What side effects are associated with this type of intervention?

Common treatments for alcoholism include pharmacotherapy and behavioral interventions. Donepezil, a cholinesterase inhibitor, is being studied for its potential benefits in combination with cognitive remediation therapy. Known side effects of cholinesterase inhibitors like Donepezil include gastrointestinal issues (nausea, vomiting, diarrhea), muscle cramps, fatigue, and insomnia. Behavioral interventions, such as cognitive remediation therapy, generally have fewer physical side effects but may cause emotional or psychological stress as patients confront and modify their behaviors.

What prior FDA approvals exist?

FDA-approved treatments for alcoholism include medications such as naltrexone, acamprosate, and disulfiram. Naltrexone works by blocking opioid receptors to reduce cravings and the rewarding effects of alcohol. Acamprosate helps to stabilize chemical balance in the brain that would otherwise be disrupted by alcohol withdrawal. Disulfiram creates an adverse reaction when alcohol is consumed, deterring individuals from drinking. These treatments are often combined with behavioral interventions like cognitive-behavioral therapy (CBT) to enhance their effectiveness. While donepezil, a cholinesterase inhibitor, is not FDA-approved for alcoholism, it is being studied in combination with cognitive remediation therapy to evaluate its potential benefits in reducing heavy drinking in patients with alcohol use disorder.

What other types of research exist?

Promising novel alternatives for treating alcoholism in 2024 include the use of medications like Naltrexone, Acamprosate, and Disulfiram, which have shown efficacy in reducing alcohol consumption and preventing relapse. Additionally, emerging therapies such as the use of Gabapentin and Topiramate are being explored for their potential benefits. Behavioral interventions like Cognitive Behavioral Therapy (CBT), Motivational Enhancement Therapy (MET), and Contingency Management (CM) continue to be effective. Digital and internet-based interventions are also gaining traction as accessible and scalable options for treatment.

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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

Must not have

Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 7 weeks and at 13 weeks

Summary

This trial is testing if a combination of a medication called donepezil and mental training exercises can help people who drink heavily due to alcohol use disorder. The goal is to see if this combination works better.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant, nursing, or using inadequate birth control.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Heavy drinking days

Secondary study objectives

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 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cholinesterase inhibitors, like donepezil, increase acetylcholine levels in the brain, enhancing cognitive function and potentially reducing cravings and improving decision-making in alcoholism patients. Cognitive remediation therapy, a behavioral intervention, aims to improve cognitive skills through structured tasks and exercises, helping patients develop better coping strategies and reduce relapse risk. Combining these treatments addresses both neurochemical and cognitive aspects of addiction, offering a comprehensive approach to managing alcoholism.

Variance in the Efficacy of Brief Interventions to Reduce Hazardous and Harmful Alcohol Consumption Between Injury and Noninjury Patients in Emergency Departments: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.