Infusion Laboratory: Protocol 4 (Dihydrexidine) - 13

This study is ongoing, but not recruiting participants.

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000348

Purpose

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	Intervention	Phase
Cocaine-Related Disorders	Drug: Dihydrexidine	Phase I

Drug Information available for: Dihydrexidine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Infusion Laboratory: Protocol 4 (Dihydrexidine)

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Degree of drug craving
Frequency of IV drug use and sexual risk behaviors
History, incidence and amount of drug use
Type and severity of stimulant withdrawal symptoms
Characterization of study population
Population incidence of symptoms of depression, po
Evidence of change in neurophysiology and brain ac
Evidence of change in subjective responses to coca
Clinical physiological response to cocaine challen
Degree to which study medication influences change

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	21 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000348

Locations

United States, California
Friends Research Institute
Los Angeles, California, United States, 90025

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Walter Ling, M.D.

Friends Research Institute, Inc.

More Information

Study ID Numbers:	NIDA-3-0010-13, Y01-3-0010-13
Study First Received:	September 20, 1999
Last Updated:	August 16, 2005
ClinicalTrials.gov Identifier:	NCT00000348
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Cocaine-Related Disorders
Dopamine
Dihydrexidine

Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Dopamine Agents
Dopamine Agonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009