Last updated: November 7, 2023
Sponsor: VA Connecticut Healthcare System
Overall Status: Active - Recruiting
Phase
2
Condition
Alcohol Use Disorder
Alcohol Dependence
Substance Abuse
Treatment
Donepezil + Cognitive remediation therapy (CRT)
Placebo medication + Placebo CRT
Placebo medication + Cognitive remediation therapy (CRT)
Clinical Study ID
NCT05042102
GY0010
5R01AA029075
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
- 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 acurrent 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
Exclusion
Exclusion criteria:
- 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 interferewith cognitive training
- Pre-morbid intelligence quotient (IQ) estimate below 70
- Unstable housing or lack of commitment to staying within a geographic area that wouldmake follow-up unlikely
- Unwillingness to provide contact information of someone who can help study staffcontact the subjects in the event that study staff are unable to maintain contactdirectly
- Allergy to donepezil
- Unstable cardiovascular disease or unstable medical condition-clinically determined bya physician
- Imminent suicidal or homicidal risk
- Pregnant or nursing women, positive pregnancy test, or inadequate birth controlmethods in women of childbearing potential
Study Design
Total Participants: 160
Treatment Group(s): 4
Primary Treatment: Donepezil + Cognitive remediation therapy (CRT)
Phase: 2
Study Start date:
August 08, 2022
Estimated Completion Date:
May 31, 2026
Connect with a study center
VA Connecticut Healthcare System
West Haven, Connecticut 06516
United StatesActive - Recruiting
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