methadone has been researched along with Polyneuropathies in 1 studies
Methadone: A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)
methadone : A racemate comprising equimolar amounts of dextromethadone and levomethadone. It is a opioid analgesic which is used as a painkiller and as a substitute for heroin in the treatment of heroin addiction.
6-(dimethylamino)-4,4-diphenylheptan-3-one : A ketone that is heptan-3-one substituted by a dimethylamino group at position 6 and two phenyl groups at position 4.
Polyneuropathies: Diseases of multiple peripheral nerves simultaneously. Polyneuropathies usually are characterized by symmetrical, bilateral distal motor and sensory impairment with a graded increase in severity distally. The pathological processes affecting peripheral nerves include degeneration of the axon, myelin or both. The various forms of polyneuropathy are categorized by the type of nerve affected (e.g., sensory, motor, or autonomic), by the distribution of nerve injury (e.g., distal vs. proximal), by nerve component primarily affected (e.g., demyelinating vs. axonal), by etiology, or by pattern of inheritance.
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 1 (100.00) | 24.3611 |
2020's | 0 (0.00) | 2.80 |
Authors | Studies |
---|---|
Harrison, T | 1 |
Miyahara, S | 1 |
Lee, A | 1 |
Evans, S | 1 |
Bastow, B | 1 |
Simpson, D | 1 |
Gilron, I | 1 |
Dworkin, R | 1 |
Daar, ES | 1 |
Wieclaw, L | 1 |
Clifford, DB | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Duloxetine and Methadone for the Treatment of HIV-Associated Painful Peripheral Neuropathy[NCT00863057] | Phase 2 | 15 participants (Actual) | Interventional | 2009-05-31 | Terminated (stopped due to Due to slow rate of enrollment, which compromised the ability to meet study objectives in a timely manner.) | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
The CES-D is a 20-item self-report rating inventory measuring characteristic attitudes and symptoms of depression. Participants were asked to score each item: (0) Rarely, (1) Occasionally, (2) Sometimes, and (3) Most of time. Some items are multiplied by -1 to change direction. The overall CES-D score is simply the sum of 20 items. The highest possible total CES-D score is 48, and the lowest possible score is -12. The total CES-D score is considered missing if more than 4 items are not answered. (NCT00863057)
Timeframe: At the fourth treatment week of each treatment period
Intervention | Scores on a scale (Mean) |
---|---|
Duloxetine and Methadone | 13.8 |
Duloxetine and Methadone Placebo | 13.8 |
Duloxetine Placebo and Methadone | 13.3 |
Duloxetine Placebo and Methadone Placebo | 13.3 |
(NCT00863057)
Timeframe: During each treatment period
Intervention | mg (Number) |
---|---|
Methadone | 30 |
Duloxetine | 60 |
"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=''No pain to 10=''Pain as bad as you can imagine.~Participants were given pain diaries at weeks 0, 5, 10, and 15. They started the diary 7 days prior to their clinic visits at weeks 0, 4, 9, 14, and 19. During the 7 days, each morning, they recorded their pain level due to neuropathy by circling the number that best described their neuropathy pain on average during the night time." (NCT00863057)
Timeframe: Over the fourth treatment week of each treatment period
Intervention | Scores on a scale (Mean) |
---|---|
Duloxetine and Methadone | 5.20 |
Duloxetine and Methadone Placebo | 5.82 |
Duloxetine Placebo and Methadone | 5.90 |
Duloxetine Placebo and Methadone Placebo | 6.10 |
"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=''No pain to 10=''Pain as bad as you can imagine at baseline and over the fourth treatment week of each treatment period.~The % of improvement was calculated as (x-y)/x,where x was the MPI score at baseline, and y was the MPI score at the end of each treatment stage." (NCT00863057)
Timeframe: At Baseline and over the fourth treatment week of each treatment period
Intervention | participants (Number) |
---|---|
Duloxetine and Methadone | 2 |
Duloxetine and Methadone Placebo | 2 |
Duloxetine Placebo and Methadone | 2 |
Duloxetine Placebo and Methadone Placebo | 2 |
"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=''No pain to 10=''Pain as bad as you can imagine at baseline and over the fourth treatment week of each treatment period.~The % of improvement was calculated as (x-y)/x,where x was the MPI score at baseline, and y was the MPI score at the end of each treatment stage." (NCT00863057)
Timeframe: At Baseline and over the fourth treatment week of each treatment period
Intervention | participants (Number) |
---|---|
Duloxetine and Methadone | 2 |
Duloxetine and Methadone Placebo | 2 |
Duloxetine Placebo and Methadone | 1 |
Duloxetine Placebo and Methadone Placebo | 2 |
The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 was used (see the link to the grading table in Protocol Section) (NCT00863057)
Timeframe: From study entry to end of study at week 20 or premature study discontinuation
Intervention | Participants (Count of Participants) |
---|---|
Duloxetine and Methadone | 5 |
Duloxetine and Methadone Placebo | 4 |
Duloxetine Placebo and Methadone | 6 |
Duloxetine Placebo and Methadone Placebo | 5 |
"The BPI interference scale measured level of interference with the following seven items:~General activity~Mood~Walking ability~Normal work~Relations with other people~Sleep~Enjoyment of life~Interference scales range from 0='Does not interfere' to 10='Completely interferes'. The overall BPI score is the mean of seven item with the minimum and maximal scores of 0 and 70, respectively." (NCT00863057)
Timeframe: At the fourth week of each treatment period
Intervention | Scores on a scale (Median) |
---|---|
Duloxetine and Methadone | 3.14 |
Duloxetine and Methadone Placebo | 4.14 |
Duloxetine Placebo and Methadone | 3.64 |
Duloxetine Placebo and Methadone Placebo | 3.14 |
"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=''No pain to 10=''Pain as bad as you can imagine.~Participants were given pain diaries at weeks 0, 5, 10, and 15. They started the diary 7 days prior to their clinic visits at weeks 0, 4, 9, 14, and 19. During the 7 days, each morning, they recorded their pain level due to neuropathy by circling the number that best described their neuropathy pain on average over the past 24 hours." (NCT00863057)
Timeframe: During the fourth treatment week of each treatment period
Intervention | Scores on a scale (Mean) |
---|---|
Duloxetine and Methadone | 5.20 |
Duloxetine and Methadone Placebo | 5.91 |
Duloxetine Placebo and Methadone | 6.20 |
Duloxetine Placebo and Methadone Placebo | 5.70 |
"The GIC scale is a validated instrument that consists of seven verbal descriptors on a 7-point scale:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse~Participants were carefully instructed to consider the impact of study treatments on their level of neuropathic pain intensity during the baseline phase of the study." (NCT00863057)
Timeframe: At the fourth treatment week of each treatment period
Intervention | participants (Number) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
PGIC - Very much improved | PGIC - Much improved | PGIC - Minimally improved | PGIC - No change | PGIC - Much worse | CGIC - Very much improved | CGIC - Much improved | CGIC - Minimally improved | CGIC - No change | CGIC - Much worse | |
Duloxetine and Methadone | 1 | 4 | 2 | 3 | 0 | 1 | 4 | 1 | 4 | 0 |
Duloxetine and Methadone Placebo | 0 | 1 | 4 | 6 | 0 | 1 | 1 | 1 | 8 | 0 |
Duloxetine Placebo and Methadone | 1 | 2 | 4 | 2 | 1 | 1 | 3 | 3 | 3 | 0 |
Duloxetine Placebo and Methadone Placebo | 1 | 1 | 4 | 4 | 0 | 1 | 1 | 3 | 4 | 1 |
(NCT00863057)
Timeframe: During each treatment period and the subsequent cross-over (or final study week) period
Intervention | participants (Number) | |
---|---|---|
Treatment period (1-4, 6-9, 11-14, 16-19 weeks) | Cross-over period (5, 10, 15, 20 weeks) | |
Duloxetine and Methadone | 0 | 1 |
Duloxetine and Methadone Placebo | 0 | 0 |
Duloxetine Placebo and Methadone | 0 | 1 |
Duloxetine Placebo and Methadone Placebo | 2 | 1 |
1 trial available for methadone and Polyneuropathies
Article | Year |
---|---|
Experience and challenges presented by a multicenter crossover study of combination analgesic therapy for the treatment of painful HIV-associated polyneuropathies.
Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Comorbidity; Cross-Over Studies; Double-Blind Method; D | 2013 |