Ignite Creation Date:
2024-05-06 @ 12:42 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01631383
Status:
COMPLETED
Last Update Posted:
2019-09-27
First Post:
2012-06-18
Brief Title:
Pharmacokinetic and Safety Evaluation of L-tetrahydropalmatine l-THP With Cocaine Exposure in People With a History of Cocaine Use
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Pharmacokinetic and Safety Evaluation of L-tetrahydropalmatine l-THP With Cocaine Exposure in People With a History of Cocaine Use
Status:
COMPLETED
Status Verified Date:
2019-09
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:
This study will test the safety and pharmacokinetic profile of l-THP with cocaine exposure in people who have a history of cocaine use The subject will be admitted to the Brief Stay Unit BSU an inpatient facility at the Maryland Psychiatric Research Center used for short term drug abuse or clinical trial studies The participant will stay for 4 nights and 5 days Heshe will be randomized to either placebo or l-THP for three days On the morning of Day 4 the subject will receive one cocaine dose 40 mg intranasal and have testing for pharmacokinetic parameters for the following 10 hours The subject will stay over one more night and will be discharged the following day Approximately 40 subjects will be randomized to enroll the target sample of 30 N15 placebo N15 l-THP In summary each subject will come for a screening visits then a 5-day 4-night stay on a secure research unit After cocaine administration day the participant will stay overnight for one more day of observation and to permit substantial l-THP elimination from the body The following morning we will get one additional blood specimen for l-THP Day 5 at 24 hours after last dose 730 am then the participant will be discharged A visit with blood collection on Day 6 at 55 hours after last dose 230 pm will be scheduled A final follow-up visit will be scheduled 4-7 days after unit discharge to ensure no persisting side effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1DP1DA031401-01 | NIH | None | httpsreporternihgovquickSearch1DP1DA031401-01 |