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

Completed · Phase 2

Conditions studied: Cocaine-Related Disorders

In brief

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.

Key facts

Study ID

NCT00015054

Run by

National Institute on Drug Abuse (NIDA)

People needed

20

Starts

1998-09-01

Expected to finish

1999-11-01

Last updated by the study team

2017-01-16

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

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
• Subject has a history of seizures or seizure disorder
• Subject has had an adverse reaction to methylphenidate
• Subject has abnormal thyroid function (as determined by an abnormal T4 level that is clinically significant)
• Subject has been treated for ADHD with psychomotor stimulants within the past month.
• Subject plans to receive psychosocial treatment external to that designated in the protocol during study participation.

Where it is running

• Cincinnati MDRU — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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