CTRI/2024/12/077636尚未招募不适用
Comparison of short-term drinking outcomes between distant patients with alcohol dependence treated with postal delivery of oral naltrexone and tele-follow-up (tele-PoN) versus usual dispensing of oral naltrexone along with telefollow-up (tele-DoN): an exploratory randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To compare the time to first episode of heavy drinking between distant patients with alcohol dependence treated with tele-PoN, teleDoN and TAU
研究概览
简要总结
Overall 99 patients will be recruited through eligibility criteria. They will be divided into three groups based on computer based random number generator and it will be open label. The groups will be compared based upon postal delivery of oral naltrexone through tele-follow up with usual dispensing via tele-follow up and change in consumption pattern of alcohol will be documented with screening tools.
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
- •ICD-11 alcohol dependence patients taking 50 mg of oral naltrexone (as per standard guidelines issues by MoHFW, GoI and CPG,IPS) at least for one month.
- •Distant patients as per operational definition.
- •Patients with valid postal address in India where speed post services of Indian Postal departmental are available.
- •Availability of receiving person at the delivery point.
- •Patient should be ready for physically visiting the ATF after 12 weeks for follow up.
- •Patients having a valid phone number with mobile handset preferably smartphone where he can be contacted for tele-reminders.
排除标准
- •Diagnosed case of severe mental illness.
- •substance dependence with active usage.(except alcohol, tobacco and nicotine)
- •Contraindications of prescribing naltrexone.
- •Complete abstinence from alcohol in iast one month.
- •Patients in active alcohol withdrawal as per clinical assessment.
结局指标
主要结局
To compare the time to first episode of heavy drinking between distant patients with alcohol dependence treated with tele-PoN, teleDoN and TAU
时间窗: At baseline, 4 weeks, 8 weeks, 12 weeks
次要结局
- To compare heavy drinking days, number of drinking days, drink per drinking days & alcohol craving among distant patients with alcohol dependence treated with tele-PoN, tele-DoN & TAU.(To compare adherence to treatment among tele-PoN, tele-DoN & TAU arms.)
研究者
Dr Raviraj Singh Nagarkoti
AIIMS KALYANI
研究点 (1)
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