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| Name | Class |
|---|---|
| Yale University | OTHER |
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The study aim is to evaluate potential analgesic properties of ketum using the cold pressor task.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketum | Experimental | 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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| Placebo | Placebo Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketum | Drug | Ketum (Mitragyna speciosa) is an indigenous plant of Southeast Asia reported to have medicinal value in traditional culture |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain tolerance | The duration (seconds) participants can keep their hands immersed in the water bath | 3 hours |
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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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohd Bazlan Hafidz Mukrim, BSc | Contact | 609-7672354 | 2362 | bazlan@usm.my |
| Name | Affiliation | Role |
|---|---|---|
| Vicknasingam Kasinather, PhD | Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Drug Research, Univerisiti Sains Malaysia | Recruiting | George Town | Pulau Pinang | 11800 | Malaysia |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C001801 | mitragynine |
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Within-subject, repeated measures
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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.
| Placebo | Drug | Placebo drink matched for taste and appereance |
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