Validation of a Remote Wireless Sensor Network (WSN) Approach to the Individualized Detection of Cocaine Use in Humans
Last updated on April 2022Recruitment
- 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