A COMPREHENSIVE SMOKING CESSATION CLINICAL TRIAL

全面戒烟临床试验

• 批准号: 7604784
• 负责人: ANDREA C KING
• 金额: $ 2.75万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604784
• 关键词: Abstinence; Affect; Chronic; Cigarette; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Counseling; Funding; Goals; Grant; Institution; Intervention; Naltrexone; Oral; Outcome; Participant; Pharmacotherapy; Placebos; Psychosocial Stress; Purpose; Randomized; Randomized Clinical Trials; Rate; Relative (related person); Research; Research Personnel; Resources; Sex Characteristics; Smoke; Source; Standards of Weights and Measures; Sum; Taste Perception; United States National Institutes of Health; Week; Weight; Weight Gain; Withdrawal; Withholding Treatment; Woman; cigarette smoking; craving; disorder later incidence prevention; follow-up; improved; medication compliance; men; naltrexol; nicotine patch; nicotine replacement; pleasure; response; sex; smoking cessation

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. 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, more targeted pharmacotherapy and intervention strategies may be necessary to improve their quit rates. 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 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 mechanism 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-B-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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 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的反应降低，可能需要更有针对性的药物治疗和干预策略来提高她们的戒烟率。 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）将随机接受纳洛酮或安慰剂，从戒烟日期前一周开始，并在戒烟日期后持续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。还将检查药物依从性、心理社会压力和纳洛酮代谢物6-B-纳洛酮的水平。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。