Combined Therapy of Methadone and Dextromethrophan

NCT01189097 | Unknown Phase 3 DMC

• 1 other identifier: HR-95-139
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Abuse

Outcome Measures

Primary Outcomes (6)

• Urinary examination

  Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.

  baseline

• Urinary examination

  Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.

  week 1

• Urinary examination

  Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.

  week2

• Urinary examination

  Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.

  week4

• Urinary examination

  Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.

  week8

• Urinary examination

  Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.

  week12

Secondary Outcomes (6)

• cytokines

  baseline

• cytokines

  week1

• cytokines

  week2

• cytokines

  week4

• cytokines

  week8

Study Arms (1)

dextromethorphan

EXPERIMENTAL

Drug: Dextromethorphan

Interventions

Dextromethorphan DRUG

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent by patient or legal representative.
• Male or female patient aged ≧18 and ≦65 years.
• A diagnosis of opioid dependence according to DSM-IV criteria made by a specialist in psychiatry.
• Patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.

You may not qualify if:

• 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.
• Females who are pregnant or nursing.
• Patient has received DM or other anti-inflammatory medications within 1 week prior to the first dose of the double-blinded medication.
• 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.
• 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.
• History of intolerance to methadone or DM.
• History of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) to DM.
• Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to the first dose of the double-blinded medication.
• Increase in total SGOT, SGPT, gamma-GT, BUN and creatinine by more than 3X ULN (upper limit of normal).

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

Ru-Band Lu

Tainan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Dextromethorphan

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Ru-Band Lu, MD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru-Band Lu, MD

CONTACT

+886-6-2353535; rblu@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 23, 2010
• First Posted: August 26, 2010
• Study Start: April 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: September 1, 2011
• Last Updated: August 26, 2010

Record last verified: 2010-08

Locations

TW (1)