A Multi-centre Survey on Tramadol Abuse in Singapore

Opioid Abuse Clinical Trial

Official title:

A Multi-centre Survey on Tramadol Abuse in Singapore

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04813458
• Other study ID #: 202007-00107
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: March 2021
• Source: Singapore General Hospital
• Contact: Christopher Liu
• Phone: +6582181062
• Email: christopher.liu.w.y[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 1, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients attending pain clinic in Singapore General Hospital, Seng Kang General Hospital and Changi General Hospital Exclusion Criteria: -

Related Conditions & MeSH terms

• Opioid Abuse
• Opioid-Related Disorders

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore
Singapore	Seng Kang General Hospital	Singapore
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Health Questionnaire-9 (PHQ-9)	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
Secondary	General Anxiety Disorder-7 (GAD-7)	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
Secondary	Opioid Risk Tool (ORT)	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