Kratom Use Disorder Management Using Clonidine and/or Buprenorphine

Last updated: January 23, 2025
Sponsor: Salem Anaesthesia Pain Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Clonidine, Buprenorphine

Clinical Study ID

NCT05883358
SalemAnes2022 Kratom Addiction
  • Ages 20-99
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Clonidine, Buprenorphine
Phase:
Study Start date:
July 02, 2018
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • Salem Anaesthesia Pain Clinic

    Surrey, British Columbia V3S 7J1
    Canada

    Active - Recruiting

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