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Cocaine-Methylphendidate Interaction Study - 4

This study has been completed.
Sponsor:
Collaborator:
Cincinnati MDRU
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00015067
First received: April 18, 2001
Last updated: November 3, 2005
Last verified: October 1998
  Purpose

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.


Condition Intervention Phase
Cocaine-Related Disorders
Drug: Methylphenidate
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Official Title: Cocaine-Methylphendidate Interaction Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Cocaine withdrawal
  • Hemodynamic response to cocaine before and after MPD administrtation
  • Cocaine related high

Estimated Enrollment: 8
Study Start Date: December 1997
Detailed Description:

This study was conducted to evaluate the cardiovascular risk of prescribing up to 90 mg of methylphenidate (MPD) daily for treating cocaine dependence. This within-subject study was completed in an inpatient setting. It was non-blinded for MPD dose and single-blinded for cocaine dose. Each patient was given intravenous cocaine at 0, 20 and 40 mg while at three different steady state levels of MPD (0, 60 and 90 mg). Seven non-treatment seeking cocaine addicts, who were recruited from the community, completed the study. There were no cardiac rhythm abnormalities noted except for sinus tachycardia and sinus bradycardia. There were no incidences of seizures or myocardial ischemia. In a repeated measures ANOVA, MPD was shown to have an independent positive effect on heart rate (p=0.0001) but not on SBP or DBP. There was no cocaine by MPD interaction for any vital sign. Peak systolic blood pressure (SBP) and diastolic blood pressure (DBP) for any patient up to 60 minutes after infusion was 169 mm and 108 mm, respectively. The first occurred when 60 mg of MPD and placebo cocaine were given and the second when no MPD and placebo cocaine were given. Peak heart rate for any patient up to 60 min after infusion was 143/min at 60 mg of MPD and 40mg of cocaine. The number of adverse events reported when cocaine and MPD were given together was less than the number reported when either drug was given alone. The adverse events reported when cocaine and MPD were given together included headache, nervousness, and lightheadedness. Subjective ratings of drug effect revealed that MPD did not enhance patients' response to, or desire for, cocaine. MPD appears to be a safe drug to use in cocaine addicts who continue to use cocaine at the dosages tested.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. male or female of any race, between 21 and 45 years of age.
  2. cocaine dependent according to DSM-IV criteria.
  3. 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.
  4. in stable physical and mental health as judged by interview and physical examinations.
  5. 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.
  6. be capable of providing written informed consent to participate in this study.
  7. able to comply with protocol requirements and be likely to complete all study treatments.
  8. within 20% of ideal body weight.

Exclusion Criteria:

  1. require detoxification from alcohol, opiates, or sedative-hypnotics.
  2. 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.
  3. have a history of adverse reaction to cocaine including loss of consciousness, chest pain, psychosis, or seizure.
  4. have a history of adverse reaction/hypersensitivity to methylphenidate.
  5. test positive upon urine toxicology screen for opiates, benzodiazepines, barbiturates or related CNS depressants, amphetamines or related stimulants.
  6. 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.
  7. 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.
  8. have active hypertension as defined by the American Heart Association criteria.
  9. currently receive any medications for the treatment of any significant medical conditions.
  10. have a history of glaucoma.
  11. have a diagnosis or family history of Tourettes syndrome.
  12. have an abnormal thyroid function (as determined by an abnormal T4 level).
  13. have a history of seizures or seizure disorder.
  14. have any medical history or condition considered by the investigator(s) to place the subjects at increased risk.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00015067

Locations
United States, Ohio
Cincinnati MDRU
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
Cincinnati MDRU
Investigators
Principal Investigator: Eugene Somoza, M.D., Ph.D. Cincinnati MDRU
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00015067     History of Changes
Other Study ID Numbers: NIDA-5-0012-4, Y01-5-0012-4
Study First Received: April 18, 2001
Last Updated: November 3, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cocaine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Methylphenidate
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014