A Multi-centre Survey on Tramadol Abuse in Singapore

March 21, 2021 updated by: Singapore General Hospital

The rampant prescription of opioid has in part contributed to the ongoing worldwide opioid crisis. In the United States of America, it is estimated that death from the use of opioids outnumber death from motor vehicle accident deaths by more than 40%. Consequently, many countries such as America and Canada have drawn up guidelines pertaining to safe opioid prescribing.

Tramadol is often used by pain physicians to treat chronic pain. As it is a weak opioid and unscheduled in many countries, it is often considered to have a lower addiction potential compared to strong opioids. Despite this, the literature does reveal evidence of abuse, addiction and withdrawal - although the incidence of this is unclear.

In this study, the investigators aim to determine the prevalence of tramadol misuse in a pain clinic population. The investigators also aim to determine the real-life compliance of physicians to guidelines provided by International regulatory bodies (CDC) and the modifiable risk factors associated with tramadol misuse.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who attends pain clinic in SGH, SKGH and CGH.

Description

Inclusion Criteria:

  • All patients attending pain clinic in Singapore General Hospital, Seng Kang General Hospital and Changi General Hospital

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Current Opioid Misuse Measure (COMM)
Time Frame: Baseline
The primary outcome is the prevalence of Current Opioid Misuse (defined as a COMM score of 9 or greater) in the patients included in the cross-sectional study (ie patients who are on tramadol)
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline
PHQ-9 measures depression with scores of 5-9, 10-14,15-19 and 20 or higher representing mild, moderate , moderate to severe and severe depression. PHQ-9 scores will be performed on all patients to determine the level of depression among patients prescribed tramadol.
Baseline
General Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline
GAD-7 measures anxiety with scores of 5, 10 and 15 representing mild, moderate and severe anxiety. GAD-7 scores will be performed on all patients to determine the level of anxiety among patients prescribed tramadol.
Baseline
Opioid Risk Tool (ORT)
Time Frame: Baseline
ORT measures the risk of future opioid abuse. A score of equal or less than 3 correlates with a low risk of opioid abuse. Scores of 4 to 7 indicates moderate risk and scores above 8 represents high risk.ORT scores will be performed on all patients to determine the risk of future opioid misuse among patients prescribed tramadol.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Anticipated)

July 31, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 21, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 21, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202007-00107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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