Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders

NCT03344419 | Suspended Phase 3 DMC FDA Drug

• 2 other identifiers: 74615U01DA040647-04
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Changes in the communication of glutamate from one brain structure to another are important in the development of therapy for cocaine use disorders. Our preliminary investigations suggest that drugs that affect glutamate exchange may be effective at promoting and maintaining individuals' abstinence from cocaine. The purpose of this randomized, double-blind, controlled trial is to test various glutamate modulators in conjunction with motivational enhancement therapy (MET) and mindfulness based relapse prevention (MBRP) for cocaine use disorders.

Conditions

Cocaine Use Disorder

Keywords

cocaine; mindfulness based relapse prevention; motivational enhancement therapy

Outcome Measures

Primary Outcomes (1)

• Abstinence from Cocaine Use

  from baseline to week 12

Study Arms (2)

CI-581a+MET+MBRP

EXPERIMENTAL

Administration of CI-581a at 0.71 mg/kg during weeks 1 and 5 combined with a 12-week course in MET and MBRP

Drug: CI-581a; Behavioral: Motivational Enhancement Therapy (MET); Behavioral: Mindfulness Based Relapse Prevention

CI-581b+MET+MBRP

ACTIVE COMPARATOR

Administration of CI-581b at 0.025 mg/kg during weeks 1 and 5 combined with a 12-week course in MET and MBRP

Drug: CI-581b; Behavioral: Motivational Enhancement Therapy (MET); Behavioral: Mindfulness Based Relapse Prevention

Interventions

CI-581a DRUG

Medication infusion intravenously over 1 hour.

CI-581a+MET+MBRP

CI-581b DRUG

Medication infusion intravenously over 1 hour.

CI-581b+MET+MBRP

Motivational Enhancement Therapy (MET) BEHAVIORAL

Manualized one on one therapy aimed at mobilizing motivation for change and for goals.

CI-581a+MET+MBRP; CI-581b+MET+MBRP

Mindfulness Based Relapse Prevention BEHAVIORAL

Manualized one on one therapy aimed at mindfulness-based behavioral modification and the cultivation of relapse prevention skils.

CI-581a+MET+MBRP; CI-581b+MET+MBRP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets DSM-V criteria for cocaine use disorders, with at least 1 day of use per week for three weeks over the past month
• Physically healthy
• No adverse reactions to study medications
• years of age
• Capacity to consent and comply with study procedures
• Seeking Treatment

You may not qualify if:

• 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 and nicotine, requiring imminent medical management
• Delirium, dementia, amnesia, cognitive disorders, or dissociative disorders
• Current suicide risk or a history of suicide attempt within the 2 years
• Pregnant, interested in becoming pregnant, or lactating
• On psychotropic or other medication whose effect could be disrupted by participation in the study, such as benzodiazepines, opioids, or barbiturates
• Recent history of significant violence
• Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.
• Unstable physical disorders which might make participation hazardous such as hypertension (\>160/90), anemia, active hepatitis or other liver disease (transaminase levels \< 2-3 X the upper limit of normal will be considered acceptable), or untreated diabetes. Participants reporting HIV+ status will be asked to provide information about their current treatment, including all medications. Participants who are on the antiretroviral ritonavir (Norvir) will be excluded due to the possibility that study medications in combination with this medication may increase the risk of drug-induced hepatitis
• Previous history of a substance use disorder with the study medications or benzodiazepine abuse and/or a history of adverse reaction/ experience with prior exposure to study medications or benzodiazepines

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

NYSPI

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Elias Dakwar, MD

  NYSPI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research psychiatrist

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 17, 2017
• Study Start: October 1, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

US (1)