Effectiveness of Nicotine Replacement Therapy (NRT) and Bupropion for Smoking Cessation amongst opioid dependent subjects on agonist maintenance treatment: A Randomized Open-Label, Parallel-Group Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- i. Biochemically confirmed seven-day point prevalence abstinence at 1- and 3-month follow-up
研究概览
简要总结
High smoking prevalence among opioid-dependent patients, coupled with the associated comorbidity leading to elevated mortality rates, underscores the urgent need for intensified efforts addressing tobacco use in this population. The persistently low quit rates emphasize the critical gap in research and intervention. Importantly, a significant proportion of these patients express a willingness to quit tobacco, highlighting a potential avenue for targeted support. Bupropion and Nicotine replacement therapy are effective and first line pharmacological management methods for tobacco cessation. Opioid agonist maintenance treatment provides a unique opportunity to provide comorbid tobacco dependence management. However, the effectiveness of tobacco cessation strategies in the context of comorbid opioid dependence syndrome remains inadequately studied, with only one known study conducted in India, requiring the need for further research and tailored interventions to effectively manage this condition
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •Age 18 to 60 years Male Current (last 1 month) user of tobacco by smoking route Diagnosed with nicotine dependence, current use as per ICD-11 criteria Currently following up in NDDTC OPD for Opioid agonist maintenance treatment (Buprenorphine-Naloxone) with 80% medication dispensing Willing to participate in follow up at 4-6 weeks and 12-14 weeks.
排除标准
- •History of co-morbid psychiatric illnesses (as per clinical interview) Current (last 1 month)Dependence on drugs other than opioid and nicotine Current users of smokeless tobacco Has ever received tobacco cessation intervention (except simple advice from a health care professional) in the past 3 months Unwilling to give informed consent Contraindication for Nicotine replacement therapy (accelerated hypertension, post-myocardial infarction period (2 weeks), hypersensitivity to NRT) or Bupropion (Seizure episode, eating disorder).
结局指标
主要结局
i. Biochemically confirmed seven-day point prevalence abstinence at 1- and 3-month follow-up
时间窗: 1 month and 3 months
ii. Reduction in smoking use as measured by self-reported amount of tobacco use(number of beedi or cigarettes)
时间窗: 1 month and 3 months
次要结局
- i. Continuous abstinence from smoking at 1- and 3-month follow-up (Complete abstinence beginning on the target quit date till the date of assessment)(ii. Change in the stage of motivation)
研究者
Dr Muhammed Jadeer K
National Drug Dependence Treatment Centre