Overview

This trial is active, not recruiting.

Condition cocaine dependence
Treatments cocaine hydrochloride, exercise, nicotine
Sponsor Yale University
Start date October 2013
End date April 2018
Trial size 36 participants
Trial identifier NCT02018263, 1212011268

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Arm
(Experimental)
Subjects self administer cocaine hydrochloride in both laboratory and outpatient settings
exercise
nicotine
(Active Comparator)
Subjects self administer nicotine in both laboratory and outpatient settings
cocaine hydrochloride
exercise
(Active Comparator)
Subjects complete a cardiovascular exercise session in both laboratory and outpatient settings
cocaine hydrochloride
nicotine

Primary Outcomes

Measure
Instantaneous Heart Rate and Heart Rate Variability
time frame: 4 weeks

Secondary Outcomes

Measure
Instantaneous Respiration Rate
time frame: 4 Weeks
Hand-based/Foot-based Skin Conductance
time frame: 4 Weeks

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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.

Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Yale University.