QTc and Perceived Sleep Follow up Among Chronic Pain Patients With Opiate Medication

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00999440

Enrollment

100

Registered

2009-10-21

Start date

2010-01-31

Completion date

2011-12-31

Last updated

2010-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Chronic Pain, Methadone, Perceived Sleep, QTc

Brief summary

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

Interventions

DRUGMethadone

ECG (QT, QTc, Heart rate), Urine sample (opiates, benzodiazepines, THC, cocaine, amphetamines, methadone-metabolite), Questionnaire PSQI - perceived sleep - self report , Pain indices (severity, duration, cause, etc.) , usage of other medication for pain and other significant disease/disorders, history of drug abuse, age, sex, place of birth and ethnic origin, comorbidity. Follow up after 4weeks, 6months and 1 year will be done. Patients who start with any opiate and then switch to methadone, move to methadone follow up

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To evaluate the influence of opioid drugs on QTc interval before and during Opioid treatment among patients suffering from chronic pain.	1 year

Secondary

Measure	Time frame
To evaluate the perceived sleep in the chronic pain patients	1 year

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026