Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301210
Status:
COMPLETED
Last Update Posted:
2015-04-17
First Post:
2006-03-09
Brief Title:
Assessment of Tramadol as a Treatment for Opioid Addiction
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Assessment of the Level of Physical Dependence and Blockade Efficacy Produced by Tramadol
Status:
COMPLETED
Status Verified Date:
2015-04
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:
Opioids are one of the most commonly abused drugs among individuals who seek treatment for drug abuse Thus it is necessary to develop new treatments for opioid addiction The purpose of this trial is determine whether tramadol is effective in treating opioid dependent individuals
Detailed Description:
This human laboratory study will test the effects of tramadol as a step in its development as a new treatment for opioid dependence Tramadol is a moderate mu agonist opioid that may produce low levels of opioid physical dependence Tramadols capacity for producing physical dependence has not been systematically studied in humans It is important to quantify tramadol as it provides a measure of its opioid agonist effects This would also be informative in regards to the abuse liability of tramadol when used as an analgesic as currently marketed or when used in the treatment of opioid addiction as proposed in this study The purpose of this trial is to evaluate the level of physical dependence as well as blockade efficacy produced by chronic maintenance on oral tramadol in opioid dependent individuals
Participants will be randomly assigned to receive different doses of tramadol or placebo for up to six weeks Experimental sessions will take place up to three times per week during the treatment period During challenge sessions participants will receive an injection four different kinds of effects may occur in a session following this injection First no effect may occur a placebo Second an opioid agonist effect may occur opioid agonists include heroin morphine hydromorphone tramadol and methadone which may cause the participant to feel high Third an opioid antagonist effect may occur eg naloxone naltrexone which may cause the participant to feel a sense of opioid withdrawal
Participants will be randomly assigned to receive different doses of tramadol or placebo for up to six weeks Experimental sessions will take place up to three times per week during the treatment period During challenge sessions participants will receive an injection four different kinds of effects may occur in a session following this injection First no effect may occur a placebo Second an opioid agonist effect may occur opioid agonists include heroin morphine hydromorphone tramadol and methadone which may cause the participant to feel high Third an opioid antagonist effect may occur eg naloxone naltrexone which may cause the participant to feel a sense of opioid withdrawal
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 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01DA018125-02 |
| R01DA018125-02 | NIH | None | None |