Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00124696
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-07-22
Brief Title:
Cocaethylene as a Treatment for Cocaine Dependence - 1
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Cocaethylene Substitution Therapy and Tolerance Induction in Treating Cocaine Dependence
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cocaine has been cited as the primary drug threat in the United States The purpose of this study is to determine if cocaethylene used as a prototype drug is a safe and effective treatment for cocaine dependence
Detailed Description:
Currently there are no medications available to specifically treat cocaine addiction Cocaethylene is an active metabolite of cocaine and has a similar chemical structure to cocaine The purpose of this study is to determine whether substitution therapy with cocaethylene is a safe and effective treatment for cocaine dependence
This double-blind placebo-controlled trial will occur in 3 parts In Part 1 the individual pharmacokinetics of an intravenous dose of cocaethylene will be determined in order to estimate individualized cocaethylene infusion rates and pharmacokinetic parameters This will provide important information on how cocaethylene is processed by the body In Part 2 an infusion of cocaethylene producing a venous plasma concentration of 200 ngml will be administered over an 8-hour period Clinical monitoring and blood sampling will occur in order to determine the safety profile of cocaethylene During Part 3 the ability of cocaethylene to modify the acute effects of intravenous cocaine will be determined Cocaethylene will be administered in plasma concentrations of 0 ngml 50 ngml or 200 ngml over an 8-hour period Participants will be randomly assigned to receive a challenge intravenous dose of cocaine 05 mgkg or 1 mgkg or placebo at the 4-hour mark of cocaethylene infusion Following the initial 8-hour period cocaethylene infusion will be continued for an additional 5 hours Behavioral and physiological measures will be collected throughout the study sessions at predetermined times to evaluate whether tolerance to cocaethylene develops These measures will also help to determine whether cocaethylene modifies or produces tolerance to the effects of an acute dose of cocaine
This double-blind placebo-controlled trial will occur in 3 parts In Part 1 the individual pharmacokinetics of an intravenous dose of cocaethylene will be determined in order to estimate individualized cocaethylene infusion rates and pharmacokinetic parameters This will provide important information on how cocaethylene is processed by the body In Part 2 an infusion of cocaethylene producing a venous plasma concentration of 200 ngml will be administered over an 8-hour period Clinical monitoring and blood sampling will occur in order to determine the safety profile of cocaethylene During Part 3 the ability of cocaethylene to modify the acute effects of intravenous cocaine will be determined Cocaethylene will be administered in plasma concentrations of 0 ngml 50 ngml or 200 ngml over an 8-hour period Participants will be randomly assigned to receive a challenge intravenous dose of cocaine 05 mgkg or 1 mgkg or placebo at the 4-hour mark of cocaethylene infusion Following the initial 8-hour period cocaethylene infusion will be continued for an additional 5 hours Behavioral and physiological measures will be collected throughout the study sessions at predetermined times to evaluate whether tolerance to cocaethylene develops These measures will also help to determine whether cocaethylene modifies or produces tolerance to the effects of an acute dose of cocaine
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 |
|---|---|---|---|
| DPMC | None | None | None |
| R01-13586-1 | None | None | None |