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

Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT02018263
Collaborator
(none)
5
1
3
8
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Actual Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cocaine Administration

Subjects self administer cocaine hydrochloride in both laboratory and outpatient settings

Drug: Cocaine hydrochloride

Active Comparator: Nicotine Administation

Subjects self administer nicotine in both laboratory and outpatient settings

Drug: Nicotine

Active Comparator: Exercise

Subjects complete a cardiovascular exercise session in both laboratory and outpatient settings

Behavioral: Exercise

Outcome Measures

Primary Outcome Measures

  1. Instantaneous Heart Rate and Heart Rate Variability [4 weeks]

Secondary Outcome Measures

  1. Instantaneous Respiration Rate [4 Weeks]

  2. Hand-based/Foot-based Skin Conductance [4 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Connecticut Mental Health Center New Haven Connecticut United States 06519

Sponsors and Collaborators

  • Yale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gustavo Angarita, Assistant Professor of Clinical Psychiatry, Yale University
ClinicalTrials.gov Identifier:
NCT02018263
Other Study ID Numbers:
  • 1212011268
First Posted:
Dec 23, 2013
Last Update Posted:
Jun 14, 2021
Last Verified:
Feb 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 14, 2021