Ketum and Pain Tolerence

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

Detailed Description
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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.

Official Title
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Ketum and Pain Tolerence

Conditions
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Pain

Intervention / Treatment
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* Drug: Ketum
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Within-subject, repeated measures
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketum<br>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<br>* Ketum (Mitragyna speciosa) is an indigenous plant of Southeast Asia reported to have medicinal value in traditional culture<br>* Other names: Kratom;|
| Placebo Comparator: Placebo<br>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<br>* Placebo drink matched for taste and appereance<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Kratom, Ketum, mitragynine