Clinical trial NCT02335398: Development and Evaluation of a Methadone Protocol for Severe Chronic Pain Management
Official title: Development and Evaluation of a Methadone Protocol for Severe Chronic Pain Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Chronic
Keywords: methadone
chronic pain
noncancer pain
cancer pain
QTc prolongation
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-01-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Methadone is a synthetic mu opioid agonist that has been proved as clinically effective in pain management. However, methadone usage for pain control in Thailand has been limited because physicians are not familiar with its dosing and concern about the risk of drug accumulation and cardiac arrhythmia. Therefore, this prospective study was conducted to evaluate the efficacy and safety of a methadone protocol in Thai patients with severe chronic noncancer and cancer pain.

Detailed description: Chronic pain is defined as pain that persists beyond normal tissue healing time, which is assumed for 3 months by the IASP. The symptoms include either continuous or intermittent pain, that could be caused by tumor or other multiple etiologies. The consequence of uncontrolled chronic pain presents not only physiologic symptoms but also psychiatric disorders leading to severely impact daily living.

In Thailand, the use of methadone for pain management has been limited because physicians are not familiar with its dosing and concern about the risk of drug accumulation and cardiac arrhythmia. Therefore, the aim of this study is to evaluate the efficacy and safety of a protocol of methadone dosing in outpatients with severe chronic pain.

Thirty four chronic pain patients will be included to initiate methadone use following the protocol. Pain scores, pain interferences scores, neuropathic pain score, severity of adverse effects, and QTc intervals will be assessed at baseline, and two, four, eight, and twelve weeks after starting methadone.

The approved protocol of methadone therapy obtained from this study could be clinically utilized by physicians for severe chronic pain management.

Eligibility criteria: Inclusion Criteria:

* Outpatients aged 18 or over who suffered from severe chronic cancer or noncancer pain to be firstly treated with methadone as analgesics

Exclusion Criteria:

* QTc interval that was more than 500 msec
* History of opioid addiction
* Having structural heart diseases
* During pregnancy or lactation period
* Patients who have hypersensitivity to methadone

Primary outcomes:
measure: Pain score
timeFrame: 3 months
Secondary outcomes:
measure: pain interferences scores
timeFrame: 3 months
measure: severity of adverse effects
timeFrame: 3 months
measure: QTc intervals
timeFrame: 3 months
measure: Neuropathic pain score
timeFrame: 3 months
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Thailand: Faculty of Pharmacy, Mahidol University
name: Chuthamanee Suthisisang, Ph.D.
role: STUDY_CHAIR
affiliation: Thailand: Faculty of Pharmacy, Mahidol University
name: Phutsadee Pudchakan, Bsc.Pharm
role: PRINCIPAL_INVESTIGATOR
affiliation: Thailand: Faculty of Pharmacy, Mahidol University
name: Krittika Tanyasaensook, Ph.D.
role: STUDY_DIRECTOR
affiliation: Thailand: Faculty of Medicine Siriraj Hospital
name: Pongparadee Chaudakshetrin, M.D.
role: STUDY_DIRECTOR
References:
citation: Mercadante S, Casuccio A, Calderone L. Rapid switching from morphine to methadone in cancer patients with poor response to morphine. J Clin Oncol. 1999 Oct;17(10):3307-12. doi: 10.1200/JCO.1999.17.10.3307.
citation: Mercadante S, Casuccio A, Fulfaro F, Groff L, Boffi R, Villari P, Gebbia V, Ripamonti C. Switching from morphine to methadone to improve analgesia and tolerability in cancer patients: a prospective study. J Clin Oncol. 2001 Jun 1;19(11):2898-904. doi: 10.1200/JCO.2001.19.11.2898.
citation: Ripamonti C, Groff L, Brunelli C, Polastri D, Stavrakis A, De Conno F. Switching from morphine to oral methadone in treating cancer pain: what is the equianalgesic dose ratio? J Clin Oncol. 1998 Oct;16(10):3216-21. doi: 10.1200/JCO.1998.16.10.3216.
citation: Bruera E, Sweeney C. Methadone use in cancer patients with pain: a review. J Palliat Med. 2002 Feb;5(1):127-38. doi: 10.1089/10966210252785097.
citation: Pearson EC, Woosley RL. QT prolongation and torsades de pointes among methadone users: reports to the FDA spontaneous reporting system. Pharmacoepidemiol Drug Saf. 2005 Nov;14(11):747-53. doi: 10.1002/pds.1112.