Smoking Cessation and Smoking Relapse Prevention in Patients with Schizophrenia

精神分裂症患者的戒烟和复吸预防

• 批准号: 7320881
• 负责人: A EDEN EVINS
• 金额: $ 81.23万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-01 至 2011-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7320881
• 关键词: Abstinence; Adverse event; Affect; Age; Air; Antipsychotic Agents; Attention; Biology; Bupropion; Bupropion/Nicotine; Cigarette; Clinical; Cognitive Therapy; Combination Drug Therapy; Control Groups; Coronary heart disease; Dependence; Dose; Double-Blind Method; Effectiveness; Enrollment; Frequencies; Functional disorder; General Population; Genetic Variation; Goals; Hand; Impairment; Intervention; Lung diseases; Malignant Neoplasms; Measurement; Measures; Mediator of activation protein; Memory; Morbidity - disease rate; Neurobehavioral Manifestations; Nicotine; Nicotine Dependence; Nicotine Withdrawal; Nicotinic Agonists; Nicotinic Receptors; Nose; Outcome; Outcome Measure; Participant; Patient Self-Report; Patients; Performance; Personal Satisfaction; Pharmaceutical Preparations; Pharmacotherapy; Phase; Placebo Control; Placebos; Prevalence; Randomized; Rate; Relapse; Reporting; Research Design; Research Personnel; Rewards; Safety; Schizophrenia; Smoke; Smoker; Smoking; Standards of Weights and Measures; Symptoms; Time; Treatment Protocols; Visit; Week; Withdrawal Symptom; Withholding Treatment; base; cigarette smoking; craving; day; design; disorder later incidence prevention; double-blind placebo controlled trial; follow-up; health related quality of life; improved; indexing; mortality; nicotine replacement; prevent; programs; response; smoking cessation; tobacco abstinence

DESCRIPTION (provided by applicant): Between 72% and 90% of schizophrenia patients smoke cigarettes, compared with 24% in the general population. Mortality from coronary disease, pulmonary disease and cancer is 2-6 times higher in schizophrenia patients than age matched controls. Although patients with schizophrenia can be both highly motivated and persistent in attempts to quit smoking, they have had relatively low smoking cessation rates of approximately 20% during treatment and high relapse rates of approximately 75% with standard treatments. We have found that a combined regimen of bupropion and dual nicotine replacement therapies (NRT) is well tolerated and associated with a 52% abstinence rate, a cessation rate comparable to that seen in the general population. While this cessation rate is excellent, 31% of those who were abstinent during treatment relapsed during NRT dose reduction and 77% relapsed by 12 months. Our hypothesis is that decreased nicotinic responsiveness underlies the high rates of relapse to smoking observed in schizophrenia. Because schizophrenia patients have reduced nicotinic responsiveness that is not expected to return to normal after smoking cessation, continuation of a nicotinic agonist may reduce rates of relapse to smoking. Standard treatment for smoking cessation in the general population involves 8-12 weeks of therapy. It is our hypothesis, based on the high rate of relapse to smoking during taper and immediately after discontinuation of pharmacotherapy, and on convincing evidence for a nicotinic receptor dysfunction in schizophrenia, that longer duration of pharmacotherapy is needed to prevent relapse to smoking in patients with schizophrenia. To assess this possibility, we propose to evaluate the safety and efficacy of 12 months of bupropion combined with dual NRT in schizophrenia patients who are able to quit smoking with open treatment. To do so, we will enroll 260 smokers with schizophrenia into an open, 8-week smoking cessation program that includes bupropion, NRT patch, prn NRT nasal spray and group cognitive behavioral therapy. Those who are abstinent at the end of the open intervention (n=91-104) will be randomized to a 44 week, double blind, placebo-controlled trial of bupropion, NRT patch and prn NRT nasal spray at the dose used to quit smoking. Participants will then discontinue study medications and enter a 3-month follow up. The primary outcome measure will be 7-day point prevalence abstinence rate at 12 months in the intervention vs. placebo groups.

描述（由申请人提供）：介于72％至90％的精神分裂症患者抽烟，而普通人群为24％。精神分裂症患者的冠状动脉疾病，肺部疾病和癌症的死亡率高2-6倍。尽管精神分裂症患者在试图戒烟方面既有积极性和持久性，但在治疗期间，他们的吸烟率相对较低，而高复发率约为20％，而高复发率约为75％。我们发现，安非他酮和双尼古丁替代疗法（NRT）的合并方案耐受性良好，并且与52％的禁欲率相关，这是一种与普通人群相当的停止率。虽然这种戒烟率很高，但在NRT剂量降低期间戒酒的患者中有31％，而77％复发了12个月。我们的假设是，烟碱反应降低是精神分裂症中观察到的吸烟的高复发率的基础。由于精神分裂症患者降低了烟碱反应性，预计在戒烟后不会恢复正常，因此烟碱激动剂的延续可能会降低吸烟的复发率。普通人群中戒烟的标准治疗涉及8-12周的治疗。这是我们的假设，基于锥度期间和中断药物治疗后立即对吸烟的复发率，以及令人信服的精神分裂症烟碱受体功能障碍的证据，需要更长的药物治疗持续时间来防止患有精神分裂症患者吸烟的药物疗法。为了评估这种可能性，我们建议评估能够通过开放治疗可以戒烟的精神分裂症患者中12个月安非他酮的安全性和功效。为此，我们将有260名精神分裂症吸烟者进入一个开放的8周戒烟计划，其中包括安非他酮，NRT贴片，PRN NRT NRT鼻喷雾和组认知行为疗法。那些在开放干预结束时戒酒的人（n = 91-104）将被随机分为44周，双盲，安慰剂对照试验的安单行，NRT贴剂和PRN NRT NRT鼻喷雾剂，用于戒烟。然后，参与者将停止研究药物，并输入3个月的随访。在干预措施与安慰剂组的12个月时，主要的结局措施将是7天点的禁欲。