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）：本提案是对RFA-DA-10-016（R01）大麻相关疾病药物开发的回应。与本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）依赖个体戒断（负面影响和由负面影响引起的渴望）症状的影响。本研究的目的是采用安慰剂对照、双盲、随机分配的治疗设计，准确评估TNP在生化证实的MJ戒断15天内对MJ戒断症状的影响。为了实现这些目标，116名经过仔细筛选的大麻依赖者（58名女性）将被随机分配到两种剂量（0毫克或7毫克尼古丁）TNP中的一种，同时他们戒掉MJ 15天。大量的应急资金将用于提供高度的节制和学业完成。这将是第一个充分有力的研究来评估TNP对MJ负面影响相关的戒断症状和使用MJ的冲动的影响。将对两组mj依赖个体的戒断模式和戒断进行评估：1)很少或从不吸烟的个体，以及2)每天吸烟四支或更少的个体（非常轻度的吸烟者）。将采用分层随机化方法控制性别和吸烟状况。假设使用7mg贴片组的MJ戒断症状要比安慰剂组轻。还有一种假设是，高焦虑/神经质和高攻击性/敌意的个体比低这些特征的个体更能从TNP中获益。由于在我们的初步研究中没有观察到性别差异，因此不预测性别差异。如果TNP能被证明有效减轻MJ戒断症状，那么它的非处方可用性、最小的滥用风险和最小的不良副作用将使其成为MJ依赖的理想和高度可实施的治疗方法。有时候简单的解决方案是最好的。