Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142896
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-09-01
Brief Title:
Tramadol to Reduce Opioid Withdrawal Symptoms
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Withdrawal Suppression Efficacy of Tramadol
Status:
COMPLETED
Status Verified Date:
2008-08
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:
Individuals with opioid addiction often experience serious withdrawal symptoms that may make relapse unavoidable Tramadol a medication that is currently used to treat pain caused by chronic conditions such as cancer or joint pain may also be effective at reducing opioid withdrawal symptoms This study will evaluate the effectiveness of tramadol at reducing withdrawal symptoms in individuals addicted to opioid drugs
Detailed Description:
Opioid withdrawal symptoms are a major contributing factor for why opioid treatment programs often fail Individuals with severe opioid withdrawal symptoms may experience shaking muscle and bone pain nausea depression anxiety and drug craving Tramadol is a medication that is currently used to treat moderate to severe pain in individuals with cancer joint pain or pain resulting from surgery Because of its pharmacological profile tramadol may also be useful in treating opioid withdrawal Further research is needed to confirm the benefits of tramadol for opioid addicts The purpose of this study is to evaluate the effectiveness of tramadol at reducing opioid withdrawal symptoms in opioid-dependent individuals
This 6-week inpatient study will enroll opioid-dependent individuals Participants will be required to reside at the research clinic for the entire study All participants will receive morphine maintenance treatment on a daily basis Twice a week participants will take part in experimental challenge sessions in which they will be randomly assigned to receive varying doses of tramadol naloxone morphine or placebo These sessions will assess the ability of tramadol to suppress opioid withdrawal symptoms Participants will complete performance tasks to measure psychomotor and cognitive functioning Heart rate and blood pressure will be monitored throughout the experimental sessions A specialized camera will also be used to assess pupillary response of the eyes Questionnaires and self-reports will be completed to assess medication effects and withdrawal symptoms Following the end of the study all participants will be offered outpatient drug abuse treatment
This 6-week inpatient study will enroll opioid-dependent individuals Participants will be required to reside at the research clinic for the entire study All participants will receive morphine maintenance treatment on a daily basis Twice a week participants will take part in experimental challenge sessions in which they will be randomly assigned to receive varying doses of tramadol naloxone morphine or placebo These sessions will assess the ability of tramadol to suppress opioid withdrawal symptoms Participants will complete performance tasks to measure psychomotor and cognitive functioning Heart rate and blood pressure will be monitored throughout the experimental sessions A specialized camera will also be used to assess pupillary response of the eyes Questionnaires and self-reports will be completed to assess medication effects and withdrawal symptoms Following the end of the study all participants will be offered outpatient drug abuse treatment
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 |
| R01-18125-1 | None | None | None |