访问和过渡。 综合方法或过渡到NTX疗法。