Kratom Use Disorder Management Using Clonidine and/or Buprenorphine

Recruiting now

Conditions studied: Withdrawal Syndrome

In brief

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.

Key facts

Study ID

NCT05883358

Run by

Salem Anaesthesia Pain Clinic

People needed

50

Starts

2018-07-02

Expected to finish

2025-12-31

Last updated by the study team

2025-01-27

Who can join

Age: 20 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• adult patients
• Kratom dependence
• Kratom withdrawal syndrome
• Kratom withdrawal therapy
• good treatment compliance
• reliable Subjective Opiate Withdrawal Scale (SOWS) diary
• reliable Clinical Opiate Withdrawal Scale (COWS) diary
• informed consent for diary review
• consent for clinical record quality assurance review

You may not qualify if…

• poor treatment compliance
• cognitive disorder
• inability to provide consent
• major neuropsychiatric disorder
• unreliable diary
• cannabis use
• excessive alcohol intake
• previous adverse/allergic reactions to clonidine
• previous adverse/allergic reactions to buprenorphine

Where it is running

• Salem Anaesthesia Pain Clinic — Surrey, British Columbia, Canada (enrolling)

Full record on ClinicalTrials.gov

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