Glutamatergic Modulation of Disordered Alcohol Use

NCT ID: NCT02539511

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-12-31

Brief Summary

Alcohol use disorders remain a significant public health problem. The pharmacological facilitation of behavioral treatment represents a promising strategy for addressing disordered drinking. Alcohol use disorders are recognized to be associated with various vulnerabilities that complicate the course of treatment and that may be amenable to glutamate modulators. The purpose of this randomized, double-blind, controlled trial is to test various glutamate modulators in conjunction with motivational enhancement therapy (MET) for alcohol use disorders.

Detailed Description

Individuals diagnosed with alcohol dependence will be randomized to receive a single infusion of glutamate modulators during week 2 while engaged in a 5-week course of MET. They will meet with staff twice weekly, except for week 2 during which they will present to the clinic three times. Clinic visits include MET sessions, psychiatric monitoring, assessments, and study procedures (e.g., medication administration).

Conditions

Alcohol Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CI-581a+MET

Administration of CI-581a during wk 2 at 0.71 mg/kg in the context of a 5 wk course of MET

Group Type: EXPERIMENTAL

CI-581a

Intervention Type: DRUG

Motivational Enhancement Therapy (MET)

Intervention Type: BEHAVIORAL

CI-581b+MET

Administration of CI-581b during wk 2 at 0.025 mg/kg in the context of a 5 wk course of MET

Group Type: ACTIVE_COMPARATOR

CI-581b

Intervention Type: DRUG

Motivational Enhancement Therapy (MET)

Intervention Type: BEHAVIORAL

Interventions

CI-581a

Intervention Type: DRUG

CI-581b

Intervention Type: DRUG

Motivational Enhancement Therapy (MET)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Active alcohol dependence. In the case of the use of other drugs, alcohol is designated as the primary drug. At least four heavy drinking day over the past 7 days (>4 drinks a day for males, >3 drinks for females) OR minimum weekly use of 35 drinks for males and 28 for females
• Physically healthy
• No adverse reactions to study medications
• 21-69 years of age
• Capacity to consent and comply with study procedures, including sufficient proficiency in English
• Seeking to reduce or stop alcohol use

Exclusion Criteria

• Meets criteria for current major depression, bipolar disorder, schizophrenia, any psychotic illness, including substance induced psychosis, and current substance-induced mood disorder.
• Physiological dependence on another substance requiring medical management, such as opiods or benzodiazepines, excluding caffeine, nicotine, and cannabis
• Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders. Significant dissociative symptoms
• Current suicide risk or a history of suicide attempt within the past year
• Inability to safely initiate 24 hours of abstinence from alcohol; repeated inability to initiate abstinence during the trial without incurring significant withdrawal; history of severe withdrawal phenomena over the past 6 months (e.g., withdrawal-related seizure); or self-reported inability to maintain abstinence for 24 hours without substantial distress.
• 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 end-stage AIDS, hypertension (>140/90), leukopenia, active hepatitis or other liver disease with elevated transaminase levels (< 2-3 X upper limit of normal will be considered acceptable if clotting factors are normal), renal failure, epilepsy, or untreated diabetes
• Previous history of study medication misuse or abuse, and a history of an adverse reaction/experience with prior exposure to study medications
• Recent history of significant violence (past 2 years)
• First degree relative with a psychotic disorder (bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis NOS)
• obesity
• On psychotropic or other medications whose effect could be disrupted by participation in the study
• BMI > 35

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Elias Dakwar

Assistant Professor of Clinical Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elias Dakwar, MD

Role: PRINCIPAL_INVESTIGATOR

NYSPI/Columbia

Locations

NYSPI

New York, New York, United States

Countries

United States

References

Dakwar E, Levin F, Hart CL, Basaraba C, Choi J, Pavlicova M, Nunes EV. A Single Ketamine Infusion Combined With Motivational Enhancement Therapy for Alcohol Use Disorder: A Randomized Midazolam-Controlled Pilot Trial. Am J Psychiatry. 2020 Feb 1;177(2):125-133. doi: 10.1176/appi.ajp.2019.19070684. Epub 2019 Dec 2.

Reference Type: DERIVED

PMID: 31786934 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R21AA023010

Identifier Type: NIH

Identifier Source: secondary_id

View Link

7014

Identifier Type: -

Identifier Source: org_study_id