Opioid AbusePhase 3DMNCT01189097
Combined Therapy of Methadone and Dextromethrophan
A Phase 3 study testing Dextromethorphan in people with Opioid Abuse, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Abuse
- What is being tested?
- Dextromethorphan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2008to Sep 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Ru-Band Lu
Tainan, 704
Ru-Band Lu, MD, +886-6-2353535 ext. 5108, rblu@mail.ncku.edu.tw
Ru-Band Lu, MD
About this study
Official 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.
Read the detailed 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.
- Conditions
- Opioid Abuse
- Being tested
- Dextromethorphan
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextromethorphanDrug
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.
DextromethorphanDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| dextromethorphan | Experimental | Not described Receives: Drug: Dextromethorphan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary examination
Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.
Measured: baseline
Urinary examination
Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.
Measured: week 1
Urinary examination
Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.
Measured: week2
Urinary examination
Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.
Measured: week4
Urinary examination
Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.
Measured: week8
Urinary examination
Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.
Measured: week12
Secondary outcomes (6)
cytokines
Measured: baseline
cytokines
Measured: week1
cytokines
Measured: week2
cytokines
Measured: week4
cytokines
Measured: week8
cytokines
Measured: week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startApr 2008
- Primary completionMar 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid AbuseStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ru-Band Lu, MD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189097
- Sponsor's protocol ID
- HR-95-139
- Acronym
- DM
- Status last verified
- Aug 2010
- First submitted
- 23 Aug 2010
- Last updated
- 26 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Therapy of Methadone and Dextromethrophan: A Novel Strategy for the Treatment of Opioid Dependence
- ClinicalTrials.gov ID
- NCT01189097
- Acronym / sponsor ID
- DM / HR-95-139
- Conditions
- Opioid Abuse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 26 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dextromethorphan | Experimental | Drug: Dextromethorphan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DextromethorphanSubjects 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. | Drug | dextromethorphan |
| DextromethorphanSubjects 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. | Drug | dextromethorphan |
Primary outcome
Urinary examination
Time frame: baseline
Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.
Urinary examination
Time frame: week 1
Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.
Urinary examination
Time frame: week2
Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.
Urinary examination
Time frame: week4
Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.
Urinary examination
Time frame: week8
Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.
Urinary examination
Time frame: week12
Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.
6 secondary outcomes
cytokines
Time frame: baseline
cytokines
Time frame: week1
cytokines
Time frame: week2
cytokines
Time frame: week4
cytokines
Time frame: week8
cytokines
Time frame: week12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2010.
Related trials for Opioid Abuse
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Active, not recruitingObservational study
Cannabis Use and Outcomes in Black and White Patients With Cancer
Cancer
Active, not recruiting
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Opioid Dependence, Substance Abuse Disorders
Recruiting
Improving Jail Response to the Overdose Crisis: A Hybrid Trial of Jail ECHO to Improve MOUD Implementation and Public Health Outcomes
Opioid Abuse (Disorder)
RecruitingPhase 4
Abuse Potential of Gabapentin Taken Orally Concomitantly With Oxycodone Hydrochloride in Healthy, Non-Drug-Dependent, Recreational Opioid Users
Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ru-Band Lu, MD principal investigator
National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dextromethorphan in people with Opioid Abuse, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ru-Band Lu, MD (+886-6-2353535 ext. 5108, rblu@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary examination (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2010.