NCT02539511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 23, 2019

Completed
Last Updated

February 11, 2020

Status Verified

January 1, 2020

Enrollment Period

2.2 years

First QC Date

August 21, 2015

Results QC Date

January 25, 2019

Last Update Submit

January 31, 2020

Conditions

Alcohol Dependence

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Demonstrating Alcohol Abstinence in the Control (Midazolam) Group Versus the Active (Ketamine) Group

    Percentage of participants demonstrating alcohol abstinence in the control (midazolam) group versus the active (ketamine) group

    21 days post-infusion

Study Arms (2)

CI-581a+MET

EXPERIMENTAL

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

Drug: CI-581aBehavioral: Motivational Enhancement Therapy (MET)

CI-581b+MET

ACTIVE COMPARATOR

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

Drug: CI-581bBehavioral: Motivational Enhancement Therapy (MET)

Interventions

CI-581aDRUG
CI-581a+MET
CI-581bDRUG
CI-581b+MET
Motivational Enhancement Therapy (MET)BEHAVIORAL
CI-581a+METCI-581b+MET

Eligibility Criteria

Age21 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYSPI

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 31786934DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Elias Dakwar, MD
Organization
New York State Psychiatric Institute
elias.dakwar@nyspi.columbia.edu
6467748728

Study Officials

  • Elias Dakwar, MD

    NYSPI/Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Psychiatry

Study Record Dates

First Submitted

August 21, 2015

First Posted

September 3, 2015

Study Start

July 1, 2015

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

February 11, 2020

Results First Posted

April 23, 2019

Record last verified: 2020-01

Locations

US(1)