Ketum and Pain Tolerence

April 26, 2021 updated by: Vicknasingam B Kasinather, Universiti Sains Malaysia
The study aim is to evaluate potential analgesic properties of ketum using the cold pressor task.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants in the proposed study will be individuals who report consuming ketum more than once a day, daily for the past 12 months. The study is a placebo-controlled, double-blind within-subject repeated mesaures design. Participants will ingest a sequence of ketum and placebo drinks prepared by pharmacologists at USM Centre for Drug Research and their pain tolerance will be measured by the cold pressor task after ingesting ketum or placebo.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mohd Bazlan Hafidz Mukrim, BSc
  • Phone Number: 2362 609-7672354
  • Email: bazlan@usm.my

Study Locations

  • Malaysia
    • Penang
      • George Town, Penang, Malaysia, 11800
        • Recruiting
        • Centre for Drug Research, Univerisiti Sains Malaysia
        • Contact:
          • Vicknasingam Kasinather, PhD
          • Phone Number: 604653272
          • Email: vickna@usm.my
        • Principal Investigator:
          • Vicknasingam Kasinather, PhD
        • Principal Investigator:
          • Marek C Chawarski, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria: Individuals who report drinking ketum decoction more than once a day, daily for the past 12 months.

-

Exclusion Criteria: (1) tested positive for illicit drug use including morphine, cannabis, methamphetamine, amphetamine, methadone, benzodiazepine and ketamine; (2) have current or previous history of psychological or neurological problems (self-report); (3) have current or previous alcohol use history (self-report); (4) HIV infections; (5) history of chronic liver disease (e.g. cirrhosis, hepatitis A, B, C, etc.) 6) non-alcoholic fatty liver disease; (7) history of coronary heart disease and diabetes; (8) existing chronic pain condition and (9) history of psychiatric disorders. Exclusion criteria for female particiapns: (1) pregnancy, (2) nursing.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketum
Each participant will consume a sequence of active ketum or placebo drinks. Pain tolerance will be measured using the cold pressor task after consuming each drink.
Drug: Ketum
Ketum (Mitragyna speciosa) is an indigenous plant of Southeast Asia reported to have medicinal value in traditional culture
Other Names:
  • Kratom
Placebo Comparator: Placebo
Each participant will consume a sequence of active ketum or placebo drinks. Pain tolerance will be measured using the cold pressor task after consuming each drink.
Drug: Placebo
Placebo drink matched for taste and appereance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain tolerance
Time Frame: 3 hours
The duration (seconds) participants can keep their hands immersed in the water bath
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Sains Malaysia

Collaborators

Yale University

Investigators

  • Principal Investigator: Vicknasingam Kasinather, PhD, Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2018

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

January 22, 2018

First Submitted That Met QC Criteria

January 22, 2018

First Posted (Actual)

January 29, 2018

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • USM/JEPeM/17050243

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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