The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking
2 other identifiers
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2019
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2019
CompletedFirst Posted
Study publicly available on registry
September 10, 2019
CompletedStudy Start
First participant enrolled
November 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedNovember 7, 2023
November 1, 2023
4.8 years
September 4, 2019
November 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Daily occurrence of Heavy Drinking Days (HDD)
Defined as \>4 drinks/day for men; \>3 drinks for women. Comparing this outcome between groups that receive CI-581a versus CI-581b, as well as between CI-581a groups.
12 weeks
Secondary Outcomes (1)
Daily occurrence of drinking days
12 weeks
Study Arms (4)
CI-581a + MET/MBRP
EXPERIMENTALAdministration of CI-581a during weeks 1 and 6 at 0.71 mg/kg in the context of a 12 wk outpatient treatment (behavioral treatment combination of MET/MBRP will be provided)
CI-581a + Medication Management
EXPERIMENTALAdministration of CI-581a during weeks 1 and 6 at 0.71 mg/kg in the context of a 12 wk outpatient treatment ( no MET/MBRP sessions will be provided, only general check-ins and psychiatrist visits)
CI-581b + MET/MBRP
ACTIVE COMPARATORAdministration of CI-581b during weeks 1 and 6 at 0.0125 mg/kg in the context of a 12 wk outpatient treatment (behavioral treatment combination of MET/MBRP will be provided)
CI-581b + Medication Management
ACTIVE COMPARATORAdministration of CI-581b during weeks 1 and 6 at 0.0125 mg/kg in the context of a 12 wk outpatient treatment (no MET/MBRP sessions will be provided, only general check-ins and psychiatrist visits)
Interventions
CI-581a during weeks 1 and 6 at 0.71 mg/kg
CI-581b during weeks 1 and 6 at 0.0125 mg/kg
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).
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).
Eligibility Criteria
You may qualify if:
- 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
- years of age
- Capacity to consent and comply with study procedures, including sufficient proficiency in English
- Seeking to reduce or stop alcohol use
You may not qualify if:
- 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
- Inability to safely initiate 24 hours of abstinence from alcohol, as evidenced by CIWA greater than 10 during screening; history of severe withdrawal phenomena over the past 6 months (e.g., inpatient stabilization, withdrawal-related seizure); or self-reported inability to maintain abstinence for 24 hours.
- Pregnant or interested in becoming pregnant during the study period
- Any of the following cardiac conditions: clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse
- Unstable physical disorders which might make participation hazardous such as hypertension (\>160/90), anemia, active hepatitis or other liver disease (transaminase levels \< 2-3 X the upper limit of normal will be considered acceptable), epilepsy, or untreated diabetes. Participants reporting HIV+ status will be asked to provide information about their current treatment, including all medications. Participants who are on the antiretroviral ritonavir (Norvir) will be excluded due to the possibility that study medications in combination with this medication may increase the risk of drug-induced hepatitis.
- Previous history of misuse or abuse of study medications, and a history of an adverse reaction/experience with prior exposure to study medications
- Recent history of significant violance
- On psychotropic or other medications whose effect could be disrupted by participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYSPI
New York, New York, 10032, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elias Dakwar, MD
NYSPI/Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Clinical Psychiatry
Study Record Dates
First Submitted
September 4, 2019
First Posted
September 10, 2019
Study Start
November 8, 2019
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
November 7, 2023
Record last verified: 2023-11