The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking: a Randomized, Controlled Trial
New York State Psychiatric Institute
Summary
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.
Description
Alterations in glutamate neurotransmission are an important target of pharmacotherapy for alcohol use disorder. Our investigations with glutamate modulators in drug and alcohol dependent individuals suggest that they may exert unique therapeutic effects on dependence-related vulnerabilities and may also address problem drinking in alcohol dependent individuals. The proposed project will expand on our prior research by testing the efficacy of glutamate modulators in a larger population of non-depressed individuals with alcohol use disorder (AUD); it also aims to investigate, using a 2 by 2 fact…
Eligibility
- Age range
- 21–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Active alcohol use disorder, with at least 4 heavy drinking day over the past 7 days (greater than 4 drinks a day for males, greater than 3 drinks for females). In the case of the use of other drugs, alcohol is designated as the primary drug 2. Physically healthy 3. No adverse reactions to study medications 4. 21-70 years of age 5. Capacity to consent and comply with study procedures, including sufficient proficiency in English 6. Seeking to reduce or stop alcohol use Exclusion Criteria: 1. Meets DSM IV criteria for current major depression, bipolar disorder, schizoph…
Interventions
- DrugCI-581a
CI-581a during weeks 1 and 6 at 0.71 mg/kg
- DrugCI-581b
CI-581b during weeks 1 and 6 at 0.0125 mg/kg
- BehavioralMBRP
MBRP will help with maintaining use reduction/abstinence.In this trial, 3 sessions will occur in the first 2 weeks following the second infusion (weeks 6 and 7), while one session a week will be administered in the latter 5 weeks (weeks 8 through 12).
- BehavioralMET
MET may help with goal setting and enhancing engagement with MBRP. In this trial, a standard 5-week MET platform will be provided to individuals randomized to receive behavioral treatment, with an additional session after each infusion (7 sessions total).
Location
- NYSPINew York, New York