Tiagabine for Cocaine Dependence in Methadone Treatment

噻加宾治疗美沙酮治疗中的可卡因依赖

• 批准号: 7228946
• 负责人: Gerardo Gonzalez
• 金额: $ 30.52万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-15 至 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7228946
• 关键词: 4-Aminobutyrate aminotransferase; Abstinence; Age; Animals; Anxiety; Attenuated; Baclofen; Behavior; Behavior Therapy; Clinical Trials; Cocaine; Cocaine Abuse; Cocaine Dependence; Cognitive Therapy; Consumption; Data; Dopamine; Dose; Double-Blind Method; GABA transporter; GABA-B Receptor; HIV; Hepatitis C; Heroin; Hour; Individual; Institution; Intervention; Label; Methadone; Numbers; Opiate Addiction; Opiates; Opioid; Outcome; Participant; Patient Self-Report; Patients; Personal Satisfaction; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Pilot Projects; Placebo Control; Placebos; Population; Positioning Attribute; Psychotherapy; Randomized; Randomized Clinical Trials; Rate; Relapse; Relative (related person); Reporting; Research; Risk; Role; Safety; Serotonin; Substance abuse problem; Supervision; Symptoms; System; Testing; Training; Treatment Efficacy; Treatment outcome; Urinalysis; Vigabatrin; Week; Withdrawal Symptom; Work; base; day; design; experience; follow-up; gabapentin; gamma-Aminobutyric Acid; inhibitor/antagonist; neurotransmission; preclinical study; psychosocial; reuptake; tiagabine; treatment duration; uptake

DESCRIPTION (provided by applicant): No effective pharmacological treatment for cocaine dependence has yet been developed. Comorbid cocaine dependence among methadone maintained patients interferes with treatment outcomes, and increases the risk of relapse to IV use, which is associated with increased risk for HIV and Hepatitis C. Enhanced GABA eurotransmission appears to attenuate cocaine's reinforcing effects. The objective of this proposal is to examine to what extend will enhancing the GABA system modify cocaine-using behavior and attenuate opiate withdrawal symptoms among newly admitted methadone treated patients. The primary hypothesis is that enhancing the GABA system with a GABA transporter blocker tiagabine we expect to reduce cocaine use and to promote abstinence in cocaine abusing methadone treated patients. The secondary hypothesis is that enhancing the GABA system with a GABA transporter blocker tiagabine we expect to attenuate early opiate withdrawal symptoms in newly admitted methadone treated patients. These hypotheses are formulated based on our pilot studies using the selective GABA re-uptake inhibitor tiagabine. This 14-week double-blind, placebo controlled randomized clinical trial will provide treatment for 120 cocaine and opioid dependent patients. Participants, aged 18-65 years, will be randomized to receive tiagabine 32mg/day, tiagabine 20mg/day or placebo while concurrently receiving treatment with methadone. All participants receive weekly 1-hour individual psychotherapy (Cognitive Behavioral Therapy) with experienced clinicians specifically trained to deliver the therapy and who will receive ongoing supervision. A follow-up at 3 months will allow us to evaluate opioid and cocaine use, and changes in psychosocial adjustment. The primary outcomes will be abstinence rates and reduction in opioid and cocaine use, as assessed by self-report and thrice-weekly urinalyses. The proposed study is expected to provide a better understanding of the role of the selective GABA re-uptake inhibitor tiagabine on cocaine using behavior and treatment of opiate withdrawal symptoms, and will provide valuable information to develop new pharmacological interventions for comorbid cocaine dependence among methadone treated patients.

描述（由申请人提供）：没有有效的药物治疗可卡因依赖尚未开发。维持美沙酮的患者的合并症可卡因依赖会干扰治疗结果，并增加静脉注射的复发风险，这与艾滋病毒和丙型肝炎的风险增加有关。增强的GABA神经传播似乎减弱了可卡因的强化作用。本研究旨在探讨GABA系统的增强对新入院美沙酮治疗患者的可卡因使用行为和阿片戒断症状的影响。主要的假设是，使用GABA转运体阻滞剂替加滨增强GABA系统，我们期望减少可卡因的使用，并促进可卡因滥用美沙酮治疗患者的戒断。第二个假设是，使用GABA转运体阻滞剂替加滨增强GABA系统，我们期望减轻新入院美沙酮治疗患者的早期阿片类戒断症状。这些假设是基于我们使用选择性GABA再摄取抑制剂替加滨的初步研究而制定的。