Status:
SUSPENDED
Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Use Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 t...
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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
- 18-70 years of age
- Capacity to consent and comply with study procedures
- Seeking Treatment
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03344419
Start Date
October 1 2017
End Date
December 31 2024
Last Update
July 16 2024
Active Locations (1)
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1
NYSPI
New York, New York, United States, 10032