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

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	Cincinnati MDRU
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00015054

Purpose

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.

Condition	Intervention	Phase
Cocaine-Related Disorders	Drug: Methylphenidate	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Cocaine hydrochloride Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Retention
Cocaine use
Global improvement

Estimated Enrollment:	20
Study Start Date:	September 1998

Detailed Description:

Forty-one participants were enrolled into this multi-site, outpatient, open-label, ten-week trial. Participants were scheduled to attend three visits per week to allow safety and efficacy measures to be taken. In addition, participants were given two hours of individual substance abuse therapy during the first four weeks, and one hour per week during the last six weeks, of the trial. All participants were started on a total daily dose of 20 mg MPD. The total daily dose was then increased to a maximum daily dose of 60 mg (20 mg TID) or to the maximum dose tolerated by the participant.

Eligibility

Ages Eligible for Study:	21 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00015054

Locations

United States, Ohio
Cincinnati MDRU
Cincinnati, Ohio, United States, 45220

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Cincinnati MDRU

Investigators

Principal Investigator:

Eugene Somoza, M.D., Ph.D.

Cincinnati MDRU

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00015054 History of Changes
Other Study ID Numbers:	NIDA-5-0012-3, Y01-5-0012-3
Study First Received:	April 18, 2001
Last Updated:	November 3, 2005
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Cocaine-Related Disorders
Attention Deficit Disorder with Hyperactivity
Substance-Related Disorders
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012