QTc and Perceived Sleep Follow up Among Chronic Pain Patients With Opiate Medication
Primary Purpose
Chronic Pain
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Methadone
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Pain focused on measuring Chronic Pain, Methadone, Perceived Sleep, QTc
Eligibility 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
Sites / Locations
- Tel Aviv Sourasky Medical Center, Pain Medicine Unit
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Methadone
Arm Description
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
Outcomes
Primary Outcome Measures
To evaluate the influence of opioid drugs on QTc interval before and during Opioid treatment among patients suffering from chronic pain.
Secondary Outcome Measures
To evaluate the perceived sleep in the chronic pain patients
Full Information
NCT ID
NCT00999440
First Posted
October 20, 2009
Last Updated
January 20, 2010
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00999440
Brief Title
QTc and Perceived Sleep Follow up Among Chronic Pain Patients With Opiate Medication
Official Title
QTc and Perceived Sleep Follow up Among Chronic Pain Patients With Opiate Medication
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic Pain, Methadone, Perceived Sleep, QTc
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Methadone
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To evaluate the perceived sleep in the chronic pain patients
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center, Pain Medicine Unit
City
Tel Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silviu Brill, M.D
12. IPD Sharing Statement
Learn more about this trial
QTc and Perceived Sleep Follow up Among Chronic Pain Patients With Opiate Medication
We'll reach out to this number within 24 hrs