Overview

Fenobam on Heat/Capsaicin Induced Hyperalgesia in Healthy Volunteers

Status:
Completed

Trial end date:
2016-04-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Laura Cavallone

Treatments:

Capsaicin

Criteria

Inclusion Criteria:

1. 18-50 year old

2. Good general health with no remarkable medical conditions (e.g. liver, kidney, heart,
or lung failure)

3. BMI between 20-33

4. 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]

5. Willing to provide informed consent

Exclusion Criteria:

1. Anatomical malformation of upper extremities

2. Status post recent trauma or chronic lesions on either forearm

3. Medication use (includes vitamin, herbal, dietary and mineral supplements and
grapefruit products during or within 14 days prior to study participation; excludes
contraceptives)

4. History of allergy or intolerance to capsaicin

5. History of multiple drug allergies

6. History of addiction to drugs or alcohol (prior or present addiction or treatment for
addiction)

7. History of chronic pain syndromes

8. Pregnant and nursing females

9. Smokers