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OpenTrials
Completed

NCT Number: NCT02018263

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cocaine hydrochloride

Drug

Exercise

Behavioral

nicotine

Drug

Primary outcomes

  1. Instantaneous Heart Rate and Heart Rate Variability

    Time frame: 4 weeks

Secondary outcomes

  1. Instantaneous Respiration Rate

    Time frame: 4 Weeks

  2. Hand-based/Foot-based Skin Conductance

    Time frame: 4 Weeks

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 23, 2013
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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