CClinicalTrials.gg
Status unknownNCT03414099Updated Apr 28, 2021

Ketum and Pain Tolerence

An interventional study of Ketum and Placebo in Pain, sponsored by Universiti Sains Malaysia. Status unknown at 1 site in Malaysia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-28.

Sponsored by Universiti Sains Malaysia · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Pain

Keywords

  • Pain
  • Kratom
  • Ketum
  • mitragynine
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.

-

04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugKetum

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

    Also known as: Kratom

  • DrugPlacebo

    Placebo drink matched for taste and appereance

05

What researchers measure

Primary outcomes

  1. Pain tolerance

    The duration (seconds) participants can keep their hands immersed in the water bath

    Time frame: 3 hours

06

Study locations

1 of 1 sites recruiting
  • Centre for Drug Research, Univerisiti Sains Malaysia
    George Town, Penang 11800, Malaysia
    • Vicknasingam Kasinather, PhD · Contact · vickna@usm.my · 604653272
    • Vicknasingam Kasinather, PhD · Principal investigator
    • Marek C Chawarski, PhD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03414099
Lead sponsor
Universiti Sains Malaysia
Collaborators
Yale University
Responsible party
Vicknasingam B Kasinather (Professor, Universiti Sains Malaysia) — Principal investigator
First posted
Jan 29, 2018
Start date
Jan 23, 2018
Primary completion
Dec 30, 2021 (estimated)
Completion
Dec 30, 2021 (estimated)
Last update
Apr 28, 2021

Study contacts

Mohd Bazlan Hafidz Mukrim, BSc
Contact
bazlan@usm.my
609-7672354 ext. 2362
Vicknasingam Kasinather, PhD
principal investigator · Director

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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