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NCT Number: NCT05883358

Kratom Use Disorder Management Using Clonidine and/or Buprenorphine

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.

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Key information

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Salem Anaesthesia Pain Clinic

Surrey, British Columbia, V3S 7J1, Canada

Location status: Recruiting

Location contact

Olu Bamgbade, MD,FRCPC

CONTACT

[email protected]

+17786286600

About this study

Kratom herb is used for stimulant, analgesic, anxiolytic, and sedative effects. There is inadequate knowledge about Kratom dependence and withdrawal therapy. Kratom withdrawal may be treated with similar therapy for opioid withdrawal.

This is a prospective observational crossover study of consenting adult patients who are undergoing Kratom withdrawal management. On alternate weeks, each patient receives rotational 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 Kratom withdrawal treatment for 12 continuous weeks.

The patient will use the Subjective Opiate Withdrawal Scale (SOWS), a special validated scale, to collect data on daily basis. The SOWS is a patient-administered tool that is used to record the severity and presence of opiate withdrawal symptoms. In addition, the physician will use the Clinical Opiate Withdrawal Scale (COWS), a special validated scale, to collect data on weekly basis. The COWS is a clinician-administered tool that is used to record the symptoms and signs of opiate withdrawal or substance abuse disorder. A change in the COWS and SOWS scores by 6-points is considered significant.

Data analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value <0.05 is considered significant.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Clonidine, Buprenorphine

Drug

Each patient receives rotational treatment using Buprenorphine 5cmg/hr patch; or Clonidine tablet 0.1mg 4hourly; or combined Clonidine tablet 0.1mg 4hourly + Buprenorphine 5cmg/hr patch.

Other names: Clonidine, Butrans

Primary outcomes

  1. Clinical Opiate Withdrawal Score

    Time frame: 12 weeks

    Clinical Opiate Withdrawal Score on a scale of 5 to 36; low scores indicate mild withdrawal, high scores indicate severe withdrawal

Study contacts

Contact information is provided by the study sponsor or research team.

Olu Bamgbade, MD,FRCPC

CONTACT

[email protected]

17786286600

Sponsors and collaborators

Lead sponsor

Salem Anaesthesia Pain Clinic

Other

Registry information

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
May 31, 2023
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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