Nicotine for Marijuana Withdrawal

尼古丁用于大麻戒断

• 批准号: 8146153
• 负责人: DAVID G GILBERT
• 金额: $ 35.28万
• 依托单位: SOUTHERN ILLINOIS UNIVERSITY CARBONDALE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-21 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8146153
• 关键词: Abstinence; Adverse effects; Affect; Aggressive behavior; Anxiety; Applications Grants; Cannabis; Cannabis-Related Disorder; Cigarette; DA10; Development; Dose; Double-Blind Method; Exhibits; Female; Foundations; Future; Gender; Goals; Hostility; Individual; Individual Differences; Laboratories; Light; Marijuana; Marijuana Dependence; Marijuana Smoking; Medical; Methods; Monitor; Moods; Nature; Neurotic Disorders; Nicotine; Pattern; Pharmaceutical Preparations; Pharmacotherapy; Placebo Control; Placebos; Randomized; Relative (related person); Risk; Severities; Sex Characteristics; Smoke; Smoker; Solutions; Symptoms; Testing; Tobacco; Tobacco use; United States; Withdrawal; Withdrawal Symptom; base; cost; craving; efficacy testing; experience; minimal risk; nicotine patch; novel; psychosocial; public health relevance; response; smoking cessation; therapy design; trait

DESCRIPTION (provided by applicant): This proposal is in response to RFA-DA-10-016(R01) Medications Development for Cannabis-Related Disorders. Consistent with the goals of this RFA, the overall goal of the proposed project is to assess the impact of transdermal nicotine patch (TNP) treatment on marijuana (MJ) withdrawal (negative affect and craving motivated by negative affect) symptoms in MJ-dependent individuals. The aim of this proposal is to accurately assess the effects of TNP on MJ withdrawal symptoms across 15 days of biochemically confirmed MJ abstinence using a placebo-controlled, double-blind, randomly assigned treatment design. To achieve these goals, 116 carefully screened cannabis-dependent individuals (58 female) will be randomly assigned to one of two doses (0 mg or 7mg nicotine) of TNP while they abstain from MJ for 15 days. Large financial contingencies will be used to provide a high degree of abstinence and study completion. This will be the first adequately powered study to assess the effects of TNP on MJ negative affect-related withdrawal symptoms and urges to use MJ. Withdrawal patterns and abstinence will be assessed in two groups of MJ-dependent individuals: 1) those who rarely or never smoke tobacco, and 2) those who smoke four or fewer tobacco cigarettes per day (very light tobacco smokers). A stratified randomization method will be used to control for gender and tobacco-smoker status. It is hypothesized that MJ withdrawal symptoms will be less severe in the group assigned to the 7 mg patch than in the group assigned to the placebo. It is also hypothesized that individuals high in anxiety/neuroticism and those high in aggression/hostility will exhibit greater benefits from TNP than those low in these traits. Given that no gender differences were observed in our preliminary study, gender differences are not predicted. The over-the-counter availability, minimal abuse risks, and minimal adverse side-effects associated with TNP would make it an ideal and highly implementable treatment for MJ dependence if it can be demonstrated to be efficacious in reducing MJ withdrawal symptoms. Sometimes simple solutions are the best. PUBLIC HEALTH RELEVANCE: Marijuana dependence increases risks for a variety of psychosocial and medical problems and withdrawal symptoms associated with attempts to quit using marijuana appear to be an important obstacle to quitting for many of the increasing number of marijuana dependent individuals in the United States. Our study would test the important possibility that a pharmacotherapy with a very low abuse potential, transdermal nicotine patch (TNP), is efficacious in reducing marijuana withdrawal symptoms across a 15-day period of abstinence in marijuana-dependent individuals. The rationale for testing the efficacy of TNP in reducing marijuana withdrawal symptoms is based on preliminary evidence from our laboratory suggesting that TNP may be able to reduce these symptoms, as well as evidence from a number of laboratories indicating that marijuana withdrawal symptoms largely parallel those of tobacco withdrawal symptoms both in terms of nature and severity. Our preliminary findings suggest that TNP reduces negative affect and negative affect-motivated urge to use marijuana during abstinence from marijuana in MJ-dependent-users (including those who do not use tobacco). Thus, there is reason to believe that TNP could also assist treatment-seeking marijuana dependent individuals in maintaining marijuana abstinence, whether or not they are tobacco smokers. Sometimes the simplest solutions are the best.

描述（由申请人提供）：该提案是针对RFA-DA-10-016（R01）与大麻相关疾病的药物开发的响应。与该RFA的目标一致，拟议项目的总体目标是评估透皮尼古丁贴片（TNP）治疗对大麻（MJ）戒断（负面影响和渴望受负面影响的负面影响和渴望）症状的影响。该提案的目的是使用安慰剂对照，双盲，随机分配的治疗设计，准确评估TNP对MJ戒断症状的影响。为了实现这些目标，116个精心筛选的大麻依赖性个体（58位女性）将被随机分配给TNP的两种剂量（0 mg或7mg尼古丁）之一，而他们弃用MJ 15天。大型财务意外情况将用于提供高度的禁欲和学习完成。这将是第一项评估TNP对MJ负面影响相关的戒断症状和使用MJ的影响的足够动力的研究。将在两组依赖MJ的个体中评估戒断模式和禁欲：1）那些很少或从不吸烟的人，以及2）每天抽四只或更少的烟草香烟的人（非常轻的烟草吸烟者）。分层的随机化方法将用于控制性别和烟草 - 烟雾者状态。假设分配给7 mg斑块的组中MJ戒断症状的严重程度要比分配给安慰剂的组的严重程度不那么严重。还可以假设，焦虑/神经质和侵略性/敌意高的人比这些性状低的人会从TNP中表现出更大的益处。鉴于我们在我们的初步研究中没有观察到性别差异，因此没有预测性别差异。与TNP相关的非处方供应，最小的滥用风险以及最小的不良副作用将使它成为MJ依赖性的理想且高度可实现的治疗方法，如果可以证明它可以有效地减少MJ戒断症状。有时简单的解决方案是最好的。 公共卫生相关性：大麻依赖性增加了各种心理社会和医疗问题的风险，以及与尝试使用大麻的戒烟相关的戒断症状似乎是戒烟的重要障碍。我们的研究将测试重要的可能性，即具有非常低滥用潜力的药物疗法，透皮尼古丁贴片（TNP）在减轻大麻依赖性人的15天戒酒期内减少大麻戒断症状有效。测试TNP减少大麻戒断症状功效的基本原理是基于我们实验室的初步证据，表明TNP可能能够减少这些症状，以及许多实验室的证据，表明大麻戒断症状在很大程度上与烟草戒断症状相似，而烟草戒断症状的性质和严重程度都相似。我们的初步发现表明，TNP减少了在MJ依赖性用户中禁止大麻戒酒期间使用大麻的负面影响和负面影响动机的冲动（包括那些不使用烟草的人）。因此，有理由相信TNP也可以协助寻求治疗的大麻依赖人维持大麻戒酒，无论他们是否是吸烟者。有时最简单的解决方案是最好的。