Methylphendidate Treatment of Cocaine Dependent Patients With Attention Deficit Hyperactivity Disorder - 3

NCT00015054 | Completed Phase 2

• 2 other identifiers: NIDA-5-0012-3Y01-5-0012-3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate the feasibility of methylphenidate (MPD) as effective and safe in the outpatient treatment of cocaine-dependent patients with a comorbid DSM-IV diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), to demonstrate the ability of each site to participate in a subsequent anticipated controlled trial of MPD (recruitment and execution), and to gather preliminary data on the ability of sweat patches to detect episodes of cocaine use.

Conditions

Cocaine-Related Disorders

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (3)

• Retention

• Cocaine use

• Global improvement

Interventions

Methylphenidate DRUG

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject must be between 21 and 50 years of age, male or female, of any race.
• If female, subject cannot be pregnant or lactating.
• Subject must be cocaine-dependent (as determined by the SCID and a clinical interview by a psychiatrist).
• Subject must meet DSM-IV diagnostic criteria for ADHD:
• Subject must have been actively using cocaine, (BE\>300 ng/ml) within 30 days of the screening examination.
• Subject must be negative for cocaine metabolites immediately prior to receiving a study treatment number and initial dose of MPD, as determined first by urine testing kit with result later confirmed by laboratory urine toxicology (BE \< 300 ng/ml).
• Subject must be willing and able to give informed consent.

You may not qualify if:

• Subject has symptoms of AIDS.
• Subject has a chronic medical disorder requiring medication.
• Subject has a SCID Axis-I psychiatric diagnosis requiring medication.
• Subject meets DSM-IV criteria for dependence for any substance except cocaine, alcohol, nicotine, marijuana, caffeine, and has been actively using during the past two weeks.
• Subject is in need of detoxification from alcohol or benzodiazepines
• Subject is taking psychotropic medication (except chloral hydrate for insomnia).
• Subject is female of childbearing age who is at risk for becoming pregnant and is not using adequate contraceptive techniques as determined by the evaluating physician or Principal Investigator.
• Subject has ALT or AST levels above three times laboratory normal
• Subject has renal function tests (creatinine and BUN) or electrolyte levels (K, Na, Cl, HCO3) that are not within normal limits at baseline.
• Subject has an EKG indicating clinically significant arrhythmias or abnormal conduction
• Subject has organic brain syndrome (OBS) as evidenced in the psychiatric evaluation.
• Subject has an acute or chronic medical or psychiatric condition which in the judgment of the evaluating physician would make study participation difficult or unsafe.
• Subject has been enrolled in another research protocol within the past 45 days.
• Subject has narrow angle glaucoma, by history
• Subject has a diagnosis or family history of Tourettes syndrome

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead
• Cincinnati MDRU: collaborator

Study Sites (1)

Cincinnati MDRU

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Eugene Somoza, M.D., Ph.D.

  Cincinnati MDRU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 18, 2001
• First Posted: April 18, 2001
• Study Start: September 1, 1998
• Primary Completion: October 1, 1999
• Study Completion: November 1, 1999
• Last Updated: January 16, 2017

Record last verified: 1999-02

Locations

US (1)