Glutamatergic Modulation of Motivation Enhancement: A Pilot Feasibility Trial

NCT02373124 | Completed Phase 1 Results DMC

• 1 other identifier: 7051
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Use Disorders

Outcome Measures

Primary Outcomes (1)

• Cocaine Use

  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

  5 weeks

Study Arms (1)

open-label

EXPERIMENTAL

52 minute infusion of NMDA antagonist

Drug: infusion of NMDA antagonist

Interventions

infusion of NMDA antagonist DRUG

52 minute infusion

Also known as: NMDA antagonist

open-label

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

GluN2C-2D antagonist UBP145

Results Point of Contact

• Title: Elias Dakwar, MD
• Organization: New York State Psychiatric Institute

elias.dakwar@nyspi.columbia.edu

6467748728

Study Officials

• elias dakwar

  NYSPI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: February 26, 2015
• Study Start: December 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 5, 2020
• Results First Posted: April 24, 2019

Record last verified: 2020-01

Locations

US (1)