Actively Recruiting
Kratom Use Disorder Management Using Clonidine and/or Buprenorphine Observational Study of Withdrawal Treatment with Rotational Medication Assessment of Opiate Withdrawal Symptoms Over 12 Weeks
Led by Salem Anaesthesia Pain Clinic · Updated on 2025-01-27
50
Participants Needed
1
Research Sites
391 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Kratom is a herb used for stimulant, pain relief, anxiety reduction, and sedation effects. There is limited knowledge about Kratom addiction and withdrawal treatment. This research evaluates management approaches for Kratom withdrawal by using medicines typically applied for opioid withdrawal. The study follows a prospective observational crossover design involving adult patients undergoing Kratom withdrawal treatment. Participants receive different treatments on alternating weeks: a Buprenorphine 5 mcg/hr patch alone, Clonidine tablets 0.1 mg every 4 hours alone, or a combination of both Buprenorphine patch and Clonidine tablets. Each treatment phase lasts 12 continuous weeks. Participants will record their withdrawal symptoms daily using the Subjective Opiate Withdrawal Scale (SOWS), a patient-reported tool. Physicians will assess withdrawal signs weekly using the Clinical Opiate Withdrawal Scale (COWS), a clinician-administered tool. Changes of 6 points on either scale are considered significant. Data analysis includes statistical tests to evaluate treatment effects and withdrawal severity over 12 weeks.
CONDITIONS
Official Title
Kratom Use Disorder Management Using Clonidine and/or Buprenorphine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients
- Diagnosis of Kratom dependence
- Experiencing Kratom withdrawal syndrome
- Undergoing Kratom withdrawal therapy
- Good compliance with treatment
- Able to reliably complete Subjective Opiate Withdrawal Scale (SOWS) diary
- Able to reliably complete Clinical Opiate Withdrawal Scale (COWS) diary
- Provided informed consent for diary review
- Provided consent for clinical record quality assurance review
You will not qualify if you...
- Poor compliance with treatment
- Cognitive disorder
- Unable to provide informed consent
- Major neuropsychiatric disorder
- Unreliable diary completion
- Cannabis use
- Excessive alcohol intake
- Previous adverse or allergic reactions to clonidine
- Previous adverse or allergic reactions to buprenorphine
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Salem Anaesthesia Pain Clinic
Surrey, British Columbia, Canada, V3S 7J1
Actively Recruiting
Research Team
O
Olu Bamgbade, MD,FRCPC
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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