Pemoline in the Treatment of Stimulant Dependence - 5

Cocaine-Related Disorders Clinical Trial

Official title:

Pemoline in the Treatment of Stimulant Dependence

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00000340
• Other study ID #: NIDA-3-0010-5
• Secondary ID: Y01-3-0010-5
• Status: Withdrawn
• Phase: Phase 2
• First received: September 20, 1999
• Last updated: January 11, 2017
• Start date: June 1996

Study information

• Verified date: August 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• Pemoline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention
Primary	Depression
Primary	Incidence of stimulant use
Primary	Severity of stimulant withdrawal symptoms
Primary	ADHD symptom severity
Primary	Degree of drug craving
Primary	Frequency of IV drug use and sexual risk behaviors