美沙酮维持治疗的吸烟者中，直接观察治疗与自行应用伐伦克林治疗对伐伦克林依从性和戒烟的影响：一项随机对照试验。
Effect of varenicline directly observed therapy versus varenicline self-administered therapy on varenicline adherence and smoking cessation in methadone-maintained smokers: a randomized controlled trial.
机构信息
Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA.
Department of Psychiatry and Behavioral Sciences, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA.
出版信息
Addiction. 2021 Apr;116(4):902-913. doi: 10.1111/add.15240. Epub 2020 Oct 13.
BACKGROUND AND AIMS
Level of adherence to tobacco cessation medication regimens is believed to be causally related to medication effectiveness. This study aimed to evaluate the efficacy of varenicline directly observed therapy (DOT) on varenicline adherence and smoking cessation rates among smokers with opioid use disorder (OUD) receiving methadone treatment.
DESIGN
Multicenter, parallel-group two-arm randomized controlled trial.
SETTING
Urban opioid treatment program (OTP) in the Bronx, New York, USA.
PARTICIPANTS
Daily smokers of ≥ 5 cigarettes/day, interested in quitting (ladder of change score 6-8), in methadone treatment for ≥ 3 months, attending OTP ≥ 3 days/week. Participants' mean age was 49 years, 56% were male, 44% Latino, 30% Black, and they smoked a median of 10 cigarettes/day.
INTERVENTIONS
Individual, block, random assignment to 12 weeks of varenicline, either directly observed with methadone (DOT, n = 50) or via unsupervised self-administered treatment (SAT, n = 50).
MEASUREMENTS
The primary outcome was adherence measured by pill count. The secondary outcome was 7-day point prevalence tobacco abstinence verified by expired carbon monoxide (CO) < 8 parts per million.
FINDINGS
Retention at 24 weeks was 92%. Mean adherence was 78.5% [95% confidence interval (CI) = 71.8-85.2%] in the DOT group versus 61.8% in the SAT group (95% CI = 55.0-68.6%); differences were driven by DOT effects in the first 6 weeks. CO-verified abstinence did not differ between groups during the intervention (P = 0.26), but was higher in the DOT than the SAT group at intervention end (DOT = 18% versus SAT = 10%, difference = 8%, 95% CI = -13, 28); this difference was not significant (P = 0.39) and was not sustained at 24-week follow-up.
CONCLUSIONS
Among daily smokers attending opioid treatment programs, opioid treatment program-based varenicline directly observed therapy was associated with early increases in varenicline adherence compared with self-administered treatment, but findings were inconclusive as to whether directly observed therapy was associated with a difference in tobacco abstinence.
背景与目的
据信，戒烟药物治疗方案的依从性与药物疗效有关。本研究旨在评估在接受美沙酮治疗的阿片类药物使用障碍（OUD）吸烟者中，使用维拉唑胺直接观察治疗（DOT）对维拉唑胺依从性和戒烟率的影响。
设计
多中心、平行组双臂随机对照试验。
地点
美国纽约布朗克斯的城市阿片类药物治疗计划（OTP）。
参与者
每天吸烟≥5 支/天，有戒烟意愿（阶梯变化评分 6-8），正在接受美沙酮治疗≥3 个月，每周至少参加 OTP≥3 天。参与者的平均年龄为 49 岁，56%为男性，44%为拉丁裔，30%为黑人，平均每天吸烟 10 支。
干预措施
个体、分组、随机分配 12 周的维拉唑胺，分别接受美沙酮直接观察（DOT，n=50）或非监督自我管理治疗（SAT，n=50）。
测量
主要结局是通过药片计数测量的依从性。次要结局是通过呼出的一氧化碳（CO）<8ppm 验证的 7 天点患病率烟草戒断。
结果
24 周时的保留率为 92%。DOT 组的平均依从率为 78.5%（95%CI=71.8-85.2%），而 SAT 组为 61.8%（95%CI=55.0-68.6%）；差异是由 DOT 在最初 6 周的影响造成的。在干预期间，两组间 CO 验证的戒烟率没有差异（P=0.26），但在干预结束时，DOT 组高于 SAT 组（DOT=18%，SAT=10%，差异=8%，95%CI=-13，28）；差异无统计学意义（P=0.39），在 24 周随访时未持续存在。
结论
在接受阿片类药物治疗的吸烟者中，与自我管理治疗相比，基于阿片类药物治疗计划的维拉唑胺直接观察治疗与维拉唑胺依从性的早期增加有关，但尚不能确定直接观察治疗是否与戒烟率的差异有关。
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