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Study of D-Methadone in Patients With Chronic Pain

Primary Purpose

Pain, Bladder Cancer, Breast Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

d-Methadone

D-methadone

placebo

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain, HEENT cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

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.

Exclusion Criteria:

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,
- 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.

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Phase I, Group

Phase II, Group I

Phase II, Group II

Arm Description

This is an open label dose-ranging trial. The first cohort of 8 patients will receive 40mg of d-methadone every 12 hours.

patients receiving around the clock opioid therapy-No patients were accrued to this group

patients not receiving around the clock opioid therapy.No patients were accrued to this group

Outcomes

Primary Outcome Measures

Number Who Reached a Safe Dose

The number of patients who reached a safe and well tolerated dose of d-methadone

Secondary Outcome Measures

Full Information

NCT ID

NCT00588640

First Posted

December 22, 2007

Last Updated

June 29, 2016

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00588640

Brief Title

Study of D-Methadone in Patients With Chronic Pain

Official Title

A Phase I/II Study of D-Methadone in Patients With Chronic Pain

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Bladder Cancer, Breast Cancer, CNS Cancer, Colon Cancer, Esophageal Cancer, Pancreatic Cancer, Prostate Cancer, Uterine Cancer, Head and Neck Cancer, Eye Cancer, Otorhinolaryngologic Neoplasms

Keywords

Pain, HEENT cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase I, Group

Arm Type

Experimental

Arm Description

This is an open label dose-ranging trial. The first cohort of 8 patients will receive 40mg of d-methadone every 12 hours.

Arm Title

Phase II, Group I

Arm Type

Experimental

Arm Description

patients receiving around the clock opioid therapy-No patients were accrued to this group

Arm Title

Phase II, Group II

Arm Type

Experimental

Arm Description

patients not receiving around the clock opioid therapy.No patients were accrued to this group

Intervention Type

Drug

Intervention Name(s)

d-Methadone

Intervention Description

8 subjects to receive 40 mg d-Methadone twice a day

Intervention Type

Drug

Intervention Name(s)

D-methadone

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number Who Reached a Safe Dose

Description

The number of patients who reached a safe and well tolerated dose of d-methadone

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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. Exclusion Criteria: 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, 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Natalie Moryl, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org

Description

Memorial Sloan Kettering Cancer Center

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Study of D-Methadone in Patients With Chronic Pain

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