Phase 2 N=8 Randomized Triple-blind Treatment

Glutamatergic Modulation of Cocaine-related Deficits

Cocaine Dependence

Bottom Line

View on ClinicalTrials.gov: NCT01790490 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2016

Primary outcome: Primary: Change in Cue Reactivity — 126; 18; 16 units on a scale (0-200), high is worse

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ketamine 0.41 mg/kg (Drug); Ketamine 0.71 mg/kg (Drug); Lorazepam 2 mg (Drug)
Age: Adult · 21+ yrs
Sex: All
Sponsor: New York State Psychiatric Institute
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Cue Reactivity	126; 18; 16	—
PRIMARY Change in Motivation to Quit	4.35; 3.2; 4.2	—

Summary

Cocaine dependence involves problematic neuroadaptations, such as heightened reactivity to cocaine cues, that may be responsive to pharmacological modulation of glutamatergic circuits. Despite promising preclinical findings with n-methyl-d-aspartate receptor (NMDAr) modulators, studies with human subjects have been unsuccessful to date. The purpose of this investigation is to examine the effects of the NMDAr antagonist ketamine, recently found to have potent therapeutic effects in humans, on cue-induced craving and impaired motivation for quitting cocaine in cocaine dependent participants, 24-hours post-infusion.

Eligibility Criteria

Inclusion Criteria

Active free-base cocaine dependence (at least 4 days of use over the past month, with at least 1 use per week); if the participant uses through another route (IN, IV), then the FB route is dominant (> 80% of occasions).
Physically healthy
No adverse reactions to study medications
21-52 years of age
Normal body weight
Responsive to drug cues
Capacity to consent

Exclusion Criteria

Seeking treatment or abstinence
DSM IV criteria for substance dependence (other than methamphetamine, cocaine, cannabis, or nicotine), or DSM IV criteria for abuse of ketamine or lorazepam
DSM-IV criteria for other Axis I psychiatric illness that may make participation hazardous such as schizophrenia, schizoaffective disorder, psychosis NOS, MDD, psychosis secondary to substances, or bipolar disorder
Delirium, Dementia, Amnesia, Cognitive Disorders, or dissociative disorders
Current suicide risk or a history of suicide attempt within the past 2 years
Current use of prescribed psychotropic medication
Pregnancy, nursing, or had a baby within the past 6 mo.
Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.
Unstable physical disorders which might make participation hazardous such as end-stage AIDS, hypertension (>140/90), anemia, active hepatitis or other liver disease, or diabetes
"Bad" reaction/experience with prior exposure to ketamine or lorazepam
History of significant violence
First degree relative with a psychotic disorder

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01790490). 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.