Fenobam on Heat/Capsaicin Induced Hyperalgesia in Healthy Volunteers
Completed · Phase 1 · Has a placebo group
Conditions studied: Hyperalgesia, Allodynia
In brief
Our goal is to demonstrate that healthy volunteers treated with fenobam will develop a significantly reduced area of cutaneous hyperalgesia compared to volunteers treated with placebo, after exposure to the heat/capsaicin model of cutaneous sensitization. Additionally we are going to assess changes in mood/affect and cognitive function of subjects following administration of fenobam and after cutaneous sensitization compared to baseline.
Key facts
- Study ID
- NCT01981395
- Run by
- Laura Cavallone
- People needed
- 33
- Starts
- 2014-01-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2016-04-29
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 18-50 year old
- Good general health with no remarkable medical conditions (e.g. liver, kidney, heart, or lung failure)
- BMI between 20-33
- Willing to comply with study guidelines as outlined in protocol [including: women of childbearing age must be willing to use a double-barrier method (e.g. oral contraception and condom) for contraception during participation in the study]
- Willing to provide informed consent
You may not qualify if…
- Anatomical malformation of upper extremities
- Status post recent trauma or chronic lesions on either forearm
- Medication use (includes vitamin, herbal, dietary and mineral supplements and grapefruit products during or within 14 days prior to study participation; excludes contraceptives)
- History of allergy or intolerance to capsaicin
- History of multiple drug allergies
- History of addiction to drugs or alcohol (prior or present addiction or treatment for addiction)
- History of chronic pain syndromes
- Pregnant and nursing females
- Smokers
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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