A Double-blind, Cross-over, Randomised Controlled Trial to Compare the Effectiveness of Higher Dose Oral Naltrexone with Standard Dose Oral Naltrexone in Moderate to Severe Alcohol Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- 1. Number of participants that become abstinent:
研究概览
简要总结
The study will be a double-blind crossover randomised controlled trial to compare the effectiveness of 100 mg oral naltrexone with 50 mg naltrexone in moderate to severe alcohol use disorder. It will be a non-funded, hospital-based prospective study for 6 months for each of the 26 patients to be recruited.The primary outcome measures will be the the rate of abstinence, while the secondary outcome measure will be tolerability or adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •Resident of Gorakhpur and literate enough to understand the questionnaires, fulfilling DSM-5 criteria for alcohol use disorder with severity of alcohol dependence questionnaire (SAD-Q) score of at least 16 (assessed for the preceding 6 months)and Patients willing for inpatient detoxification and abstinence for 1 week.
排除标准
- •Presence of other moderate to severe substance use disorders except tobacco.
- •Presence of any major psychiatric condition (except subsyndromal depression or anxiety).
- •Any acute medical or neurological condition or intellectual disability.
- •Any chronic medical conditions (malignancy or chronic pain conditions) that may pose a contraindication for opioid antagonist treatment.
- •History of hypersensitivity to naltrexone in the past.
- •Active use of any opioids (use of any opioids in the last 7 days).
- •Evidence of compromised liver function, with liver enzymes raised more than three times the upper normal limit.
结局指标
主要结局
1. Number of participants that become abstinent:
时间窗: At baseline, at the end of 1st month, 2nd month, 3rd month, 4th month, 5th month, and 6th month.
2. If relapse, the number of days of abstinence
时间窗: At baseline, at the end of 1st month, 2nd month, 3rd month, 4th month, 5th month, and 6th month.
3. Number of lapses
时间窗: At baseline, at the end of 1st month, 2nd month, 3rd month, 4th month, 5th month, and 6th month.
4. Number of drinks per day: both for lapse and relapse
时间窗: At baseline, at the end of 1st month, 2nd month, 3rd month, 4th month, 5th month, and 6th month.
5. Severity of craving: The severity of craving will be assessed and quantified using the Penn Alcohol Craving Scale.
时间窗: At baseline, at the end of 1st month, 2nd month, 3rd month, 4th month, 5th month, and 6th month.
6. Treatment completion and dropout in each group.
时间窗: At baseline, at the end of 1st month, 2nd month, 3rd month, 4th month, 5th month, and 6th month.
次要结局
- Serum aspartate aminotransferase (SGOT) and alanine aminotransferase (SGPT) levels.(Treatment emergent adverse events)
研究者
Dr LALCHHANDAMA HAUHNAR
Department of Psychiatry, All India Institute of Medical Sciences, Gorakhpur