Kratom Use Disorder Management Using Clonidine and/or Buprenorphine

ConditionWithdrawal Syndrome

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age20-99

SponsorSalem Anaesthesia Pain Clinic

About this trial

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

This trial accepts healthy volunteers

Qualifiers

adult patients

Kratom dependence

Kratom withdrawal syndrome

Kratom withdrawal therapy

Disqualifiers

poor treatment compliance

cognitive disorder

inability to provide consent

major neuropsychiatric disorder

Trial population

Adult patients who have Kratom withdrawal syndrome; and undergoing medication treatment for Kratom withdrawal.

Trial design

Design model

Case-crossover

Time perspective

Prospective

Treatments tested in this trial

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.

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Kratom withdrawal1 intervention

Trial outcomes

Primary outcomes

Clinical Opiate Withdrawal Score

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

Time frame

12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Salem Anaesthesia Pain Clinic

Lead sponsor

Source ClinicalTrials.gov

Apply now