Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 21 - 60 |
| Updated: | 12/2/2018 |
| Start Date: | October 1, 2017 |
| End Date: | April 2021 |
| Contact: | Elias Dakwar, MD |
| Email: | elias.dakwar@nyspi.columbia.edu |
| Phone: | 646-774-6117 |
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.
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.
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.
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.
Inclusion Criteria:
1. Meets DSM-V criteria for cocaine use disorders, with at least 1 day of use per week
over the past 30 days
2. Physically healthy
3. No adverse reactions to study medications
4. 21-69 years of age (including a score > 24 on the Mental Mini Status Exam for
individuals over 60 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
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 (past 2 years)
8. Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.
9. Unstable physical disorders which might make participation hazardous such as end-stage
AIDS, hypertension (>140/90), anemia, active hepatitis or other liver disease
(transaminase levels < 2-3 X the upper limit of normal will be considered acceptable),
or untreated diabetes
10. Previous history of ketamine or benzodiazepine abuse, and/or a history of adverse
reaction/experience with prior exposure to ketamine or benzodiazepines
We found this trial at
2
sites
