Alcohol Use DisorderPhase 2NCT05042102
Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)
A Phase 2 study testing Donepezil + Cognitive remediation therapy (CRT) in people with Alcohol Use Disorder, run by VA Connecticut Healthcare System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Donepezil + Cognitive remediation therapy (CRT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2022to 31 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
Gihyun Yoon, MD, 203-932-5711 ext. 7421, gihyun.yoon@yale.edu
About this study
Official title: The Combination of Donepezil and Cognitive Training for Treating Alcohol Use Disorder
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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Donepezil + Cognitive remediation therapy (CRT), Donepezil + Placebo CRT, Placebo medication + Cognitive remediation therapy (CRT), Placebo medication + Placebo CRT
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil + Cognitive remediation therapy (CRT)Combination product
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.
Donepezil + Placebo CRTCombination product
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.
Placebo medication + Cognitive remediation therapy (CRT)Combination product
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.
Placebo medication + Placebo CRTCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Donepezil + Cognitive remediation therapy (CRT) | Experimental | 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. Receives: Combination Product: Donepezil + Cognitive remediation therapy (CRT) |
| Donepezil + Placebo CRT | Experimental | 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. Receives: Combination Product: Donepezil + Placebo CRT |
| Placebo medication + Cognitive remediation therapy (CRT) | Experimental | 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. Receives: Combination Product: Placebo medication + Cognitive remediation therapy (CRT) |
| Placebo medication + Placebo CRT | Experimental | 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. Receives: Combination Product: Placebo medication + Placebo CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heavy drinking days
Heavy drinking days as measured by weekly Time Line Follow Back (TLFB)
Measured: 13 weeks of active intervention
Secondary outcomes (1)
Global neurocognitive functioning
Global neurocognitive functioning on a global index of neurocognitive function
Measured: At 7 weeks and at 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start8 Aug 2022
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Yale University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Gihyun Yoon, MD, Principal investigator, Yale University, VA Connecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042102
- Sponsor's protocol ID
- GY0010
- Other IDs
- 5R01AA029075
- Status last verified
- Jun 2026
- First submitted
- 3 Sep 2021
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Yoon G, Sofuoglu M, Petrakis IL, Pittman B, Bell MD. The combination of donepezil and cognitive training for improving treatment outcomes for alcohol use disorder: Design of a randomized controlled trial. Contemp Clin Trials. 2024 Oct;145:107657. doi: 10.1016/j.cct.2024.107657. Epub 2024 Aug 5.
PubMed 39111388
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination of Donepezil and Cognitive Training for Treating Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT05042102
- Acronym / sponsor ID
- GY0010
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Collaborators
- Yale University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Donepezil + Cognitive remediation therapy (CRT) | Experimental | Combination Product: 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. |
| Donepezil + Placebo CRT | Experimental | Combination Product: Donepezil + Placebo CRTSubjects 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. |
| Placebo medication + Cognitive remediation therapy (CRT) | Experimental | 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. |
| Placebo medication + Placebo CRT | Experimental | Combination Product: Placebo medication + Placebo CRTSubjects 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | Donepezil + Cognitive remediation therapy (CRT) |
| Donepezil + Placebo CRTSubjects 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. | Combination product | Donepezil + Placebo CRT |
| 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. | Combination product | Placebo medication + Cognitive remediation therapy (CRT) |
| Placebo medication + Placebo CRTSubjects 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. | Combination product | Placebo medication + Placebo CRT |
Primary outcome
Heavy drinking days
Time frame: 13 weeks of active intervention
Heavy drinking days as measured by weekly Time Line Follow Back (TLFB)
1 secondary outcome
Global neurocognitive functioning
Time frame: At 7 weeks and at 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Derived from this study: PubMed 39111388Yoon G, Sofuoglu M, Petrakis IL, Pittman B, Bell MD. The combination of donepezil and cognitive training for improving treatment outcomes for alcohol use disorder: Design of a randomized controlled trial. Contemp Clin Trials. 2024 Oct;145:107657. doi: 10.1016/j.cct.2024.107657. Epub 2024 Aug 5.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gihyun Yoon, MD principal investigator
Yale University, VA Connecticut Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Donepezil + Cognitive remediation therapy (CRT) in people with Alcohol Use Disorder, run by VA Connecticut Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gihyun Yoon, MD (203-932-5711 ext. 7421, gihyun.yoon@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heavy drinking days (time frame: 13 weeks of active intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05042102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.