Ketum and Pain Tolerence
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Universiti Sains Malaysia
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Pain tolerance
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- 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.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
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.
Intervention: Ketum (Drug)
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.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Pain tolerance
Time Frame: 3 hours
The duration (seconds) participants can keep their hands immersed in the water bath
Secondary Outcomes
No secondary outcomes reported
Investigators
Vicknasingam B Kasinather
Professor
Universiti Sains Malaysia