Validation of a Remote Wireless Sensor Network (WSN) Approach to the Individualized Detection of Cocaine Use in Humans

Study Overview
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Brief Summary
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This study looks to explore the feasibility, sensitivity, validity, and specificity of a Remote Wireless Sensor Network (RWSN) approach to the detection of cocaine use/intoxication in the inpatient human laboratory, as well as in the outpatient setting (real world). Lastly, we look to design an algorithm for reliably detecting cocaine use in real-world settings and inference techniques for understanding the relationship between cocaine use and user contexts.

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Drug: Cocaine hydrochloride
* Behavioral: Exercise
* Drug: Nicotine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 - 50 years, voluntary, written, informed consent, physically healthy by medical history, physical, neurological, ECG, and laboratory examinations, DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20) recent street cocaine use in excess of amounts to be administered in the current study, intravenous and/or smoked (crack/ freebase) use, positive urine toxicology screen for cocaine, 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: Other drug dependence (except nicotine) as determined by urine toxicology or interview < 1 year of cocaine dependence, a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine, 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, seeking treatment for drug abuse/dependence (for experimental cocaine component), physical or laboratory (β-HCG) evidence of pregnancy. current use of any medication (prescription or over-the-counter) determined to cause potential drug interactions by the study physicians.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cocaine Administration<br>Subjects self administer cocaine hydrochloride in both laboratory and outpatient settings | Drug: Cocaine hydrochloride<br> <br> |
| Active Comparator: Nicotine Administation<br>Subjects self administer nicotine in both laboratory and outpatient settings | Drug: Nicotine<br> <br> |
| Active Comparator: Exercise<br>Subjects complete a cardiovascular exercise session in both laboratory and outpatient settings | Behavioral: Exercise<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Instantaneous Heart Rate and Heart Rate Variability |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Instantaneous Respiration Rate |  | 4 Weeks | 
| Hand-based/Foot-based Skin Conductance |  | 4 Weeks |