Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134875
Status:
TERMINATED
Last Update Posted:
2017-01-12
First Post:
2005-08-23
Brief Title:
Assessing Abuse Potential of Parenteral BuprenorphineNaloxone in Non-Dependent Opioid Abusers
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Abuse Potential of Parenteral BuprenorphineNaloxone in Non-Dependent Opioid Abusers
Status:
TERMINATED
Status Verified Date:
2008-10
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:
Buprenorphine a treatment for opioid dependence can be mixed with another drug naloxone to limit abuse potential Parenteral administration intravenous or intramuscular injection of buprenorphinenaloxone causes withdrawal symptoms in opioid dependent individuals However naloxone does not cause withdrawal symptoms in non-dependent opioid abusers This study will investigate whether naloxone decreases the opioid agonist effect from injected buprenorphine hence decreasing the abuse potential of buprenorphinenaloxone in non-dependent opioid abusers
Detailed Description:
Naloxone has been combined with buprenorphine to decrease the parenteral abuse potential of buprenorphine in opioid dependent individuals through the mechanism of naloxone-precipitated withdrawal While naloxone will not precipitate withdrawal in individuals who are not physically dependent on opioids it is possible naloxone might attenuate buprenorphines agonist effects especially if administered parenterally The purpose of this study is to assess the effect of sublingual SL and intramuscular IM buprenorphine and buprenorphinenaloxone in non-dependent opioid abusers
Participants will stay on a research ward and will undergo challenge sessions twice per week The following conditions will be tested placebo IM hydromorphone 2 and 4 mg an opioid agonist positive control condition SL buprenorphine 4 8 and 16 mg IM buprenorphine 4 8 and 16 mg SL buprenorphinenaloxone41 82 and 164 mg and IM buprenorphinenaloxone 41 82 and 164 mg During challenge sessions physiological status will be recorded continuously and tasks assessing psychomotor subjective and objective status will be performed repeatedly
Participants will stay on a research ward and will undergo challenge sessions twice per week The following conditions will be tested placebo IM hydromorphone 2 and 4 mg an opioid agonist positive control condition SL buprenorphine 4 8 and 16 mg IM buprenorphine 4 8 and 16 mg SL buprenorphinenaloxone41 82 and 164 mg and IM buprenorphinenaloxone 41 82 and 164 mg During challenge sessions physiological status will be recorded continuously and tasks assessing psychomotor subjective and objective status will be performed repeatedly
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 |
| R01-08045-3 | None | None | None |