Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134888
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-08-23
Brief Title:
Blockade Efficacy of BuprenorphineNaloxone For Opioid Dependence
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
The Acute and Protracted Blockade Efficacy of BuprenorphineNaloxone
Status:
COMPLETED
Status Verified Date:
2007-07
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:
Buprenorphine a treatment for opioid dependence can be mixed with naloxone to limit abuse potential The purpose of this study is to examine the effectiveness of buprenorphinenaloxone that is given at less than daily intervals in order to prevent withdrawal symptoms associated with stopping opioid abuse
Detailed Description:
Buprenorphine and naloxone are often combined to decrease withdrawal symptoms in opioid dependent individuals Buprenorphinenaloxone is usually given daily to individuals who are attempting to stop opioid abuse however research suggests that individuals may be more inclined to take medication if it is given in less than daily intervals The purpose of this study is to examine the opioid blockade effects of buprenorphinenaloxone that is administered in less than daily doses to opioid dependent individuals
This study will last 11 weeks Participants will stay in a residential research unit for the duration of the study Participants will be randomly assigned to receive different doses of daily sublingual buprenorphinenaloxone After a minimum of 2 weeks on each dose participants will undergo challenge sessions on each weekday for 1 week Monday through Friday Challenge sessions will consist of increasing doses of intramuscular hydromorphone During the challenge session week buprenorphinenaloxone will be given only on Monday a placebo will be given the rest of the week Challenge sessions will examine the blockade effects of buprenorphinenaloxone at 2 26 50 74 and 98 hours after the last active dose of buprenorphinenaloxone
This study will last 11 weeks Participants will stay in a residential research unit for the duration of the study Participants will be randomly assigned to receive different doses of daily sublingual buprenorphinenaloxone After a minimum of 2 weeks on each dose participants will undergo challenge sessions on each weekday for 1 week Monday through Friday Challenge sessions will consist of increasing doses of intramuscular hydromorphone During the challenge session week buprenorphinenaloxone will be given only on Monday a placebo will be given the rest of the week Challenge sessions will examine the blockade effects of buprenorphinenaloxone at 2 26 50 74 and 98 hours after the last active dose of buprenorphinenaloxone
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 |
| R01-08045-2 | None | None | None |