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Infusion Laboratory: Protocol 4 (Dihydrexidine) - 13

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000348
Recruitment Status : Unknown
Verified December 2002 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Active, not recruiting
First Posted : September 21, 1999
Last Update Posted : January 11, 2017
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
The purpose of this study is to evaluate safety issues pertaining to dihydrexidine (DHX), to cocaine, and to its interaction, and to determine how pretreatment with DHX modifies the subjective as well as physiological effects of cocaine infusion.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Drug: Dihydrexidine Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 0 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Infusion Laboratory: Protocol 4 (Dihydrexidine)

Primary Outcome Measures :
  1. Degree of drug craving
  2. Frequency of IV drug use and sexual risk behaviors
  3. History, incidence and amount of drug use
  4. Type and severity of stimulant withdrawal symptoms
  5. Characterization of study population
  6. Population incidence of symptoms of depression, po
  7. Evidence of change in neurophysiology and brain ac
  8. Evidence of change in subjective responses to coca
  9. Clinical physiological response to cocaine challen
  10. Degree to which study medication influences change

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

M/F, ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000348

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United States, California
Friends Research Institute
Los Angeles, California, United States, 90025
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Walter Ling, M.D. Friends Research Institute, Inc.

Layout table for additonal information Identifier: NCT00000348     History of Changes
Other Study ID Numbers: NIDA-3-0010-13
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: December 2002

Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine dependence

Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs