Phase 2 N=18 Randomized Quadruple-blind Treatment

The Effect of Glutamatergic Modulation on Cocaine Self-administration

Cocaine Dependence

Bottom Line

View on ClinicalTrials.gov: NCT02596022 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2017

Primary outcome: Primary: Number of Choices to Self-administer Cocaine (Out of 5 Choices) — 1.61; 4.33 number of cocaine choices

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CI-581a (Drug); CI-581b (Drug)
Age: Adult · 21+ yrs
Sex: All
Sponsor: New York State Psychiatric Institute
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Choices to Self-administer Cocaine (Out of 5 Choices)	1.61; 4.33	—

Summary

Repeated drug consumption may progress to problematic use by triggering neuroplastic adaptations that attenuate sensitivity to natural rewards while increasing reactivity to craving and drug cues. Converging evidence suggests that glutamate modulation may work to correct these adaptations and rapidly restore motivation for delayed non-drug rewards relative to immediate drug use. Using an established laboratory model aimed at evaluating behavioral shifts in the salience of cocaine now vs. money later, the investigators will test the effect of CI-581a on cocaine self-administration as compared to the active control.

Eligibility Criteria

Inclusion Criteria

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
Physically healthy
No adverse reactions to study medications
21-55 years of age
Capacity to consent and comply with study procedures, including sufficient proficiency in English
Not seeking treatment

Exclusion Criteria

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.
Physiological dependence on another substance, such as alcohol, opioids, or benzodiazepines, excluding caffeine, nicotine, and cannabis
Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders
Current suicide risk or a history of suicide attempt within the past year
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), WBC 2, BUN >40), or untreated diabetes
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
Recent history of significant violence (past 2 years)
Abnormal pseudocholinesterase level
First degree relative with a psychotic disorder (bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis NOS)
BMI > 35, or a history of documented obstructive sleep apnea
On psychotropic or other medications whose effect could be disrupted by participation in the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02596022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.