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

NCT02018263 | Completed Phase 1

• 1 other identifier: 1212011268
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence

Outcome Measures

Primary Outcomes (1)

• Instantaneous Heart Rate and Heart Rate Variability

  4 weeks

Secondary Outcomes (2)

• Instantaneous Respiration Rate

  4 Weeks

• Hand-based/Foot-based Skin Conductance

  4 Weeks

Study Arms (3)

Cocaine Administration

ACTIVE COMPARATOR

Subjects self administer cocaine hydrochloride in both laboratory and outpatient settings

Drug: Cocaine hydrochloride

Nicotine Administation

ACTIVE COMPARATOR

Subjects self administer nicotine in both laboratory and outpatient settings

Drug: Nicotine

Exercise

ACTIVE COMPARATOR

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

Behavioral: Exercise

Interventions

Cocaine hydrochloride DRUG

Cocaine Administration

Exercise BEHAVIORAL

Exercise

Nicotine DRUG

Nicotine Administation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Cocaine; Exercise; Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Solanaceous Alkaloids; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 23, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

US (1)