Actively Recruiting
The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking
Led by New York State Psychiatric Institute · Updated on 2023-11-07
120
Participants Needed
1
Research Sites
251 weeks
Total Duration
On this page
Sponsors
N
New York State Psychiatric Institute
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The proposed project tests the efficacy of glutamate modulators in non-depressed individuals with alcohol use disorder (AUD); the primary hypothesis is that the glutamate modulator being tested reduces heavy drinking days compared to the active control. It also aims to investigate, using a 2 by 2 factorial (2x2) design, the hypothesis that the effects of the glutamate modulator are enhanced when combined with behavioral treatment.
CONDITIONS
Official Title
The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Active alcohol use disorder, with at least 4 heavy drinking days over the past 7 days (greater than 4 drinks a day for males, greater than 3 drinks for females) with alcohol as the primary drug
- Physically healthy
- No adverse reactions to study medications
- Aged between 21 and 70 years
- Able to consent and comply with study procedures, including sufficient proficiency in English
- Seeking to reduce or stop alcohol use
You will not qualify if you...
- Current major depression, bipolar disorder, schizophrenia, or any psychotic illness including substance-induced psychosis
- Physiological dependence on substances other than caffeine, nicotine, or cannabis
- Delirium, dementia, amnesia, cognitive, or dissociative disorders
- Current suicide risk or suicide attempt within the past year
- Unable to safely maintain 24 hours of abstinence from alcohol or history of severe withdrawal in past 6 months
- Pregnant or planning pregnancy during the study
- Cardiac conditions such as significant left ventricular hypertrophy, angina, arrhythmia, or mitral valve prolapse
- Unstable physical disorders like hypertension above 160/90, anemia, active hepatitis or liver disease beyond limits, epilepsy, or untreated diabetes
- HIV+ participants on ritonavir (Norvir) excluded
- History of misuse or adverse reactions to study medications
- Recent history of significant violence
- Use of psychotropic or other medications that might interfere with study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
NYSPI
New York, New York, United States, 10032
Actively Recruiting
Research Team
K
Kate O'Malley
CONTACT
E
Elias Dakwar, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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