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Completed

NCT Number: NCT00000290

Stress Hormones and Human Cocaine Use - 7

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

Completed

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Key information

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cocaine

Drug

Primary outcomes

  1. Physiological measures

  2. Biochemical

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Collaborators

  • University of Minnesota

Registry information

Official study title

Stress Hormones and Human Cocaine Use

Important dates

Study start
1997
Study completion
2001
First posted
Sep 21, 1999
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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