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

Phase 1

Completed

• Conditions: Cocaine Dependence
• Interventions: Drug: Cocaine hydrochloride; Behavioral: Exercise; Drug: Nicotine

• Registration Number: NCT02018263
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-23
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cocaine Administration	Cocaine hydrochloride	Subjects self administer cocaine hydrochloride in both laboratory and outpatient settings
Exercise	Exercise	Subjects complete a cardiovascular exercise session in both laboratory and outpatient settings
Nicotine Administation	Nicotine	Subjects self administer nicotine in both laboratory and outpatient settings

Primary Outcome Measures

Name	Time	Method
Instantaneous Heart Rate and Heart Rate Variability	4 weeks

Secondary Outcome Measures

Name	Time	Method
Hand-based/Foot-based Skin Conductance	4 Weeks
Instantaneous Respiration Rate	4 Weeks

Trial Locations

Locations (1)

Connecticut Mental Health Center; 🇺🇸 New Haven, Connecticut, United States