Recruitment

Recruitment Status
Completed
Estimated Enrollment
36

Inclusion Criteria

intravenous and/or smoked (crack/ freebase) use,
age 18 - 50 years,
recent street cocaine use in excess of amounts to be administered in the current study,
...
intravenous and/or smoked (crack/ freebase) use,
age 18 - 50 years,
recent street cocaine use in excess of amounts to be administered in the current study,
voluntary, written, informed consent,
physically healthy by medical history, physical, neurological, ECG, and laboratory examinations,
positive urine toxicology screen for cocaine,
DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
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.

Exclusion Criteria

seeking treatment for drug abuse/dependence (for experimental cocaine component),
Other drug dependence (except nicotine) as determined by urine toxicology or interview
< 1 year of cocaine dependence,
...
seeking treatment for drug abuse/dependence (for experimental cocaine component),
Other drug dependence (except nicotine) as determined by urine toxicology or interview
< 1 year of cocaine dependence,
physical or laboratory (β-HCG) evidence of pregnancy.
a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine,
current use of psychotropic and/or potentially psychoactive prescription medication,
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).
current use of any medication (prescription or over-the-counter) determined to cause potential drug interactions by the study physicians.

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

intravenous and/or smoked (crack/ freebase) use,
age 18 - 50 years,
recent street cocaine use in excess of amounts to be administered in the current study,
...
intravenous and/or smoked (crack/ freebase) use,
age 18 - 50 years,
recent street cocaine use in excess of amounts to be administered in the current study,
voluntary, written, informed consent,
physically healthy by medical history, physical, neurological, ECG, and laboratory examinations,
positive urine toxicology screen for cocaine,
DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
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.

Exclusion Criteria

seeking treatment for drug abuse/dependence (for experimental cocaine component),
Other drug dependence (except nicotine) as determined by urine toxicology or interview
< 1 year of cocaine dependence,
...
seeking treatment for drug abuse/dependence (for experimental cocaine component),
Other drug dependence (except nicotine) as determined by urine toxicology or interview
< 1 year of cocaine dependence,
physical or laboratory (β-HCG) evidence of pregnancy.
a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine,
current use of psychotropic and/or potentially psychoactive prescription medication,
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).
current use of any medication (prescription or over-the-counter) determined to cause potential drug interactions by the study physicians.

Tracking Information

NCT #
NCT02018263
Collaborators
Not Provided
Investigators
Not Provided
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