Efficacy of Naltrexone in Women's Smoking Cessation

纳曲酮对女性戒烟的功效

• 批准号: 7118779
• 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/7118779
• 关键词: clinical research; clinical trials; combination therapy; counseling; craving; drug /alcohol abstinence; drug abuse chemotherapy; drug withdrawal; female; gender difference; human subject; human therapy evaluation; longitudinal human study; naltrexone; nicotine replacement; patient oriented research; pleasure; psychological stressor; therapy compliance; weight gain

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）： 虽然妇女可能特别容易受到长期吸烟的损害，但有证据表明，她们可能比男子更难保持戒烟。鉴于女性对尼古丁替代和其他传统治疗的反应降低，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其戒烟率。我们小组和其他人的初步数据表明，阿片类拮抗剂纳洛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 mg口服纳洛酮与安慰剂联合尼古丁贴片和咨询的标准戒烟治疗的辅助治疗。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（25毫克，持续三天;此后50毫克），并在戒烟日期后继续接受12周。纳洛酮的效果将在戒烟前日期期间，初始戒烟，预防复发和一年随访期间进行评估。据推测，性将缓和纳洛酮对结果的影响，纳洛酮改善女性的长期禁欲戒烟率，但不改善男性。第二个目标是阐明妇女对纳洛酮治疗反应的机制。体重（相对体重增加和体重问题）和吸烟相关变量（减少香烟的乐趣，味道，渴望和缓解消极的戒断影响）可能是纳洛酮提高女性戒烟率的重要因素。药物依从性、心理社会压力和纳洛酮代谢物6-|也将检查3-纳洛酮。总之，拟议的临床试验将提供一个全面的研究，性别差异的反应，辅助治疗与纳洛酮戒烟。考虑到公众健康问题和妇女吸烟率持续高企的重大健康后果，拟议的研究可能会提供有关针对内源性阿片系统的新治疗策略的重要信息，以选择性地帮助妇女戒烟。