Stress Hormones and Human Cocaine Use - 7 - Tabular View

Tracking Information

First Received Date ^ICMJE

September 20, 1999

Last Updated Date

November 3, 2005

Start Date ^ICMJE

May 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Physiological measures
Biochemical

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00000290 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Stress Hormones and Human Cocaine Use - 7

Official Title ^ICMJE

Stress Hormones and Human Cocaine Use

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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Double-Blind, Placebo Control, Crossover Assignment

Condition ^ICMJE

Cocaine-Related Disorders

Intervention ^ICMJE

Drug: Cocaine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2001

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

20 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000290

Responsible Party

Study ID Numbers ^ICMJE

NIDA-09259-7, P50-09259-7

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

University of Minnesota

Investigators ^ICMJE

Principal Investigator:

Dorothy Hatsukami, Ph.D.

University of Minnesota

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

January 1998

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP