Image

Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)

Recruiting
18 - 80 years of age
Both
Phase 2

Powered by AI

Overview

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.

Eligibility

Inclusion criteria:

  1. Males and females 18-80 years of age
  2. Fluency in English and a 6th grade or higher reading level
  3. 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)
  4. Last alcohol use and at least one heavy drinking day within the past 30 days
  5. Willingness to attend follow-up assessments at 13 weeks
  6. Willingness to submit to Urine Toxicology screenings

Exclusion criteria:

  1. Lifetime diagnosis of a psychotic disorder, not induced by drug use
  2. Current treatment with opioids or benzodiazepines, which may affect new learning
  3. Involvement in a legal case that may lead to incarceration during the study period
  4. Residential plans that would interfere with participation
  5. Medical illness that may significantly compromise cognition (e.g., Parkinson's, Alzheimer's, Huntington's chorea, moderate or greater TBI)
  6. An uncorrected sensory impairment (hearing or sight) that would seriously interfere with cognitive training
  7. Pre-morbid intelligence quotient (IQ) estimate below 70
  8. Unstable housing or lack of commitment to staying within a geographic area that would make follow-up unlikely
  9. 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
  10. Allergy to donepezil
  11. Unstable cardiovascular disease or unstable medical condition-clinically determined by a physician
  12. Imminent suicidal or homicidal risk
  13. Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential

Study details

Alcohol Use Disorder

NCT05042102

VA Connecticut Healthcare System

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.