Page last updated: 2024-10-30

methadone and Polyneuropathies

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.

Research

Studies (1)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's1 (100.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Harrison, T1
Miyahara, S1
Lee, A1
Evans, S1
Bastow, B1
Simpson, D1
Gilron, I1
Dworkin, R1
Daar, ES1
Wieclaw, L1
Clifford, DB1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Duloxetine and Methadone for the Treatment of HIV-Associated Painful Peripheral Neuropathy[NCT00863057]Phase 215 participants (Actual)Interventional2009-05-31Terminated (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]

Trial Outcomes

Emotional Functioning as Measured by the Center for Epidemiologic Studies Depression Scale (CES-D)

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

InterventionScores on a scale (Mean)
Duloxetine and Methadone13.8
Duloxetine and Methadone Placebo13.8
Duloxetine Placebo and Methadone13.3
Duloxetine Placebo and Methadone Placebo13.3

Maximum Tolerated Dose of Duloxetine and Methadone

(NCT00863057)
Timeframe: During each treatment period

Interventionmg (Number)
Methadone30
Duloxetine60

Mean Nighttime Pain Measure on an 11-point Likert Scale

"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

InterventionScores on a scale (Mean)
Duloxetine and Methadone5.20
Duloxetine and Methadone Placebo5.82
Duloxetine Placebo and Methadone5.90
Duloxetine Placebo and Methadone Placebo6.10

Number of Participants With 30% or More Improvement in Mean Pain Score on an 11-point Likert Scale

"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

Interventionparticipants (Number)
Duloxetine and Methadone2
Duloxetine and Methadone Placebo2
Duloxetine Placebo and Methadone2
Duloxetine Placebo and Methadone Placebo2

Number of Participants With 50% or More Improvement in Mean Pain Score on an 11-point Likert Scale

"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

Interventionparticipants (Number)
Duloxetine and Methadone2
Duloxetine and Methadone Placebo2
Duloxetine Placebo and Methadone1
Duloxetine Placebo and Methadone Placebo2

Number of Participants With Treatment-emergent Grade 2 to 4 Adverse Events

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

InterventionParticipants (Count of Participants)
Duloxetine and Methadone5
Duloxetine and Methadone Placebo4
Duloxetine Placebo and Methadone6
Duloxetine Placebo and Methadone Placebo5

Pain-related Interference Measured by the Brief Pain Inventory (BPI) Interference Items

"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

InterventionScores on a scale (Median)
Duloxetine and Methadone3.14
Duloxetine and Methadone Placebo4.14
Duloxetine Placebo and Methadone3.64
Duloxetine Placebo and Methadone Placebo3.14

Weekly Mean Pain Score Derived From Self-reported Average Daily Pain Intensity on an 11-point Likert Scale

"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

InterventionScores on a scale (Mean)
Duloxetine and Methadone5.20
Duloxetine and Methadone Placebo5.91
Duloxetine Placebo and Methadone6.20
Duloxetine Placebo and Methadone Placebo5.70

Patient and Clinician Global Impression of Change (PGIC and CGIC) on a 7-point Likert Scale

"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

,,,
Interventionparticipants (Number)
PGIC - Very much improvedPGIC - Much improvedPGIC - Minimally improvedPGIC - No changePGIC - Much worseCGIC - Very much improvedCGIC - Much improvedCGIC - Minimally improvedCGIC - No changeCGIC - Much worse
Duloxetine and Methadone1423014140
Duloxetine and Methadone Placebo0146011180
Duloxetine Placebo and Methadone1242113330
Duloxetine Placebo and Methadone Placebo1144011341

Use of Rescue Medication (Acetaminophen)

(NCT00863057)
Timeframe: During each treatment period and the subsequent cross-over (or final study week) period

,,,
Interventionparticipants (Number)
Treatment period (1-4, 6-9, 11-14, 16-19 weeks)Cross-over period (5, 10, 15, 20 weeks)
Duloxetine and Methadone01
Duloxetine and Methadone Placebo00
Duloxetine Placebo and Methadone01
Duloxetine Placebo and Methadone Placebo21

Trials

1 trial available for methadone and Polyneuropathies

ArticleYear
Experience and challenges presented by a multicenter crossover study of combination analgesic therapy for the treatment of painful HIV-associated polyneuropathies.
    Pain medicine (Malden, Mass.), 2013, Volume: 14, Issue:7

    Topics: Adult; Aged; Analgesics; Analgesics, Opioid; Comorbidity; Cross-Over Studies; Double-Blind Method; D

2013