Recruiting

Clonidine & Buprenorphine

Sponsor:

Salem Anaesthesia Pain Clinic

Code:

NCT05883358

Conditions

Withdrawal Syndrome

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

Interventions

Clonidine, Buprenorphine

Study Details

Brief 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.

Conditions

Withdrawal Syndrome

Study ID

NCT05883358

Start date

Jul 2, 2018

Status verified date

Jan, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Kratom withdrawal

Kratom withdrawal syndrome patients, undergoing withdrawal therapy. 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.

Interventions

Clonidine, Buprenorphine

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.

Primary outcome measure

  • Clinical Opiate Withdrawal Score [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

Salem Anaesthesia Pain Clinic

Recruiting

Surrey, British Columbia, Canada, V3S 7J1

Contacts

More Information

Sponsor

Salem Anaesthesia Pain Clinic

Last update posted

Jan 27, 2025

Last verified

Jan, 2025

Keywords

  • Kratom

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Salem Anaesthesia Pain Clinic on 2025-01-27.