Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders

Cocaine Use Disorder Clinical Trial

Official title:

Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03344419
• Other study ID #: 7461
• Secondary ID: 5U01DA040647-04
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2017
• Est. completion date: April 2024

Study information

• Verified date: May 2023
• Source: New York State Psychiatric Institute
• Contact: Elias Dakwar, MD
• Phone: 646-774-6117
• Email: elias.dakwar[@]nyspi.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Use Disorder
• Disease

Intervention

Drug:
• CI-581a
Medication infusion intravenously over 1 hour.
• CI-581b
Medication infusion intravenously over 1 hour.

Behavioral:
• Motivational Enhancement Therapy (MET)
Manualized one on one therapy aimed at mobilizing motivation for change and for goals.
• Mindfulness Based Relapse Prevention
Manualized one on one therapy aimed at mindfulness-based behavioral modification and the cultivation of relapse prevention skils.

Locations

Country	Name	City	State
United States	NYSPI	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence from Cocaine Use		from baseline to week 12