Ketum and Pain Tolerence

Not Applicable

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Ketum

• Registration Number: NCT03414099
• Lead Sponsor: Universiti Sains Malaysia

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.

Study Timeline

• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-01-22
• Study Start: 2018-01-23
• Study First Posted: 2018-01-29
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-28
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Ketum	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.

Primary Outcome Measures

Name	Time	Method
Pain tolerance	3 hours	The duration (seconds) participants can keep their hands immersed in the water bath

Trial Locations

Locations (1)

Centre for Drug Research, Univerisiti Sains Malaysia; 🇲🇾 George Town, Penang, Malaysia