Back to results

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

Primary Purpose

Cocaine Dependence

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Cocaine hydrochloride

Exercise

Nicotine

About this trial

This is an interventional basic science trial for Cocaine Dependence

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Connecticut Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Cocaine Administration

Nicotine Administation

Exercise

Arm Description

Subjects self administer cocaine hydrochloride in both laboratory and outpatient settings

Subjects self administer nicotine in both laboratory and outpatient settings

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

Outcomes

Primary Outcome Measures

Instantaneous Heart Rate and Heart Rate Variability

Secondary Outcome Measures

Instantaneous Respiration Rate

Hand-based/Foot-based Skin Conductance

Full Information

NCT ID

NCT02018263

First Posted

December 17, 2013

Last Updated

February 14, 2023

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT02018263

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

October 2013 (Actual)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yale University

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine Dependence

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cocaine Administration

Arm Type

Active Comparator

Arm Description

Subjects self administer cocaine hydrochloride in both laboratory and outpatient settings

Arm Title

Nicotine Administation

Arm Type

Active Comparator

Arm Description

Subjects self administer nicotine in both laboratory and outpatient settings

Arm Title

Exercise

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cocaine hydrochloride

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Intervention Type

Drug

Intervention Name(s)

Nicotine

Primary Outcome Measure Information:

Title

Instantaneous Heart Rate and Heart Rate Variability

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Instantaneous Respiration Rate

Time Frame

4 Weeks

Title

Hand-based/Foot-based Skin Conductance

Time Frame

4 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Connecticut Mental Health Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs