Trial Outcomes & Findings for The Effect of Brief Potent Glutamatergic Modulation on Cocaine Dependence (NCT NCT01535937)

Last Updated: 2019-05-01

Results Overview

Number of participants who use cocaine and drop from study. During phase 2, patients will be assessed twice weekly by TLFB and urine toxicology for cocaine use. The day of first use will determine the length of time that transpired from discharge to the first lapse onto cocaine.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

55 participants

Primary outcome timeframe

Over the four week period following discharge from the inpatient unit at Day 5

Results posted on

2019-05-01

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine 0.5 mg/kg of ketamine IV over 40 minutes Ketamine: 0.5 mg/kg IV over 40 minutes	Midazolam 0.025 mg/kg IV over 40 minutes Midazolam: 0.025 mg/kg IV over 40 minutes
Overall Study STARTED	27	28
Overall Study COMPLETED	27	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Brief Potent Glutamatergic Modulation on Cocaine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine n=27 Participants 0.5 mg/kg of ketamine IV over 40 minutes Ketamine: 0.5 mg/kg IV over 40 minutes	Midazolam n=28 Participants 0.025 mg/kg IV over 40 minutes Midazolam: 0.025 mg/kg IV over 40 minutes	Total n=55 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 2 • n=93 Participants	49 years STANDARD_DEVIATION 1 • n=4 Participants	47 years STANDARD_DEVIATION 1 • n=27 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	9 Participants n=4 Participants	14 Participants n=27 Participants
Sex: Female, Male Male	22 Participants n=93 Participants	19 Participants n=4 Participants	41 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	14 Participants n=93 Participants	20 Participants n=4 Participants	34 Participants n=27 Participants
Race (NIH/OMB) White	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) More than one race	4 Participants n=93 Participants	6 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants
Region of Enrollment United States	27 Participants n=93 Participants	28 Participants n=4 Participants	55 Participants n=27 Participants

PRIMARY outcome

Timeframe: Over the four week period following discharge from the inpatient unit at Day 5

Outcome measures

Outcome measures
Measure	Ketamine n=27 Participants 0.5 mg/kg of ketamine IV over 40 minutes Ketamine: 0.5 mg/kg IV over 40 minutes	Midazolam n=28 Participants 0.025 mg/kg IV over 40 minutes Midazolam: 0.025 mg/kg IV over 40 minutes
Number of Participants With Cocaine Use/Drop Out	16 Participants	26 Participants

PRIMARY outcome

Timeframe: Abstinence will be assessed over 4 weeks starting at the last day of week 1 and continuing through the end of study at the last day of week 5

Abstinence is defined as 2 or greater weeks of no cocaine use, as ascertained by the TLFB and urine toxicology.

Outcome measures

Outcome measures
Measure	Ketamine n=27 Participants 0.5 mg/kg of ketamine IV over 40 minutes Ketamine: 0.5 mg/kg IV over 40 minutes	Midazolam n=28 Participants 0.025 mg/kg IV over 40 minutes Midazolam: 0.025 mg/kg IV over 40 minutes
Abstinence	13 Participants	3 Participants

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Midazolam

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ketamine n=27 participants at risk 0.5 mg/kg of ketamine IV over 40 minutes Ketamine: 0.5 mg/kg IV over 40 minutes	Midazolam n=28 participants at risk 0.025 mg/kg IV over 40 minutes Midazolam: 0.025 mg/kg IV over 40 minutes
Nervous system disorders sedation	11.1% 3/27 • Number of events 3 • 5 weeks.	25.0% 7/28 • Number of events 7 • 5 weeks.

Additional Information

Elias Dakwar, MD

NYSPI

Phone: 646.774.8728

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place