Glutamatergic Modulation of Motivation Enhancement: A Pilot Feasibility Trial

Cocaine Use Disorders Clinical Trial

Official title:

Glutamatergic Modulation of Motivation Enhancement: A Pilot Feasibility Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373124
• Other study ID #: 7051
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2014
• Est. completion date: October 2016

Study information

• Verified date: January 2020
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Use Disorders

Intervention

Drug:
• infusion of NMDA antagonist
52 minute infusion

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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