The Combination of Donepezil and Cognitive Training for Treating Alcohol Use Disorder (NCT04318639) | Clinical Trial Compass
CompletedPhase 2/3
The Combination of Donepezil and Cognitive Training for Treating Alcohol Use Disorder
United States15 participantsStarted 2018-08-17
Plain-language summary
This is an open label feasibility trial to learn whether the combination of donepezil and cognitive remediation therapy (Donepezil + CRT) may improve neurocognitive functioning and decreasing alcohol use in Veterans with alcohol use disorder who have mild cognitive impairment (AUD-MCI). The study will determine the acceptability and adherence to treatment and preliminary evidence for efficacy. The study will recruit 15 newly recovering Veterans individuals with AUD-MCI for a 13-week, open-label, single-arm pilot study with sobriety and cognitive assessments at baseline and at 13-week follow-up.
Who can participate
Age range
21 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males and females 21-80 years of age
* Fluency in English and a 6th grade or higher reading level
* Meets DSM-V criteria for a current Alcohol Use Disorder
* Referred for the study within 30 days of detoxification or last substance use according to medical records
* Willingness to attend follow-up assessments at 13 weeks
* Willingness to submit to Breathalyzer screenings and Urine Toxicology screenings.
* Meets MCI criteria with greater than 1.5 SD below pre-morbid IQ estimate or 1.5 SD below standard norms on at least 1 key neurocognitive MCI related variable (Learning and Memory, Delayed Recall, Executive Function, Working Memory).
Exclusion Criteria:
* Lifetime diagnosis of a psychotic disorder, not induced by drug use.
* Current prescribed treatment of opioids or benzodiazepines, which may affect new learning Involvement in a legal case that may lead to incarceration during 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 IQ estimate below 70.
* Unstable housing or lack of commitment to staying within a geographic area that would make follow-up possible.
* Unwillingness to provide contact information of someone who can help study staff contact the participant in t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Global Index of AUD recovery
Timeframe: 13 weeks
2
Global Composite T-Score of MCI related neurocognitive measures.