胱氨酸与尼古丁替代疗法在心脏病复发吸烟者中的应用：一项随机试验的可行性结果

IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

CJC Open Pub Date : 2025-08-01 DOI:10.1016/j.cjco.2025.05.005

Hassan Mir MD, MHI, MPH, FRCPC, FACP , Kerri-Anne Mullen PhD , Javad Heshmati PhD , Ashley Baldwin BAHsc , Evyanne Quirouette BSc , Emilie Serano RN, MN , Mustafa Coja BPHE, BA , Andrew L. Pipe MD , Robert D. Reid PhD

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引用次数: 0

摘要

背景：使用胱氨酸已被证明对戒烟有效。我们计划调查使用胱氨酸是否对复发恢复有效，并进行了一项随机试验，以评估确定试验的可行性。方法采用2组、单点、随机对照试验。患有心脏病的成年人积极参加戒烟计划，并且又吸烟了，他们被随机分配接受25天的胱氨酸或联合尼古丁替代疗法。主要结局是参与者招募率和治疗依从性，与目标相比较。次要结果包括治疗结束时的戒断和治疗对每天吸烟的影响以及烟草戒断症状。结果在18个月的时间里，我们筛选了62名复发吸烟者，确定了32名（52%）符合条件。我们招募了13名参与者（符合条件的41%），其中9名（69%）完成了研究。13名参与者中有5名（38.5%）在治疗期间≥80%的天数使用研究药物（胱氨酸组为50.0%，尼古丁替代治疗组为28.6%）。在第25天，胱氨酸组有1名戒烟者，尼古丁替代治疗组没有戒烟者（16.7%对0%）。在治疗过程中，每天的吸烟量减少了。结论需要对试验设计、试验过程和干预措施进行改进，才能使试验具有明确的实用性。为了提高招募水平，我们将在典型的戒烟计划实践中使用实用的设计，进行多地点研究，并扩大资格，包括具有其他临床条件的参与者。为了提高治疗依从性，我们将使用简化剂量的胞氨酸。最终试验的样本量将基于确定长期禁欲的临床有意义改变所需的数量。临床试验注册号nct04286295。

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Cytisine Use Vs Nicotine Replacement Therapy in Relapsed Smokers with Heart Disease: Feasibility Results from a Pilot Randomized Trial

Background

Cytisine use has proven efficacy for smoking cessation. We plan to investigate whether cytisine use is effective for relapse recovery and conducted a pilot randomized trial to assess the feasibility of a definitive trial.

Methods

A 2-group, single-site pilot randomized controlled trial was conducted. Adults with heart disease, who were actively enrolled in a smoking-cessation program and had relapsed to smoking, were randomly assigned to receive cytisine or combination nicotine replacement therapy for 25 days. Primary outcomes were rates of participant recruitment and treatment adherence, compared to targets. Secondary outcomes included end-of-treatment abstinence and treatment effects on cigarettes smoked per day and tobacco-withdrawal symptoms.

Results

Over the course of 18 months, we screened 62 relapsed smokers, identifying 32 (52%) who were eligible. We recruited 13 participants (41% of eligible), of whom 9 (69%) completed the study. A total of 5 of 13 participants (38.5%) used study medication on ≥ 80% of the days during the treatment period (50.0% in the cytisine group vs 28.6% in the nicotine replacement therapy group). At 25 days, 1 quitter was present in the cytisine group, and no quitters were present in the nicotine replacement therapy group (16.7% vs 0%). Cigarettes smoked per day decreased over the course of treatment.

Conclusions

Modifications to trial design, trial processes, and intervention delivery are required to make a definitive trial useful. To increase recruitment level, we will use a pragmatic design embedded within typical cessation-program practices, conduct a multisite study, and expand eligibility to include participants with other clinical conditions. To increase treatment adherence, we will use simplified dosing for cytisine. Sample size for the definitive trial will be based on the number needed to determine a clinically meaningful change in long-term abstinence.