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Ketum and Pain Tolerence

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ClinicalTrials.gov Identifier: NCT03414099
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : April 28, 2021
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Vicknasingam B Kasinather, Universiti Sains Malaysia

Study Description
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Brief Summary:
The study aim is to evaluate potential analgesic properties of ketum using the cold pressor task.

Condition or disease Intervention/treatment Phase
Pain Drug: Ketum Drug: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Within-subject, repeated measures
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Ketum and placebo drinks will be matched for taste and appearence. Each study participant will receive a sequence of ketum and placebo drinks in random order.
Primary Purpose: Other
Official Title: Ketum and Pain Tolerence
Actual Study Start Date : January 23, 2018
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021
Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Pain tolerance [ Time Frame: 3 hours ]
    The duration (seconds) participants can keep their hands immersed in the water bath


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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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.

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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414099


Contacts
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Contact: Mohd Bazlan Hafidz Mukrim, BSc 609-7672354 ext 2362 bazlan@usm.my

Locations
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Malaysia
Centre for Drug Research, Univerisiti Sains Malaysia Recruiting
George Town, Penang, Malaysia, 11800
Contact: Vicknasingam Kasinather, PhD    604653272    vickna@usm.my   
Principal Investigator: Vicknasingam Kasinather, PhD         
Principal Investigator: Marek C Chawarski, PhD         
Sponsors and Collaborators
Universiti Sains Malaysia
Yale University
Investigators
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Principal Investigator: Vicknasingam Kasinather, PhD Director
More Information
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Responsible Party: Vicknasingam B Kasinather, Professor, Universiti Sains Malaysia
ClinicalTrials.gov Identifier: NCT03414099    
Other Study ID Numbers: USM/JEPeM/17050243
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Vicknasingam B Kasinather, Universiti Sains Malaysia:
Pain
Kratom
Ketum
mitragynine