Back to resultsInfusion Laboratory: Protocol 4 (Dihydrexidine) - 13
Primary Purpose
Cocaine-Related Disorders
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dihydrexidine
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring cocaine dependence
Eligibility 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.
Sites / Locations
- Friends Research Institute
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00000348
First Posted
September 20, 1999
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00000348
Brief Title
Infusion Laboratory: Protocol 4 (Dihydrexidine) - 13
Official Title
Infusion Laboratory: Protocol 4 (Dihydrexidine)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2002
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
Keywords
cocaine dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
0 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Dihydrexidine
Primary Outcome Measure Information:
Title
Degree of drug craving
Title
Frequency of IV drug use and sexual risk behaviors
Title
History, incidence and amount of drug use
Title
Type and severity of stimulant withdrawal symptoms
Title
Characterization of study population
Title
Population incidence of symptoms of depression, po
Title
Evidence of change in neurophysiology and brain ac
Title
Evidence of change in subjective responses to coca
Title
Clinical physiological response to cocaine challen
Title
Degree to which study medication influences change
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Ling, M.D.
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friends Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Infusion Laboratory: Protocol 4 (Dihydrexidine) - 13
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