← Back to Search

Donepezil + Cognitive Training for Alcoholism

Phase 2

Recruiting

Led By Gihyun Yoon, MD

Research Sponsored by VA Connecticut Healthcare System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Fluency in English and a 6th grade or higher reading level

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 7 weeks and at 13 weeks

Awards & highlights

Study Summary

This trial is testing whether a combination of donepezil and cognitive remediation therapy can help reduce heavy drinking in patients with alcohol use disorder, compared to placebo.

Who is the study for?

This trial is for adults aged 18-80 with alcohol use disorder who can read English at a 6th grade level or higher. Participants must have had heavy drinking days recently and be willing to attend follow-ups and undergo Breathalyzer and urine tests. Exclusions include those with certain mental health conditions, current opioid/benzodiazepine treatment, significant cognitive impairments, sensory issues affecting training, legal/incarceration risks, unstable housing or medical conditions, low IQ estimates, pregnancy/nursing women, or donepezil allergies.Check my eligibility

What is being tested?

The study is testing if donepezil combined with cognitive remediation therapy (CRT) helps reduce heavy drinking in people with alcohol use disorder more effectively than placebo treatments. It's a double-blind trial where participants are randomly assigned to receive either the drug plus CRT, the drug plus placebo CRT, placebo medication plus CRT or both placebos.See study design

What are the potential side effects?

Donepezil may cause side effects like nausea, diarrhea, insomnia, muscle cramps and fatigue. Cognitive remediation therapy generally does not have physical side effects but could potentially lead to temporary increases in stress or frustration during challenging tasks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can fluently speak and read English at a 6th grade level or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 7 weeks and at 13 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 7 weeks and at 13 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 7 weeks and at 13 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Heavy drinking days

Secondary outcome measures

Global neurocognitive functioning

Trial Design

4Treatment groups

Experimental Treatment

Group I: Placebo medication + Placebo CRTExperimental Treatment1 Intervention

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.

Group II: Placebo medication + Cognitive remediation therapy (CRT)Experimental Treatment1 Intervention

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.

Group III: Donepezil + Placebo CRTExperimental Treatment1 Intervention

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.

Group IV: Donepezil + Cognitive remediation therapy (CRT)Experimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Connecticut Healthcare SystemLead Sponsor

81 Previous Clinical Trials

6,550 Total Patients Enrolled

11 Trials studying Alcoholism

570 Patients Enrolled for Alcoholism

Yale UniversityOTHER

1,848 Previous Clinical Trials

2,737,658 Total Patients Enrolled

84 Trials studying Alcoholism

10,219 Patients Enrolled for Alcoholism

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

800 Previous Clinical Trials

1,362,837 Total Patients Enrolled

423 Trials studying Alcoholism

985,548 Patients Enrolled for Alcoholism

Media Library

Cognitive Remediation Therapy (CRT) Clinical Trial Eligibility Overview. Trial Name: NCT05042102 — Phase 2

Alcoholism Research Study Groups: Donepezil + Cognitive remediation therapy (CRT), Donepezil + Placebo CRT, Placebo medication + Cognitive remediation therapy (CRT), Placebo medication + Placebo CRT

Alcoholism Clinical Trial 2023: Cognitive Remediation Therapy (CRT) Highlights & Side Effects. Trial Name: NCT05042102 — Phase 2

Cognitive Remediation Therapy (CRT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05042102 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What further investigations have been done on the effects of combining Donepezil and Cognitive remediation therapy (CRT)?

"At the current moment, 14 active trials have been established for Donepezil + Cognitive Remediation Therapy (CRT). 2 of these studies are in their final phase. The bulk of clinical research on this treatment is centered in Hallandale Beach, Florida; however there are 26 total sites that offer it as an option."

Answered by AI

Does this trial extend its criteria to those of lesser age?

"As indicated by the selection criteria, patients must be of adult age (18+) and no more than 80 years old in order to join this medical trial."

Answered by AI

Does this research mark a groundbreaking exploration of its field?

"Donepezil + Cognitive remediation therapy (CRT) has been rigorously investigated, beginning with a clinical trial conducted by Dong-A Pharmaceutical Co., Ltd. in 2013 involving 210 patients. After the initial research was completed and approved, 14 more studies have since begun spread across 17 urban centres and 7 different nations."

Answered by AI

Do I meet the criteria to participate in this clinical trial?

"To qualify for this clinical study, participants must present with alcoholism and be between the age of majority and 80 years old. As of now, 160 individuals are being sought out for recruitment."

Answered by AI

Is the combination of Donepezil and Cognitive Remediation Therapy sanctioned by the Food & Drug Administration?

"As this is a phase 2 trial, indicating that there are some safety-related data points but no efficacy information available yet, our team at Power gave Donepezil + Cognitive Remediation Therapy (CRT) a score of 2."

Answered by AI

How many volunteers have enrolled in this research project?

"Affirmative. The details posted on clinicaltrials.gov demonstrate that this trial, which was initially shared on August 8th 2022 is actively recruiting participants. 160 individuals are required to join from 1 particular medical centre."

Answered by AI

To what particular condition or conditions are Donepezil and Cognitive Remediation Therapy typically utilized?

"Donepezil plus Cognitive Remediation Therapy (CRT) is the therapeutic approach of choice for Alzheimer's disease, with proven efficacy in mild dementia of the Alzheimer's type, vascular dementia and other associated conditions."

Answered by AI

Are there any opportunities to participate in this research project at the moment?

"This clinical trial is actively enlisting participants, as evidenced by the data provided on clinicaltrials.gov. The study was published on August 8th 2022 and updated most recently on August 25th 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)

2022. "Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05042102.

All > Alcoholism > Aricept