Back to resultsPemoline in the Treatment of Stimulant Dependence - 5
Primary Purpose
Cocaine-Related Disorders
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pemoline
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
Outcomes
Primary Outcome Measures
Retention
Depression
Incidence of stimulant use
Severity of stimulant withdrawal symptoms
ADHD symptom severity
Degree of drug craving
Frequency of IV drug use and sexual risk behaviors
Secondary Outcome Measures
Full Information
NCT ID
NCT00000340
First Posted
September 20, 1999
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00000340
Brief Title
Pemoline in the Treatment of Stimulant Dependence - 5
Official Title
Pemoline in the Treatment of Stimulant Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Withdrawn
Why Stopped
Study was never funded.
Study Start Date
June 1996 (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 assess the efficacy of pemoline in treating cocaine and/or methamphetamine dependent adults with comorbid Adult Attention Deficit Hyperactivity Disorder (ADHD).
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 2
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pemoline
Primary Outcome Measure Information:
Title
Retention
Title
Depression
Title
Incidence of stimulant use
Title
Severity of stimulant withdrawal symptoms
Title
ADHD symptom severity
Title
Degree of drug craving
Title
Frequency of IV drug use and sexual risk behaviors
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
12. IPD Sharing Statement
Learn more about this trial
Pemoline in the Treatment of Stimulant Dependence - 5
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