Validation of a Remote Wireless Sensor Network (WSN) Approach to the Individualized Detection of Cocaine Use in Humans
This trial is active, not recruiting.
|Treatments||cocaine hydrochloride, exercise, nicotine|
|Start date||October 2013|
|End date||April 2018|
|Trial size||36 participants|
|Trial identifier||NCT02018263, 1212011268|
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.
|Intervention model||single group assignment|
Instantaneous Heart Rate and Heart Rate Variability
time frame: 4 weeks
Instantaneous Respiration Rate
time frame: 4 Weeks
Hand-based/Foot-based Skin Conductance
time frame: 4 Weeks
Male or female participants from 18 years up to 50 years old.
Inclusion Criteria: 1. age 18 - 50 years, 2. voluntary, written, informed consent, 3. physically healthy by medical history, physical, neurological, ECG, and laboratory examinations, 4. DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20) 5. recent street cocaine use in excess of amounts to be administered in the current study, 6. intravenous and/or smoked (crack/ freebase) use, 7. positive urine toxicology screen for cocaine, 8. 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: 1. Other drug dependence (except nicotine) as determined by urine toxicology or interview 2. < 1 year of cocaine dependence, 3. a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine, 4. 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). 5. current use of psychotropic and/or potentially psychoactive prescription medication, 6. seeking treatment for drug abuse/dependence (for experimental cocaine component), 7. physical or laboratory (β-HCG) evidence of pregnancy. 8. current use of any medication (prescription or over-the-counter) determined to cause potential drug interactions by the study physicians.
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