Overview

Cocaine-Methylphendidate Interaction Study - 4

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Collaborator:
Cincinnati MDRU
Treatments:
Cocaine
Methylphenidate
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.