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

This trial does not accept healthy volunteers

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

Design model

Factorial

Treatments tested in this trial

CI-581a
Drug
CI-581a during weeks 1 and 6 at 0.71 mg/kg
CI-581b
Drug
CI-581b during weeks 1 and 6 at 0.0125 mg/kg
MBRP
Behavioral
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
Behavioral
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).

Treatment groups

120 Participants

are divided into 4 treatment groups

Group A: CI-581a + MET/MBRPExperimental treatment 3 interventions

Group B: CI-581a + Medication ManagementExperimental treatment 1 intervention

Group C: CI-581b + MET/MBRPActive comparator 3 interventions

Group D: CI-581b + Medication ManagementActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

12 weeks

Secondary outcomes

Daily occurrence of drinking days

Comparing this outcome in between group that received CI-581a versus CI-581b, as well as between CI-581a groups.

Time frame

12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New York State Psychiatric Institute

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov

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