A Multi-centre Survey on Tramadol Abuse in Singapore

Sponsor
Singapore General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04813458
Collaborator
(none)
1,000
3
8
333.3
41.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    A Multi-centre Survey on Tramadol Abuse in Singapore
    Actual Study Start Date :
    Dec 1, 2020
    Anticipated Primary Completion Date :
    Jul 31, 2021
    Anticipated Study Completion Date :
    Aug 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Current Opioid Misuse Measure (COMM) [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)

    Secondary Outcome Measures

    1. Patient Health Questionnaire-9 (PHQ-9) [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.

    2. General Anxiety Disorder-7 (GAD-7) [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.

    3. Opioid Risk Tool (ORT) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • All patients attending pain clinic in Singapore General Hospital, Seng Kang General Hospital and Changi General Hospital
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Changi General Hospital Singapore Singapore
    2 Seng Kang General Hospital Singapore Singapore
    3 Singapore General Hospital Singapore Singapore

    Sponsors and Collaborators

    • Singapore General Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Singapore General Hospital
    ClinicalTrials.gov Identifier:
    NCT04813458
    Other Study ID Numbers:
    • 202007-00107
    First Posted:
    Mar 24, 2021
    Last Update Posted:
    Mar 24, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 24, 2021