Stress Hormones and Human Cocaine Use - 7

Phase 1

Completed

• Conditions: Cocaine-Related Disorders

• Registration Number: NCT00000290
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

The purpose of this study is to determine the HPA axis and adrenergic system activation in response to cocaine administration.

Detailed Description

The goal of this study was to investigate the role of sympathetic-adrenal medullary (SAM) and hy0pothalamo-pituitary-adrenal (HPA) systems in mediating the addictive effects of cocaine. A toal of 6 male subjects were enrolled for this 5 day inpatient study. Subjects were assigned to either cocaine (32mg /70kg iv) or placebo (saline iv) treatment during the first experimental sessions and were crossed over to the alternative treatment during the second experimental session. Endpoints that were followed during the experimental sessions included neuroendocrine (serum epinephrine, norepinephrine and cortisol levels), physological (heart rate/blood pressure, EKG) and subjective measures (Beck Depression Inventory, Craving Questionnaire). We hypothesized that cocaine administration would lead to increased blood levels of norpinephrine, epinephrine and cortisol in cocaine dependent subjects.

Study Timeline

• Study Start: 1997-05
• Study First Submitted: 1999-09-20
• Study First Submitted QC: 1999-09-20
• Study First Posted: 1999-09-21
• Study Completion: 2001-12
• Status Verified: 2016-11
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Males between the ages of 20-45. History of smoked or intravenous cocaine use on the average of at least once a week over a 6 month period. Current history of good health and normal EKG.

Exclusion Criteria

History of suicide attempt, bipolar disorder, schizophrenia, or generalized anxiety disorder. Current problem with major depressive disorder. Current use of alcohol or other drugs on a daily basis. History of major medical illnesses. Currently on parole, probation or a legal history of violence. Treatment for chemical dependency within the past 6 months. History of sensitivity to tricyclic compounds or other prescription drugs. Use of any psychotropic drugs including MAOIs in the past 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Biochemical
Physiological measures

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States