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

January 13, 2017 updated by: National Institute on Drug Abuse (NIDA)

MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject must be between 21 and 50 years of age, male or female, of any race.
  2. If female, subject cannot be pregnant or lactating.
  3. Subject must be cocaine-dependent (as determined by the SCID and a clinical interview by a psychiatrist).
  4. Subject must meet DSM-IV diagnostic criteria for ADHD:
  5. Subject must have been actively using cocaine, (BE>300 ng/ml) within 30 days of the screening examination.
  6. 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).
  7. Subject must be willing and able to give informed consent.

Exclusion Criteria:

  1. Subject has symptoms of AIDS.
  2. Subject has a chronic medical disorder requiring medication.
  3. Subject has a SCID Axis-I psychiatric diagnosis requiring medication.
  4. 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.
  5. Subject is in need of detoxification from alcohol or benzodiazepines
  6. Subject is taking psychotropic medication (except chloral hydrate for insomnia).
  7. 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.
  8. Subject has ALT or AST levels above three times laboratory normal
  9. Subject has renal function tests (creatinine and BUN) or electrolyte levels (K, Na, Cl, HCO3) that are not within normal limits at baseline.
  10. Subject has an EKG indicating clinically significant arrhythmias or abnormal conduction
  11. Subject has organic brain syndrome (OBS) as evidenced in the psychiatric evaluation.
  12. 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.
  13. Subject has been enrolled in another research protocol within the past 45 days.
  14. Subject has narrow angle glaucoma, by history
  15. Subject has a diagnosis or family history of Tourettes syndrome
  16. Subject has a history of seizures or seizure disorder
  17. Subject has had an adverse reaction to methylphenidate
  18. Subject has abnormal thyroid function (as determined by an abnormal T4 level that is clinically significant)
  19. Subject has been treated for ADHD with psychomotor stimulants within the past month.
  20. Subject plans to receive psychosocial treatment external to that designated in the protocol during study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Retention
Cocaine use
Global improvement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Eugene Somoza, M.D., Ph.D., Cincinnati MDRU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1998

Primary Completion (Actual)

October 1, 1999

Study Completion (Actual)

November 1, 1999

Study Registration Dates

First Submitted

April 18, 2001

First Submitted That Met QC Criteria

April 17, 2001

First Posted (Estimate)

April 18, 2001

Study Record Updates

Last Update Posted (Estimate)

January 16, 2017

Last Update Submitted That Met QC Criteria

January 13, 2017

Last Verified

February 1, 1999

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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