PainPhase 1/2NCT00588640
Study of D-Methadone in Patients With Chronic Pain
A Phase 1/2 study testing d-Methadone in people with Pain and Bladder Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the safest dose of d-methadone that can be given, without causing severe side effects in most patients with chronic pain. Patients are being asked to participate in the Phase I portion of this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Bladder Cancer, Breast Cancer
- What is being tested?
- d-Methadone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Jul 2008
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase I and Phase II portions of the study:
- 18 years of age or older
- Chronic pain with average 24 hour intensity rated at least 3 on a verbal numerical scale from 0-10 during the 24 hours prior to study entry.
- Give informed consent to participate in this study.
- Karnofsky Performance Score (KPS) >= to 80
- Negative urine pregnancy test, verified by the study nurse, at study entry (for women of child-bearing potential). Patients must also use a medically approved contraceptive method during the study period.
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- Phase I only:
- Responsible companion living with patient during study.
- Phase II only:
- Group 1 -- Patients must be taking chronic opioid therapy (long acting morphine, long acting oxycodone, transdermal fentanyl) at a stable dose for a minimum of four days. The dose of as needed short acting opioid does not need to be stable.
- Group 2 -- Patients must not be receiving opioids and must have cancer related neuropathic pain secondary to post-chemotherapy peripheral neuropathy, post-radiation and/or post surgical plexopathy, radiculopathy or neuropathy, or post- herpetic neuralgia.
Who cannot join
- Phase I and Phase II:
- Known hypersensitivity to methadone
- Patient taking methadone or with a history of methadone treatment within one month of study enrollment.
- Patient that requires changes in the dose of one of the following medications within 2 weeks of study enrollment:
- Abacavir,
- Benzodiazepines,
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- Carbamazepine,
- Efavirenz,
- Fluconazole,
- Fluvoxamine,
- FOS amprenavir,
- Fosphenytoin,
- Naltrexone,
- Nelfinavir,
- Nevirapine,
- Phenytoin,
- Rifampin,
- Rifapentine,
- Risperidone,
- Ritonavir,
- St. John's Wort,
- Zidovudine
- Hepatic function tests (SGOT, alkaline phosphatase, bilirubin) greater than 2 times the upper limit of normal or creatinine greater than 1.4 within 30 days of study entry.
- Neurologic or psychiatric disease sufficient, in the investigator's opinion, to compromise data collection.
- Women who are pregnant or nursing.
- Women of childbearing potential who do not agree to use a medically recognized method of contraception during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase I/II Study of D-Methadone in Patients With Chronic Pain
The purpose of this study is to determine the safest dose of d-methadone that can be given, without causing severe side effects in most patients with chronic pain. Patients are being asked to participate in the Phase I portion of this study.
- Conditions
- Pain, Bladder Cancer, Breast Cancer, CNS Cancer, Colon Cancer, Esophageal Cancer
- Being tested
- d-Methadone, placebo
- Keywords
- Pain, HEENT cancer
- Medical subject headings
- Pain, Urinary Bladder Neoplasms, Breast Neoplasms, Central Nervous System Neoplasms, Colonic Neoplasms, Esophageal Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
d-MethadoneDrug
8 subjects to receive 40 mg d-Methadone twice a day
D-methadoneDrug
After randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24.
placeboDrug
After randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24.
| Study group | Role | What they receive |
|---|---|---|
| Phase I, Group | Experimental | This is an open label dose-ranging trial. The first cohort of 8 patients will receive 40mg of d-methadone every 12 hours. Receives: Drug: d-Methadone |
| Phase II, Group I | Experimental | patients receiving around the clock opioid therapy-No patients were accrued to this group Receives: Drug: D-methadone |
| Phase II, Group II | Experimental | patients not receiving around the clock opioid therapy.No patients were accrued to this group Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Who Reached a Safe Dose
The number of patients who reached a safe and well tolerated dose of d-methadone
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startOct 2004
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalie Moryl, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588640
- Sponsor's protocol ID
- 01-017
- Status last verified
- Jun 2016
- First submitted
- 22 Dec 2007
- Last updated
- 10 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of D-Methadone in Patients With Chronic Pain
- ClinicalTrials.gov ID
- NCT00588640
- Acronym / sponsor ID
- 01-017
- Conditions
- Pain, Bladder Cancer, Breast Cancer, CNS Cancer, Colon Cancer, Esophageal Cancer
- Keywords
- Pain, HEENT cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 8 Jan 2008 (estimated)
- Results
- Posted 10 Aug 2016
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 safest dose of d-methadone that can be given, without causing severe side effects in most patients with chronic pain. Patients are being asked to participate in the Phase I portion of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I, Group | Experimental | Drug: d-MethadoneThis is an open label dose-ranging trial. The first cohort of 8 patients will receive 40mg of d-methadone every 12 hours. |
| Phase II, Group I | Experimental | Drug: D-methadonepatients receiving around the clock opioid therapy-No patients were accrued to this group |
| Phase II, Group II | Experimental | Drug: placebopatients not receiving around the clock opioid therapy.No patients were accrued to this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years of age or older
- Chronic pain with average 24 hour intensity rated at least 3 on a verbal numerical scale from 0-10 during the 24 hours prior to study entry.
- Give informed consent to participate in this study.
- Karnofsky Performance Score (KPS) >= to 80
- Negative urine pregnancy test, verified by the study nurse, at study entry (for women of child-bearing potential). Patients must also use a medically approved contraceptive method during the study period.
Key exclusion criteria (26 listed)
- Known hypersensitivity to methadone
- Patient taking methadone or with a history of methadone treatment within one month of study enrollment.
- Patient that requires changes in the dose of one of the following medications within 2 weeks of study enrollment:
- Hepatic function tests (SGOT, alkaline phosphatase, bilirubin) greater than 2 times the upper limit of normal or creatinine greater than 1.4 within 30 days of study entry.
- Neurologic or psychiatric disease sufficient, in the investigator's opinion, to compromise data collection.
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 |
|---|---|---|
| d-Methadone8 subjects to receive 40 mg d-Methadone twice a day | Drug | Phase I, Group |
| D-methadoneAfter randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24. | Drug | Phase II, Group I |
| placeboAfter randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24. | Drug | Phase II, Group II |
Primary outcome
Number Who Reached a Safe Dose
Time frame: 2 years
The number of patients who reached a safe and well tolerated dose of d-methadone
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Natalie Moryl, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing d-Methadone in people with Pain and Bladder Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 11 inclusion and 26 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: finished, as of the sponsor's last update on 10 Aug 2016. 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number Who Reached a Safe Dose (time frame: 2 years). 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 10 Aug 2016; AzTrials last refreshed its copy on 7 Nov 2026.