Recruitment

Recruitment Status
Completed
Estimated Enrollment
36

Inclusion Criterias

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

Exclusion Criterias

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

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

Exclusion Criterias

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

Locations

New Haven, Connecticut, 06519
New Haven, Connecticut, 06519

Tracking Information

NCT #
NCT02018263
Collaborators
Not Provided
Investigators
Not Provided