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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00999440
First received: October 20, 2009
Last updated: January 20, 2010
Last verified: December 2009
  Purpose

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


Condition Intervention
Chronic Pain
Drug: Methadone

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: QTc and Perceived Sleep Follow up Among Chronic Pain Patients With Opiate Medication

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • To evaluate the influence of opioid drugs on QTc interval before and during Opioid treatment among patients suffering from chronic pain. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the perceived sleep in the chronic pain patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methadone
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
Drug: Methadone
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999440

Locations
Israel
Tel Aviv Sourasky Medical Center, Pain Medicine Unit Not yet recruiting
Tel Aviv, Israel
Principal Investigator: Silviu Brill, M.D         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center, Pain Medicine Unit
ClinicalTrials.gov Identifier: NCT00999440     History of Changes
Other Study ID Numbers: TASMC-09-SB-0104-09-CTIL
Study First Received: October 20, 2009
Last Updated: January 20, 2010
Health Authority: Israel: Ethics Commission

Keywords provided by Tel-Aviv Sourasky Medical Center:
Chronic Pain
Methadone
Perceived Sleep
QTc

Additional relevant MeSH terms:
Methadone
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 30, 2014