QTc and Perceived Sleep Follow up Among Chronic Pain Patients With Opiate Medication
Unknown statusNot applicableNCT00999440
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
QTc: Since the reports of three deaths attributed to Torsade de Point (TdP) related to treatment with the long-acting methadone derivative levomethadyl acetate HCl (LAAM), methadone has been scrutinized for any possible association with TdP. Since then, several studies among Methadone Maintenance Treatment (MMT) patients and chronic pain patients were done, reporting diverse results about possible association between methadone dose and QTc prolongation. Most studies however were cross-sectional and generally found insignificant clinical prolongation of QTc. A follow up studies are of importance, and although few studies have started evaluating QTc among MMT patients, none was done among chronic pain patients with no history of drug usage. One study of 8 chronic pain patients experiencing insufficient pain control or intolerable side effects during treatment with oral morphine switched to oral methadone showed insignificant modest increase QTc following 9 month. Perceived Sleep: Chronic pain patients as well as drug addicts are known to suffer from poor sleep. Some studies found possible relation to methadone dose, however, no causal association was found and importantly some also found association with duration of opiate usage before starting methadone when entry to MMT clinic. Thus, patients with no history of opiate addiction are an important interesting group that may help understand relation between methadone usage and sleep quality. However, sleep must be evaluate before opiate administration and a follow up study is needed
Study details
- Official title
- QTc and Perceived Sleep Follow up Among Chronic Pain Patients With Opiate Medication
- Conditions
- Interventions
- Sponsor
- Tel-Aviv Sourasky Medical Center
- Start date
- 2010-01
- Primary completion
- 2010-12
- Sex
- All
- Age range
- from 18 Years to 90 Years
- Results posted
- No results posted in this snapshot
- Countries
- Israel
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * adults (18+ years) patients with chronic pain, who intend to be medicated with any opiates Exclusion Criteria: * patient with no opiate usage through last year
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00999440