NCT04813458

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

March 10, 2021

Last Update Submit

March 21, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Current Opioid Misuse Measure (COMM)

    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 Outcomes (3)

  • Patient Health Questionnaire-9 (PHQ-9)

    Baseline

  • General Anxiety Disorder-7 (GAD-7)

    Baseline

  • Opioid Risk Tool (ORT)

    Baseline

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Changi General Hospital

Singapore, Singapore

RECRUITING

Seng Kang General Hospital

Singapore, Singapore

RECRUITING

Singapore General Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 24, 2021

Study Start

December 1, 2020

Primary Completion

July 31, 2021

Study Completion

August 1, 2021

Last Updated

March 24, 2021

Record last verified: 2021-03

Locations