Recruitment

Recruitment Status
Completed
Estimated Enrollment
36

Inclusion Criteria

DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
age 18 - 50 years,
voluntary, written, informed consent,
...
DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
age 18 - 50 years,
voluntary, written, informed consent,
for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (β-HCG) test.
physically healthy by medical history, physical, neurological, ECG, and laboratory examinations,
recent street cocaine use in excess of amounts to be administered in the current study,
positive urine toxicology screen for cocaine,
intravenous and/or smoked (crack/ freebase) use,

Exclusion Criteria

Other drug dependence (except nicotine) as determined by urine toxicology or interview
a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine,
current use of any medication (prescription or over-the-counter) determined to cause potential drug interactions by the study physicians.
...
Other drug dependence (except nicotine) as determined by urine toxicology or interview
a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine,
current use of any medication (prescription or over-the-counter) determined to cause potential drug interactions by the study physicians.
a history of significant medical (cardiovascular) or neurological illness, ie prior myocardial infarction, current active symptoms of cardiovascular disease / angina, evidence of cocaine-related cardiovascular symptoms, prior arrhythmias or need for cardiov ascular resuscitation, neurovascular events such as transient ischemic attacks, stroke, and/or seizures Parameters re: elevations in vital signs are now explicitly specified under "Safety features built into our one-day self-administration paradigm).
seeking treatment for drug abuse/dependence (for experimental cocaine component),
current use of psychotropic and/or potentially psychoactive prescription medication,
< 1 year of cocaine dependence,
physical or laboratory (β-HCG) evidence of pregnancy.

Summary

Conditions
Cocaine Dependence
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Non-Randomized
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 50 years
Gender
Both males and females

Inclusion Criteria

DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
age 18 - 50 years,
voluntary, written, informed consent,
...
DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
age 18 - 50 years,
voluntary, written, informed consent,
for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (β-HCG) test.
physically healthy by medical history, physical, neurological, ECG, and laboratory examinations,
recent street cocaine use in excess of amounts to be administered in the current study,
positive urine toxicology screen for cocaine,
intravenous and/or smoked (crack/ freebase) use,

Exclusion Criteria

Other drug dependence (except nicotine) as determined by urine toxicology or interview
a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine,
current use of any medication (prescription or over-the-counter) determined to cause potential drug interactions by the study physicians.
...
Other drug dependence (except nicotine) as determined by urine toxicology or interview
a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine,
current use of any medication (prescription or over-the-counter) determined to cause potential drug interactions by the study physicians.
a history of significant medical (cardiovascular) or neurological illness, ie prior myocardial infarction, current active symptoms of cardiovascular disease / angina, evidence of cocaine-related cardiovascular symptoms, prior arrhythmias or need for cardiov ascular resuscitation, neurovascular events such as transient ischemic attacks, stroke, and/or seizures Parameters re: elevations in vital signs are now explicitly specified under "Safety features built into our one-day self-administration paradigm).
seeking treatment for drug abuse/dependence (for experimental cocaine component),
current use of psychotropic and/or potentially psychoactive prescription medication,
< 1 year of cocaine dependence,
physical or laboratory (β-HCG) evidence of pregnancy.

Tracking Information

NCT #
NCT02018263
Collaborators
Not Provided
Investigators
Not Provided
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