Trial Outcomes & Findings for Glutamatergic Modulation of Motivation Enhancement: A Pilot Feasibility Trial (NCT NCT02373124)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

5 weeks

Results posted on

2020-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Open-label 52 minute infusion of NMDA antagonist infusion of NMDA antagonist: 52 minute infusion
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Glutamatergic Modulation of Motivation Enhancement: A Pilot Feasibility Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open-label n=4 Participants 52 minute infusion of NMDA antagonist infusion of NMDA antagonist: 52 minute infusion
Age, Continuous	50.5 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 weeks

Population: medically healthy, treatment-seeking cocaine dependent individuals without a history of abuse of or adverse reaction to ketamine or benzodiazepines.

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

Outcome measures

Outcome measures
Measure	Open-label n=4 Participants 52 minute infusion of NMDA antagonist infusion of NMDA antagonist: 52 minute infusion
Cocaine Use first choice opportunity · able to abstain	3 Participants
Cocaine Use first choice opportunity · continue to use	1 Participants
Cocaine Use second choice opportunity · able to abstain	1 Participants
Cocaine Use second choice opportunity · continue to use	0 Participants

Adverse Events

Open-label

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elias Dakwar, MD

New York State Psychiatric Institute

Phone: 6467748728

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place