Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 21 of 2439 for:    NMDA

Glutamatergic Modulation of Motivation Enhancement: A Pilot Feasibility Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02373124
Recruitment Status : Completed
First Posted : February 26, 2015
Results First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Elias Dakwar, New York State Psychiatric Institute

Brief Summary:
This study evaluates the feasibility of a treatment paradigm that involves naturalistic cocaine use opportunities in the context of psychotherapy aimed at utilizing these opportunities therapeutically.

Condition or disease Intervention/treatment Phase
Cocaine Use Disorders Drug: infusion of NMDA antagonist Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glutamatergic Modulation of Motivation Enhancement: A Pilot Feasibility Trial
Actual Study Start Date : December 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: open-label
52 minute infusion of NMDA antagonist
Drug: infusion of NMDA antagonist
52 minute infusion
Other Name: NMDA antagonist




Primary Outcome Measures :
  1. Cocaine Use [ Time Frame: 5 weeks ]
    Participants were provided choices to use up to 5 hits of cocaine on up to 2 occasions (cocaine versus money). Participants who chose cocaine (1 or more hits) during the first choice opportunity are administered a 52 minute infusion of 0.71 mg/kg ketamine the following day. Another choice opportunity occurs 24 hours later. The primary outcome is the choice participants made during these occasions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criterion Method of Ascertainment

  1. Active cocaine dependence with at least 8 days of use or at least 4 binges of large amounts (>$200/occasion) over the past 30 days, and displaying at least one positive utox during screening SCID, Psychiatric Interview, self-report, utox
  2. Physically healthy Laboratory tests (urinalysis, blood chemistry, 12-lead ECG in normal limits), physical examination, self-reported medical history
  3. No adverse reactions to study medications Subjects will be asked about previous exposure to ketamine and midazolam
  4. 21-55 years of age Self-reported age, verification with legal identification
  5. Capacity to consent and comply with study procedures, including sufficient proficiency in English A short written test about study procedures, SCID, psychiatric interview
  6. Seeking treatment Psychiatric Interview, self-report

Exclusion Criterion Method of Ascertainment

  1. Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, any psychotic illness, including substance induced psychosis, and current substance-induced mood disorder with HAMD score > 12. Psychiatric Interview, SCID, HAMD
  2. Physiological dependence on another substance, such as alcohol, opioids, or benzodiazepines, excluding caffeine, nicotine, and cannabis SCID, Psychiatric Interview
  3. Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders SCID, Psychiatric Interview
  4. Current suicide risk or a history of suicide attempt within the past year SCID, Psychiatric Interview
  5. Pregnant or interested in becoming pregnant during the study period Blood and urine pregnancy testing, self-report
  6. Any of the following cardiac conditions: clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse Laboratory tests (12-lead ECG in normal limits), physical examination, self-reported medical history
  7. Unstable physical disorders which might make participation hazardous such as end-stage AIDS, hypertension (>140/90), WBC < 3.5, active hepatitis or other liver disease with elevated transaminase levels (< 2-3 X upper limit of normal will be considered acceptable if PT/PTT is normal), renal failure (creat > 2, BUN >40), or untreated diabetes Physiological tests (urinalysis, blood chemistry, 12-lead ECG), physical examination, self-reported medical history
  8. Previous history of ketamine or midazolam misuse or abuse, and a history of an adverse reaction/experience with prior exposure to cocaine, ketamine or midazolam Physical examination, self-reported medical history
  9. Recent history of significant violence (past 2 years) SCID, Psychiatric Interview
  10. Abnormal pseudocholinesterase level Blood testing
  11. First degree relative with a psychotic disorder (bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis NOS) SCID, Psychiatric Interview
  12. BMI > 35, or a history of documented obstructive sleep apnea Physical examination, self-reported medical history
  13. On psychotropic or other medications whose effect could be disrupted by participation in the study Psychiatric interview, self-reported medical history
  14. Patients who cannot comply with study procedures during the initial hospitalization phase Study Performance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373124


Locations
Layout table for location information
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Layout table for investigator information
Principal Investigator: elias dakwar NYSPI

Layout table for additonal information
Responsible Party: Elias Dakwar, Assistant Professor of Clinical Psychiatry, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02373124     History of Changes
Other Study ID Numbers: 7051
First Posted: February 26, 2015    Key Record Dates
Results First Posted: April 24, 2019
Last Update Posted: April 24, 2019
Last Verified: April 2019