Opioid Abuse Clinical Trial
— DMOfficial title:
Combined Therapy of Methadone and Dextromethrophan: A Novel Strategy for the Treatment of Opioid Dependence
The purpose of this study is to determine the pharmacological effects and outcomes of DM
therapy with this add-on study.
And to determine the immunological changes between the baseline and the end point of the
study.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | September 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Signed informed consent by patient or legal representative. 2. Male or female patient aged ?18 and ?65 years. 3. A diagnosis of opioid dependence according to DSM-IV criteria made by a specialist in psychiatry. 4. Patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study. Exclusion Criteria: 1. Women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study. 2. Females who are pregnant or nursing. 3. Patient has received DM or other anti-inflammatory medications within 1 week prior to the first dose of the double-blinded medication. 4. Other major Axis-I DSM-IV diagnosis other than opioid dependence such as multiple substance dependence within 1 year prior to the fist dose of the double-blinded medication. 5. Current evidence of an uncontrolled and/or clinically significant medical condition, e.g., cardiac, hepatic and renal failure that would compromise patient safety or preclude study participation. 6. History of intolerance to methadone or DM. 7. History of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) to DM. 8. Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to the first dose of the double-blinded medication. 9. Increase in total SGOT, SGPT, gamma-GT, BUN and creatinine by more than 3X ULN (upper limit of normal). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Ru-Band Lu | Tainan |
Lead Sponsor | Collaborator |
---|---|
National Cheng-Kung University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urinary examination | Using urinary examination is aimed to test whether the drug dependence is still using morphine or not. | baseline | No |
Primary | Urinary examination | Using urinary examination is aimed to test whether the drug dependence is still using morphine or not. | week 1 | No |
Primary | Urinary examination | Using urinary examination is aimed to test whether the drug dependence is still using morphine or not. | week2 | No |
Primary | Urinary examination | Using urinary examination is aimed to test whether the drug dependence is still using morphine or not. | week4 | No |
Primary | Urinary examination | Using urinary examination is aimed to test whether the drug dependence is still using morphine or not. | week8 | No |
Primary | Urinary examination | Using urinary examination is aimed to test whether the drug dependence is still using morphine or not. | week12 | No |
Secondary | cytokines | baseline | No | |
Secondary | cytokines | week1 | No | |
Secondary | cytokines | week2 | No | |
Secondary | cytokines | week4 | No | |
Secondary | cytokines | week8 | No | |
Secondary | cytokines | week12 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT04839978 -
Community Trial in the Cherokee Nation
|
N/A | |
Completed |
NCT05593341 -
Opioid Education in Total Knee Arthroplasty
|
N/A | |
Terminated |
NCT04495374 -
Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy
|
Phase 4 | |
Terminated |
NCT03822962 -
Pain Management Following Sinus Surgery
|
Early Phase 1 | |
Completed |
NCT03936985 -
Validation of a Community Pharmacy-Based Prescription Drug Monitoring Program Risk Screening Tool
|
||
Active, not recruiting |
NCT01740414 -
Effects of Ibudilast on Oxycodone Self-administration in Opioid Abusers
|
Phase 2 | |
Completed |
NCT00499746 -
The Discriminative Effects of Tramadol in Humans
|
Phase 1/Phase 2 | |
Completed |
NCT03684681 -
The Navigator Trial
|
N/A | |
Completed |
NCT04340622 -
Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders
|
N/A | |
Completed |
NCT04018664 -
Oral Abuse Potential Study of Nalbuphine
|
Phase 1 | |
Completed |
NCT00699010 -
Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse
|
Phase 2 | |
Recruiting |
NCT05006079 -
Opioid/Benzodiazepine Polydrug Abuse: Aim 3
|
Phase 2 | |
Completed |
NCT04710069 -
Postoperative Opt-In Narcotic Treatment Study
|
N/A | |
Terminated |
NCT03992079 -
A Multimodal Enhanced Recovery Program in Anorectal Surgery
|
N/A | |
Active, not recruiting |
NCT03570099 -
Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications
|
||
Completed |
NCT02804152 -
Program for Pain & Prescription Opioid Use in Pregnancy
|
N/A | |
Active, not recruiting |
NCT01632982 -
Mobile Psychosocial Interventions for MMT Clients
|
N/A | |
Active, not recruiting |
NCT01136356 -
A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05706311 -
Community Pharmacy-Based Prescription Drug Monitoring Program Opioid Risk Assessment Tool
|
N/A | |
Completed |
NCT03743493 -
PCORnet Opioid Surveillance Study
|