Ketum and Pain Tolerence

Sponsor

Universiti Sains Malaysia (Other)

Overall Status

Recruiting

CT.gov ID

NCT03414099

Collaborator

Yale University (Other)

Enrollment

Location

Arms

47.2

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Ketum Drug: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Within-subject, repeated measuresWithin-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 :

Jan 23, 2018

Anticipated Primary Completion Date :

Dec 30, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
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 Ketum (Mitragyna speciosa) is an indigenous plant of Southeast Asia reported to have medicinal value in traditional culture Other Names: 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.	Drug: Placebo Placebo drink matched for taste and appereance

Arm

Intervention/Treatment

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

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

Other Names:

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.

Drug: Placebo

Placebo drink matched for taste and appereance

Outcome Measures

Primary Outcome Measures

Pain tolerance [3 hours]
The duration (seconds) participants can keep their hands immersed in the water bath

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Drug Research, Univerisiti Sains Malaysia	George Town	Penang	Malaysia	11800

Sponsors and Collaborators

Universiti Sains Malaysia
Yale University

Investigators

Principal Investigator: Vicknasingam Kasinather, PhD, Director

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vicknasingam B Kasinather, Professor, Universiti Sains Malaysia

ClinicalTrials.gov Identifier:

NCT03414099

Other Study ID Numbers:

USM/JEPeM/17050243

First Posted:

Jan 29, 2018

Last Update Posted:

Apr 28, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Vicknasingam B Kasinather, Professor, Universiti Sains Malaysia

Study Results

No Results Posted as of Apr 28, 2021