Stress Hormones and Human Cocaine Use - 7

Cocaine-Related Disorders Clinical Trial

Official title:

Stress Hormones and Human Cocaine Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000290
• Other study ID #: NIDA-09259-7
• Secondary ID: P50-09259-7
• Status: Completed
• Phase: Phase 1
• First received: September 20, 1999
• Last updated: January 11, 2017
• Start date: May 1997
• Est. completion date: December 2001

Study information

• Verified date: November 2016
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2001
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• Cocaine

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Presented at CPDD, 6/13/99. None

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological measures
Primary	Biochemical