CompletedNCT02596022Updated Jun 15, 2018Results posted

The Effect of Glutamatergic Modulation on Cocaine Self-administration

A Phase 2 interventional study of CI-581a and CI-581b in Cocaine Dependence, sponsored by New York State Psychiatric Institute. Completed. Open to participants aged 21 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-06-15.

Sponsored by New York State Psychiatric Institute · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 18
Allocation: Randomized
Ages: 21 Years to 55 Years
Sex: All

Study 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.

Conditions studied

Cocaine Dependence

Browse trials for

Cocaine-Related Disorders 415

In context

Cocaine-Related Disorders

415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.

This study's enrollment of 18 is below the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.

Browse Cocaine-Related Disorders studies →

Lead sponsor

New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 \< 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
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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 18 participants (actual)

Study arms

Experimental
CI-581a
Administration of CI-581a followed 2 weeks later by CI-581b
Drug: CI-581a · Drug: CI-581b
Active comparator
CI-581b
Administration of CI-581b followed 2 weeks later by CI-581a
Drug: CI-581a · Drug: CI-581b

Interventions

DrugCI-581a
a 50 minute infusion 24 hours prior to cocaine self-administration session
DrugCI-581b
a 50 minute infusion 24 hours prior to cocaine self-administration session

What researchers measure

Primary outcomes

Number of Choices to Self-administer Cocaine (Out of 5 Choices)
Participants provided 5 choices (cocaine 25 mg now vs. $11 later), with choices spaces 15 minutes apart over the course of the session.
Time frame: 24 hours post-infusion

Results

Posted Oct 17, 2017

Participant flow

Participant flow — Overall Study
Milestone	CI-581a First, Followed by CI-581b	CI-581b First, Followed by CI-581a
Started	10	8
Completed	10	8
Not completed	0	0

Outcome measures

PrimaryNumber of Choices to Self-administer Cocaine (Out of 5 Choices)

Participants provided 5 choices (cocaine 25 mg now vs. $11 later), with choices spaces 15 minutes apart over the course of the session.

Time frame:: 24 hours post-infusion
Reported as:: Mean · number of cocaine choices

Number of Choices to Self-administer Cocaine (Out of 5 Choices)
number of cocaine choices	CI-581a	CI-581b
Number of Choices to Self-administer Cocaine (Out of 5 Choices)	1.61 ± 1.3	4.33 ± 1.8

Adverse events

Collected over 6 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
CI-581a First, Followed by CI-581b	0/10 (0%)	0/10 (0%)	0/10 (0%)
CI-581b First, Followed by CI-581a	0/8 (0%)	0/8 (0%)	0/8 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	CI-581a First, Followed by CI-581b	CI-581b First, Followed by CI-581a	Total
Mean	48.6 ± 6.1	48.6 ± 6.1	48.6 ± 6.1

Sex: Female, Male
Sex: Female, Male(Participants)	CI-581a First, Followed by CI-581b	CI-581b First, Followed by CI-581a	Total
Female	4	5	9
Male	6	3	9

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	CI-581a First, Followed by CI-581b	CI-581b First, Followed by CI-581a	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	8	6	14
White	2	2	4
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	CI-581a First, Followed by CI-581b	CI-581b First, Followed by CI-581a	Total
United States	10	8	18

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02596022
Lead sponsor: New York State Psychiatric Institute
Responsible party: Elias Dakwar (research psychiatrist, New York State Psychiatric Institute) — Principal investigator
First posted: Nov 4, 2015
Start date: Jun 2013
Primary completion: Jun 2015
Completion: Jul 2015
Results posted: Oct 17, 2017
Last update: Jun 15, 2018

Study contacts

Elias Dakwar, MD

principal investigator · Columbia College of Physicians and Surgeons

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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