Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03344419 : Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders
PhasePhase 3
AgesMin: 21 Years Max: 60 Years
Eligibility
Inclusion Criteria:

1. Meets DSM-V criteria for cocaine use disorders, with at least 2 days of use per week,
or at least one weekly binge episode (>$200/occasion), over the past 30 days and
displaying at least one positive utox during screening

2. Physically healthy

3. No adverse reactions to study medications

4. 21-60 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

11. BMI > 35, or a history of unmanaged obstructive sleep apnea

12. First degree relative with a psychotic disorder (bipolar disorder with psychotic
features, schizophrenia, schizoaffective disorder, or psychosis NOS)
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03344419      |      Link to official Clinicaltrials.gov listing
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