The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking
ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-70
SponsorNew York State Psychiatric Institute
About this trial
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.
Eligibility criteria
Qualifiers
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
Physically healthy
No adverse reactions to study medications
21-70 years of age
Disqualifiers
Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, or any psychotic illness, including substance-induced psychosis
Physiological dependence on another substance, such as opioids or benzodiazepines, excluding caffeine, nicotine, and cannabis
Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders
Current suicide risk or a history of suicide attempt within the past year
Trial design
Treatments tested in this trial
- CI-581a
- CI-581b
- MBRP
- MET
Treatment groups
120 Participants
are divided into 4 treatment groupsSponsors and collaborators
New York State Psychiatric Institute
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov