Efficacy of Naltrexone in Women's Smoking Cessation

纳曲酮对女性戒烟的功效

• 批准号: 7232733
• 负责人: ANDREA C KING
• 金额: $ 62.75万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-01 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7232733
• 关键词: Abstinence; Accounting; Affect; Area; Chronic; Cigarette; Clinical Data; Clinical Research; Clinical Trials; Counseling; Data; Effect Modifiers (Epidemiology); Effectiveness; Exhibits; Female; Goals; Health; Intervention; Laboratories; Mediating; Mediator of activation protein; Modeling; Naltrexone; Narcotic Antagonists; Negative Reinforcements; Numbers; Oral; Outcome; Participant; Patients; Pharmacological Treatment; Pharmacotherapy; Physiological; Placebos; Positive Reinforcements; Psychosocial Stress; Public Health; Purpose; Randomized; Randomized Clinical Trials; Rate; Relative (related person); Reporting; Research; Research Personnel; Sampling; Sarin; Sex Characteristics; Smoke; Smoker; Smoking; Smoking Behavior; Smoking Cessation Intervention; Staging; Standards of Weights and Measures; Stress; Sum; Surgeon; System; Taste Perception; Tobacco Use Cessation; Treatment outcome; Week; Weight; Weight Gain; Withdrawal; Withholding Treatment; Woman; Work; attenuation; cigarette smoking; craving; day; disorder later incidence prevention; endogenous opioids; follow-up; improved; male; medication compliance; men; mu opioid receptors; naltrexol; nicotine patch; nicotine replacement; novel; pleasure; programs; response; sex; smoking cessation; trial comparing

DESCRIPTION (provided by applicant): Although women may be particularly susceptible to the damaging effects of chronic cigarette smoking, evidence indicates that they may have more difficulty in maintaining smoking cessation than men. Given women's reduced response to nicotine replacement and other traditional treatments, habitual cigarette smoking, more targeted pharmacotherapy and intervention strategies may be necessary to improve their quit rates. Preliminary data by our group and others indicate that the opioid antagonist naltrexone may be an effective pharmacotherapy approach for female smokers. The purpose of the proposed study is to conduct a randomized clinical trial to compare adjunct treatment with 50 mg oral naltrexone vs. placebo in conjunction with standard smoking cessation treatment with nicotine patch and counseling. Participants (N=324) will be randomized to receive either naltrexone or placebo starting one week prior to the quit date (25 mg for three days; 50 mg thereafter) and continue for 12 weeks after the quit date. The effects of naltrexone will be evaluated during the pre-quit date period, initial smoking cessation, relapse prevention, and at one-year follow-up. It is hypothesized that sex will moderate the effects of naltrexone on outcome, with naltrexone improving prolonged abstinence quit rates in women but not in men. The secondary goal will be to elucidate the mechanisms underlying women's treatment response to naltrexone. Weight (relative weight gain and weight concerns) and smoking-related variables (reduced cigarette pleasure, taste, craving and relief of negative withdrawal affect) may be important factors by which naltrexone improves quit rates in women. Medication compliance, psychosocial stress and levels of naltrexone's metabolite, 6-|3-naltrexol, will also be examined. In sum, the proposed clinical trial will provide a comprehensive study of sex differences in response to adjunct treatment with naltrexone for smoking cessation. Given the public health concerns and significant health consequences of women's continued high rates of smoking, the proposed study may provide important information on a novel treatment strategy targeting the endogenous opioid system to selectively aid in women's smoking cessation.

描述（由申请人提供）： 尽管女性可能特别容易受到长期吸烟的破坏性影响，但有证据表明，她们在维持戒烟方面可能比男性更困难。鉴于女性对尼古丁替代和其他传统治疗的反应减弱，可能需要习惯性吸烟、更有针对性的药物治疗和干预策略来提高她们的戒烟率。我们小组和其他人的初步数据表明，阿片类拮抗剂纳曲酮可能是女性吸烟者的有效药物治疗方法。拟议研究的目的是进行一项随机临床试验，比较 50 毫克口服纳曲酮与安慰剂的辅助治疗以及尼古丁贴片和咨询的标准戒烟治疗。参与者 (N=324) 将被随机分配接受纳曲酮或安慰剂，从戒烟日期前一周开始（三天 25 毫克；此后 50 毫克），并在戒烟日期后继续服用 12 周。纳曲酮的效果将在戒烟前、初次戒烟、预防复吸和一年随访期间进行评估。据推测，性行为会减轻纳曲酮对结果的影响，纳曲酮可以提高女性的长期戒烟率，但不能提高男性的戒烟率。第二个目标是阐明女性对纳曲酮治疗反应的机制。体重（相对体重增加和体重问题）和吸烟相关变量（香烟愉悦感、味道、渴望和负面戒断影响的减轻）可能是纳曲酮提高女性戒烟率的重要因素。药物依从性、社会心理压力和纳曲酮代谢物 6-|3-纳曲醇的水平也将受到检查。总之，拟议的临床试验将提供对纳曲酮辅助戒烟治疗反应的性别差异的全面研究。考虑到公众健康问题以及女性持续高吸烟率对健康的重大影响，拟议的研究可能会提供有关针对内源性阿片类药物系统的新型治疗策略的重要信息，以选择性地帮助女性戒烟。