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Cocaine-Related DisordersPhase 2NCT00015054

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

A Phase 2 study testing Methylphenidate in people with Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 50 years
Conditions the study is for
Cocaine-Related Disorders
What is being tested?
Methylphenidate
How many people
20 participants
Where
1 siteUnited States
Study dates
Sep 1998to Nov 1999
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 20Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cincinnati MDRU

    Cincinnati, Ohio, 45220

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Methylphenidate
Keywords
cocaine dependence
Medical subject headings
Cocaine-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retention

  2. Cocaine use

  3. Global improvement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2001 (estimated)
  2. Study startSep 1998
  3. Primary completionOct 1999
  4. Study completionNov 1999

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
20 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00015054
Sponsor's protocol ID
NIDA-5-0012-3
Other IDs
Y01-5-0012-3
Status last verified
Feb 1999
First submitted
18 Apr 2001
Last updated
16 Jan 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Methylphenidate in people with Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00015054.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.

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