Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134914
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-08-23
Brief Title:
Effects of BuprenorphineNaloxone Administered in Different Ways For Treating Opioid Dependence
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Effects of BuprenorphineNaloxone in Treating Opioid Dependent Individuals
Status:
COMPLETED
Status Verified Date:
2008-07
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:
Buprenorphine is a treatment for opioid dependence Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine The purpose of this study is to examine the effects of buprenorphinenaloxone when given through different routes and at different doses
Detailed Description:
Buprenorphine a mixed agonist-antagonist opioid or partial agonist is a safe and effective treatment for opioid dependence However there is concern that buprenorphine may be abused due to its high abuse potential A sublingual buprenorphinenaloxone combination tablet may reduce the risk of abuse associated with buprenorphine alone The purpose of this study is to characterize the effects of buprenorphinenaloxone in opioid-dependent individuals
This study will last 10 weeks Participants will stay in a residential research unit and will be maintained on oral hydromorphone 10 mg During twice-weekly experimental sessions participants will be randomly assigned to receive either sublingual tablets intramuscular injections or a placebo The 15 conditions studied will include sublingual or intramuscular buprenorphinenaloxone 1025 mg 205 mg 41 mg 82 mg and 164 mg 025 mg of intramuscular naloxone antagonist control 10 mg of intramuscular hydromorphone agonist control sublingual and intramuscular buprenorphine 8 mg and placebo
This study will last 10 weeks Participants will stay in a residential research unit and will be maintained on oral hydromorphone 10 mg During twice-weekly experimental sessions participants will be randomly assigned to receive either sublingual tablets intramuscular injections or a placebo The 15 conditions studied will include sublingual or intramuscular buprenorphinenaloxone 1025 mg 205 mg 41 mg 82 mg and 164 mg 025 mg of intramuscular naloxone antagonist control 10 mg of intramuscular hydromorphone agonist control sublingual and intramuscular buprenorphine 8 mg and placebo
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 |
| R01-08045-4 | None | None | None |