Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015067
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2001-04-18
Brief Title:
Cocaine-Methylphendidate Interaction Study - 4
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Cocaine-Methylphendidate Interaction Study
Status:
COMPLETED
Status Verified Date:
1998-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 p00001 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 143min 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Y01-5-0012-4 | None | None | None |