The Combination of Donepezil and Cognitive Training for Treating Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Heavy drinking days
研究概览
简要总结
The goal of the project is to evaluate whether donepezil + cognitive remediation therapy is superior to placebo in reducing heavy drinking in patients with alcohol use disorder in a double-blind, placebo-controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females 18-80 years of age
- •Fluency in English and a 6th grade or higher reading level
- •Meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a current alcohol use disorder (subjects should have a primary alcohol use disorder [AUD] diagnosis, but may have concurrent occasional use of other substances)
- •Last alcohol use and at least one heavy drinking day within the past 30 days
- •Willingness to attend follow-up assessments at 13 weeks
- •Willingness to submit to Urine Toxicology screenings
排除标准
- •Lifetime diagnosis of a psychotic disorder, not induced by drug use
- •Current treatment with opioids or benzodiazepines, which may affect new learning
- •Involvement in a legal case that may lead to incarceration during the study period
- •Residential plans that would interfere with participation
- •Medical illness that may significantly compromise cognition (e.g., Parkinson's, Alzheimer's, Huntington's chorea, moderate or greater TBI)
- •An uncorrected sensory impairment (hearing or sight) that would seriously interfere with cognitive training
- •Pre-morbid intelligence quotient (IQ) estimate below 70
- •Unstable housing or lack of commitment to staying within a geographic area that would make follow-up unlikely
- •Unwillingness to provide contact information of someone who can help study staff contact the subjects in the event that study staff are unable to maintain contact directly
- •Allergy to donepezil
- •Unstable cardiovascular disease or unstable medical condition-clinically determined by a physician
- •Imminent suicidal or homicidal risk
- •Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential
研究组 & 干预措施
Donepezil + Cognitive remediation therapy (CRT)
Subjects in this arm will receive (1) donepezil and (2) cognitive remediation therapy (CRT). Subjects will take 5 mg/day of oral donepezil in the evening for the first 4 weeks, then 10 mg/day of oral donepezil in the evening until week 13.
干预措施: Donepezil + Cognitive remediation therapy (CRT) (Combination Product)
Donepezil + Placebo CRT
Subjects in this arm will receive (1) donepezil and (2) placebo CRT. Subjects will take 5 mg/day of oral donepezil in the evening for the first 4 weeks, then 10 mg/day of oral donepezil in the evening until week 13.
干预措施: Donepezil + Placebo CRT (Combination Product)
Placebo medication + Cognitive remediation therapy (CRT)
Subjects in this arm will receive (1) placebo medication and (2) cognitive remediation therapy (CRT). Subjects will take placebo oral medication in the evening for the first 4 weeks, then placebo oral medication in the evening until week 13.
干预措施: Placebo medication + Cognitive remediation therapy (CRT) (Combination Product)
Placebo medication + Placebo CRT
Subjects in this arm will receive (1) placebo medication and (2) placebo CRT. Subjects will take placebo oral medication in the evening for the first 4 weeks, then placebo oral medication in the evening until week 13.
干预措施: Placebo medication + Placebo CRT (Combination Product)
结局指标
主要结局
Heavy drinking days
时间窗: 13 weeks of active intervention
Heavy drinking days as measured by weekly Time Line Follow Back (TLFB)
次要结局
- Global neurocognitive functioning(At 7 weeks and at 13 weeks)