NCT00015223

Brief Summary

The purpose of this study is the use of Methylphenidate in the treatment of cocaine dependence and Attention Deficit Hyperactivity Disorder (ADHD) comorbidity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 1997

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1997

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 1999

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 1999

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 18, 2001

Completed
Last Updated

January 16, 2017

Status Verified

October 1, 2012

Enrollment Period

2.1 years

First QC Date

April 18, 2001

Last Update Submit

January 13, 2017

Conditions

Cocaine-Related DisordersSubstance-Related Disorders

Outcome Measures

Primary Outcomes (4)

  • Cocaine use

  • Methylphenidate retention

  • Safety assessments

  • Psychosocial counseling sessions

Interventions

MethylphenidateDRUG

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Cocaine-dependent. Meets the DSM-IV criteria for ADHD. Actively using cocaine within the past 30 days of screening.

You may not qualify if:

  • Symptoms of AIDS. Significant medical disorder. DSM-IV criteria for any substance other than cocaine, alcohol, nicotine, marijuana, caffeine. Requires detoxification from ETOH or benzos. History of seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati MDRU

Cincinnati, Ohio, United States

Location

MeSH Terms

Conditions

Cocaine-Related DisordersSubstance-Related Disorders

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gene Somoza, M.D.

    U of Cincinnati

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

April 18, 2001

First Posted

April 18, 2001

Study Start

June 1, 1997

Primary Completion

July 1, 1999

Study Completion

August 1, 1999

Last Updated

January 16, 2017

Record last verified: 2012-10

Locations

US(1)