Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499746
Status:
COMPLETED
Last Update Posted:
2017-10-17
First Post:
2007-07-09
Brief Title:
The Discriminative Effects of Tramadol in Humans
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Medications Development for Drug Abuse Disorders
Status:
COMPLETED
Status Verified Date:
2017-09
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:
This research is part of a set of studies whose purpose is to test whether tramadol can be used for the treatment of opioid addiction Tramadol is already available in the United States as a pain medicine marketed as Ultram It has effects similar to morphine and it may also have effects similar to other drugs like stimulants The doses of tramadol used in this study are higher than those generally used for the treatment of pain To be in this study a participant must be a user of opioids drugs like heroin and stimulants drugs like cocaine but cannot be addicted to either The person must be between 21-55 years old and generally healthy Up to 12 people will take part in this study
Detailed Description:
This is a human laboratory study that tests the effects of tramadol as a step in the possible development of this medication as a new treatment for opioid dependence Tramadol is a mildmoderate mu agonist opioid currently marketed as an analgesic that has a unique profile of effects One of the primary metabolites of tramadol mono-O-demethyltramadol referred to as M1 exerts opioid agonist effects at the mu receptor In addition tramadol and M1 produce reuptake blockade of monoamines and this latter effect may positively influence its analgesic efficacy in addition to influencing the subjective effects produced by tramadol Preclinical evidence suggests that tramadols effects on monoamine reuptake may have antidepressant qualities as well Given tramadols diverse pharmacodynamic profile a systematic characterization of its subjective effects in opioid-experienced subjects would provide valuable information regarding its abuse liability and its potential utility as a treatment for opioid dependence
The characterization of an opioid medications profile can be accomplished through a variety of experimental procedures One useful procedure for assessing the profile of an opioid is a drug discrimination procedure In this methodology subjects are first trained to discriminate reference drugs such as placebo and an opioid agonist and then administered doses of a novel compound to determine how like or unlike it is to the reference training conditions Our laboratory has a long history of using this drug discrimination methodology to study and to characterize opioids with varying opioid receptor activity profiles Studies have generally included either two or three training conditions in humans Using this technique in volunteers studies have characterized the profile of a number of opioids including for example butorphanol nalbuphine pentazocine and buprenorphine
While most of these studies testing the effects of mixed agonist-antagonist opioids have used an opioid agonist and placebo as the training conditions tramadols profile of effects suggests that there may be a non-opioid component of action at serotonin and norepinephrine sites that will be useful to distinguish In particular it is of interest to determine the extent to which tramadol is identified as being like a prototypic mu agonist opioid whether it is substantially identified as being like a non-opioid compound and if this non-opioid component is related to enhancement of monoamine effects In order to provide a meaningful non-opioid contrast training condition this study will compare different doses of tramadol to training conditions of placebo a mu agonist opioid and a prototypic stimulant
Overall this evaluation will provide a greater understanding of the subjective effect profile of tramadol in comparison to a prototypic mu opioid and a prototypic stimulant If tramadol is to be useful in the treatment of opioid dependence a thorough assessment of its subjective effects in experienced opioid and stimulant abusers is warranted
The characterization of an opioid medications profile can be accomplished through a variety of experimental procedures One useful procedure for assessing the profile of an opioid is a drug discrimination procedure In this methodology subjects are first trained to discriminate reference drugs such as placebo and an opioid agonist and then administered doses of a novel compound to determine how like or unlike it is to the reference training conditions Our laboratory has a long history of using this drug discrimination methodology to study and to characterize opioids with varying opioid receptor activity profiles Studies have generally included either two or three training conditions in humans Using this technique in volunteers studies have characterized the profile of a number of opioids including for example butorphanol nalbuphine pentazocine and buprenorphine
While most of these studies testing the effects of mixed agonist-antagonist opioids have used an opioid agonist and placebo as the training conditions tramadols profile of effects suggests that there may be a non-opioid component of action at serotonin and norepinephrine sites that will be useful to distinguish In particular it is of interest to determine the extent to which tramadol is identified as being like a prototypic mu agonist opioid whether it is substantially identified as being like a non-opioid compound and if this non-opioid component is related to enhancement of monoamine effects In order to provide a meaningful non-opioid contrast training condition this study will compare different doses of tramadol to training conditions of placebo a mu agonist opioid and a prototypic stimulant
Overall this evaluation will provide a greater understanding of the subjective effect profile of tramadol in comparison to a prototypic mu opioid and a prototypic stimulant If tramadol is to be useful in the treatment of opioid dependence a thorough assessment of its subjective effects in experienced opioid and stimulant abusers is warranted
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 |
|---|---|---|---|
| DPMCDA | OTHER | NIDA | httpsreporternihgovquickSearchR01DA018125 |
| R01DA018125 | NIH | None | None |