Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158236
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-09-08
Brief Title:
Abuse Potential of Buprenorphine and Naloxone in Non-Dependent Opioid Users
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Effects of BuprenorphineNaloxone in Non-Dependent Opioid Abusers
Status:
COMPLETED
Status Verified Date:
2006-01
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 is a medication used to treat opioid addiction but individuals who use this drug are at risk of abusing it A buprenorphine and naloxone combination may reduce the likelihood of buprenorphine addiction This study will evaluate the potential for abuse of buprenorphine and a buprenorphine and naloxone combination in non-dependent opioid users
Detailed Description:
Opioid withdrawal symptoms are a major contributing factor for why opioid treatment programs often fail Individuals with severe opioid withdrawal may experience shaking muscle and bone pain nausea depression anxiety and drug craving Buprenorphine a medication that is used to treat opioid addiction works by lessening the withdrawal symptoms However past research has shown that individuals who use buprenorphine are at risk for abusing the drug Naloxone another medication is currently used to treat substance addiction It is also used in combination with buprenorphine to reduce the risk of buprenorphine abuse in individuals who are physically dependent upon opioids The purpose of this study is to compare the abuse potential of buprenorphine versus a buprenorphine and naloxone combination in non-dependent opioid users
This 7-week study will enroll non-dependent opioid users Participants will take part in two medication challenge sessions per week At each challenge session participants will be randomly assigned to receive varying doses of either buprenorphine a buprenorphine and naloxone combination hydromorphone which is a medication used to treat moderate to severe pain or placebo Buprenorphine and naloxone will be administered as tablets that are dissolved under the tongue Hydromorphone will be injected During the challenge sessions participants will complete performance tasks to measure psychomotor and cognitive functioning Questionnaires and self-reports will be completed to assess medication effects Heart rate and blood pressure will be monitored throughout all sessions and a specialized camera will be used to assess pupillary response of the eyes
This 7-week study will enroll non-dependent opioid users Participants will take part in two medication challenge sessions per week At each challenge session participants will be randomly assigned to receive varying doses of either buprenorphine a buprenorphine and naloxone combination hydromorphone which is a medication used to treat moderate to severe pain or placebo Buprenorphine and naloxone will be administered as tablets that are dissolved under the tongue Hydromorphone will be injected During the challenge sessions participants will complete performance tasks to measure psychomotor and cognitive functioning Questionnaires and self-reports will be completed to assess medication effects Heart rate and blood pressure will be monitored throughout all sessions and a specialized camera will be used to assess pupillary response of the eyes
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 |
| R01-08045-5 | None | None | None |