Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01189097
Other study ID # HR-95-139
Secondary ID
Status Recruiting
Phase Phase 3
First received August 23, 2010
Last updated August 25, 2010
Start date April 2008
Est. completion date September 2011

Study information

Verified date August 2010
Source National Cheng-Kung University Hospital
Contact Ru-Band Lu, MD
Phone +886-6-2353535
Email rblu@mail.ncku.edu.tw
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Description:

Opioid dependence is a severe public health problem. Current efforts to taper individuals off opioid medications are limited due to a high relapse rate and lack of efficacy in relieving subjective symptoms. Methadone substitution therapies might decrease the criminal rate and increase the quality of life for individuals with opioid dependence, but the high drop-out rate and continuing use of methadone are major problems in the maintenance of therapy for opioid dependence. Studies in the pathogenesis of opioid dependence and additional behaviors need more focused attention.

Dextromethorphan (DM) is a noncompetitive N-methyl-D-aspartate receptor antagonist that has proven safety record for anti-tussive purpose. Previous studies demonstrated that DM may be useful in decreasing craving in animals (Huang, et al., 2003; Lue et al., 2007) and withdrawal tendencies in human with opioid dependence. In recent studies, DM has been reported to afford neuroprotection against endotoxin-induced dopaminergic neurotoxicity (Li et al. 2005; Liu et al. 2003; Zhang et al. 2004, 2005) which might be related to treatment for additictive behaviors. The purposes of this study are to examine whether DM is able to 1) reduce opioid tolerance and decrease methadone use; 2) reduce withdrawal symptoms; 3) decrease the relapse rate of opioid use, and 4) be an effective treatment for opioid dependence (and addictive behaviors).

This is a double-blinded, placebo-controlled, randomized, and parallel groups clinical research trial study. Subjects with opioid dependence are recruited from two different sources. One group will come from the list of current opioid users and will be required to stay on methadone treatment (opioid using group), and the second group will come from subjects who are forced to discontinue opioid use for more than one week (opioid free group).

In the opioid using group, add-on of DM or placebo treatment will proceed in a double-blind fashion for 12 weeks after completed structured diagnostic interview and adjusted methadone dose. In the opioid free group, subjects will take one-week placebo for the wash-out period first and then will be admitted into a double-blind DM/placebo only for 12 weeks. Both opioid using and opioid free groups will be examined weekly through urine tests for opioid use and will be assessed on a craving scale after the completion of the structured diagnostic interviews. We will measure the treatment response and side effects to clarify the curative effects of DM with the use of the double-blinded DM/placebo therapy design in both the opioid using and opioid free groups. Several psychological examinations, psychosocial questionnaires, tests for immune parameters, electrophysiological studies and genetic markers will be performed in this study. The interim analysis and decording of partial subjects who completed DM/placebo add-on treatment for three months will be performed in the end of first year.


Recruitment information / eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dextromethorphan
Subjects who have not used opioid for at least one week before baseline evaluation will take one-week placebo for the wash-out period first and then will be categorized into the opioid free group. The subjects of the opioid using group will be assigned randomly into the following six groups: 1) Methadone + DM 60mg; 2) Methadone + DM 120mg; 3) Methadone + Placebo; 4) Methadone + DM 60mg + motivation and cognitive behavior therapy; 5) Methadone + DM 120mg + motivation and cognitive behavior therapy; 6) Methadone + Placebo + motivation and cognitive behavior therapy. The opioid free group will be 1) DM 30mg; 2) DM 60 mg; 3) Placebo.
Dextromethorphan
Subjects who have not used opioid for at least one week before baseline evaluation will take one-week placebo for the wash-out period and then randomly assigned into six groups: 1) Methadone + DM 60mg; 2) Methadone + DM 120mg; 3) Methadone + Placebo; 4) Methadone + DM 60mg + motivation and cognitive behavior therapy; 5) Methadone + DM 120mg + motivation and cognitive behavior therapy; 6) Methadone + Placebo + motivation and cognitive behavior therapy. The opioid free group will be 1) DM 30mg; 2) DM 60 mg; 3) Placebo. If the subjects of the opioid free group suffer from relapses and begin to use heroin, they will receive methadone treatment. The dosage of methadone will be increased or decreased maximal 5 mg each time as necessary.

Locations

Country Name City State
Taiwan Ru-Band Lu Tainan

Sponsors (1)

Lead Sponsor Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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
See also
  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