NCT00015067

Brief Summary

The purpose of this study is to attempt to identify possible dangerous interactions between cocaine and methylphenidate (MPD). Additional objectives are to determine: a) if MPD reduces the craving and high for cocaine; b) if there are pharmacokinetic and pharmacodynamic interactions between cocaine and MPD; and c) the relationship between cocaine and benzoylecgonine (BE) levels in plasma and BE levels in urine.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1997

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 18, 2001

Completed
Last Updated

January 12, 2017

Status Verified

October 1, 1998

First QC Date

April 18, 2001

Last Update Submit

January 11, 2017

Conditions

Cocaine-Related Disorders

Outcome Measures

Primary Outcomes (3)

  • Cocaine withdrawal

  • Hemodynamic response to cocaine before and after MPD administrtation

  • Cocaine related high

Interventions

MethylphenidateDRUG

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • male or female of any race, between 21 and 45 years of age.
  • cocaine dependent according to DSM-IV criteria.
  • currently use cocaine by smoked or intravenous route of administration and confirmed by positive urine screen for benzoylecgonine within 2 weeks prior to signing the informed consent form. The subjects who currently use cocaine by smoked route must have a history of intravenous exposure to drugs of abuse.
  • in stable physical and mental health as judged by interview and physical examinations.
  • for female subjects, test non-pregnant and use adequate birth control. All female subjects will have a serum pregnancy test performed prior to the first dose of study medication.
  • be capable of providing written informed consent to participate in this study.
  • able to comply with protocol requirements and be likely to complete all study treatments.
  • within 20% of ideal body weight.

You may not qualify if:

  • require detoxification from alcohol, opiates, or sedative-hypnotics.
  • have a history of significant hepatic, renal, endocrine, cardiac (i.e., arrhythmia requiring medication, angina pectoris, myocardial infarction), stroke, seizure, neurological, non-drug-related psychiatric, gastrointestinal, pulmonary, hematological or metabolic disorders.
  • have a history of adverse reaction to cocaine including loss of consciousness, chest pain, psychosis, or seizure.
  • have a history of adverse reaction/hypersensitivity to methylphenidate.
  • test positive upon urine toxicology screen for opiates, benzodiazepines, barbiturates or related CNS depressants, amphetamines or related stimulants.
  • have clinically significant abnormal laboratory measurements in liver function tests (AST and ALT levels greater than 3 times of the upper limit of normal), hematology (CBC, differential, platelet count), serum chemistries (SMA-24) and EKG.
  • have any significant active medical, or psychiatric illness which might inhibit their ability to complete the study or might be complicated by administration of the test drug.
  • have active hypertension as defined by the American Heart Association criteria.
  • currently receive any medications for the treatment of any significant medical conditions.
  • have a history of glaucoma.
  • have a diagnosis or family history of Tourettes syndrome.
  • have an abnormal thyroid function (as determined by an abnormal T4 level).
  • have a history of seizures or seizure disorder.
  • have any medical history or condition considered by the investigator(s) to place the subjects at increased risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati MDRU

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Eugene Somoza, M.D., Ph.D.

    Cincinnati MDRU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

April 18, 2001

First Posted

April 18, 2001

Study Start

December 1, 1997

Last Updated

January 12, 2017

Record last verified: 1998-10

Locations

US(1)