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
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Condition or disease | Intervention/treatment | Phase |
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Pain | Drug: Ketum Drug: Placebo | Not Applicable |
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 |
Arm | Intervention/treatment |
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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.
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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.
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Drug: Placebo
Placebo drink matched for taste and appereance |
- Pain tolerance [ Time Frame: 3 hours ]The duration (seconds) participants can keep their hands immersed in the water bath

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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 |
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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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
Contact: Mohd Bazlan Hafidz Mukrim, BSc | 609-7672354 ext 2362 | bazlan@usm.my |
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 |
Principal Investigator: | Vicknasingam Kasinather, PhD | Director |
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 |
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 |
Pain Kratom Ketum mitragynine |