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Ketum and Pain Tolerence

Ketum and Pain Tolerence

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03414099
Enrollment
20
Registered
2018-01-29
Start date
2018-01-23
Completion date
2021-12-30
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Pain, Kratom, Ketum, mitragynine

Brief summary

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

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.

Interventions

DRUGKetum

Ketum (Mitragyna speciosa) is an indigenous plant of Southeast Asia reported to have medicinal value in traditional culture

DRUGPlacebo

Placebo drink matched for taste and appereance

Sponsors

Yale University
CollaboratorOTHER
Universiti Sains Malaysia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, 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.

Intervention model description

Within-subject, repeated measures

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain tolerance3 hoursThe duration (seconds) participants can keep their hands immersed in the water bath

Countries

Malaysia

Contacts

Primary ContactMohd Bazlan Hafidz Mukrim, BSc
bazlan@usm.my609-7672354

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026