Actively Recruiting

Age: 20Years - 99Years
All Genders
Healthy Volunteers
NCT05883358

Kratom Use Disorder Management Using Clonidine and/or Buprenorphine

Led by Salem Anaesthesia Pain Clinic · Updated on 2025-01-27

50

Participants Needed

1

Research Sites

391 weeks

Total Duration

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AI-Summary

What this Trial Is About

Kratom is used for stimulant, analgesic, anxiolytic, and sedative effects. There is inadequate knowledge about Kratom addiction. Kratom withdrawal may be treated like opioid withdrawal. Prospective observational crossover study of consenting adults who are undergoing Kratom withdrawal management. On alternate weeks, each patient receives treatment using Buprenorphine 5cmg/hr patch; or Clonidine tablet 0.1mg 4hourly; or combined Clonidine tablet 0.1mg 4hourly + Buprenorphine 5cmg/hr patch. Each patient will undergo treatment for 12 weeks. Patients will use Subjective Opiate Withdrawal Scale (SOWS) to collect data on daily basis. SOWS is a patient-administered tool that is used to record the severity and presence of opiate withdrawal. The physician will also use Clinical Opiate Withdrawal Scale (COWS) to collect data on weekly basis. COWS is a clinician-administered tool that is used to record the signs of opiate withdrawal. A change in the COWS and SOWS scores by 6-points is considered significant.

CONDITIONS

Official Title

Kratom Use Disorder Management Using Clonidine and/or Buprenorphine

Who Can Participate

Age: 20Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Salem Anaesthesia Pain Clinic

Surrey, British Columbia, Canada, V3S 7J1

Actively Recruiting

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Research Team

O

Olu Bamgbade, MD,FRCPC

CONTACT

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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