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Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders

NCT ID: NCT03344419

Last Updated: 2024-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Alterations in the transmission between neurons of a neurotransmitter called glutamate are an important target of pharmacotherapy for cocaine use disorders (CUDs). Preliminary investigations suggest that glutamate modulation may be effective at promoting and maintaining abstinence and that it promotes motivation to quit, reduces craving, reduces cocaine self-administration and facilitates abstinence in individuals with a CUD in a series of trials.

The study team has recently developed and tested a novel design that integrates a clinical trial involving serial infusions and a behavioral treatment platform. The current trial will evaluate the effect of two sub-anesthetic infusions on abstinence rates in a relatively large sample of treatment-seeking CUD individuals who complete a 12-week double-blind, randomized, controlled trial. It will also evaluate the correlation between clinical response and brain-derived neurotrophic factor (BDNF), a peripheral biomarker relevant to glutamate modulation antidepressant response. This project aims to expand on several years of promising preliminary data to rigorously evaluate the efficacy of this innovative pharmacological intervention integrated into a behavioral treatment platform.

Conditions

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Cocaine Use Disorder

Keywords

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cocaine mindfulness based relapse prevention motivational enhancement therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CI-581a+MET+MBRP

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

Group Type EXPERIMENTAL

CI-581a

Intervention Type DRUG

Medication infusion intravenously over 1 hour.

Motivational Enhancement Therapy (MET)

Intervention Type BEHAVIORAL

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

Mindfulness Based Relapse Prevention

Intervention Type BEHAVIORAL

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

CI-581b+MET+MBRP

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

Group Type ACTIVE_COMPARATOR

CI-581b

Intervention Type DRUG

Medication infusion intravenously over 1 hour.

Motivational Enhancement Therapy (MET)

Intervention Type BEHAVIORAL

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

Mindfulness Based Relapse Prevention

Intervention Type BEHAVIORAL

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

Interventions

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CI-581a

Medication infusion intravenously over 1 hour.

Intervention Type DRUG

CI-581b

Medication infusion intravenously over 1 hour.

Intervention Type DRUG

Motivational Enhancement Therapy (MET)

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

Intervention Type BEHAVIORAL

Mindfulness Based Relapse Prevention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Meets DSM-V criteria for cocaine use disorders, with at least 1 day of use per week for three weeks over the past month
2. Physically healthy
3. No adverse reactions to study medications
4. 18-70 years of age
5. Capacity to consent and comply with study procedures
6. Seeking Treatment

Exclusion Criteria

1. 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.
2. Physiological dependence on another substance, such as alcohol, opioids, or benzodiazepines, excluding caffeine and nicotine, requiring imminent medical management
3. Delirium, dementia, amnesia, cognitive disorders, or dissociative disorders
4. Current suicide risk or a history of suicide attempt within the 2 years
5. Pregnant, interested in becoming pregnant, or lactating
6. On psychotropic or other medication whose effect could be disrupted by participation in the study, such as benzodiazepines, opioids, or barbiturates
7. Recent history of significant violence
8. Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.
9. 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
10. 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Elias Dakwar

research psychiatrist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elias Dakwar, MD

Role: PRINCIPAL_INVESTIGATOR

NYSPI

Locations

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NYSPI

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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5U01DA040647-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

7461

Identifier Type: -

Identifier Source: org_study_id