Conditions: Healthy
Keywords: Cold pain methodology Healthy male volunteers gabapentin Diphenhydramine morphine
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 19
Healthy volunteers: yes

Brief summary:
Human experimental pain models are useful in understanding the mechanisms underlying clinical pain conditions and can be used to test the analgesic efficacy of drugs used in the management of pain. Once established these models can be used as mechanism biomarkers in early development clinical studies to establish proof of mechanism for novel compounds. The cold pain model is a mechanistic pain biomarker with potential application in proof of mechanism studies. In this study we aim to set up this cold pain model at a Clinical Research Unit and demonstrate we can effectively screen subjects for this model and examine the effect of morphine, diphenhydramine, and gabapentin in the cold pain model.

Detailed description:
Cold pain methodology development

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Gabapentin intervention 2: Diphenhydramine intervention 3: Morphine intervention 4: Placebo
Intervention descriptions: intervention 1: Capsule, single 1200mg dose intervention 2: Tablet, single 50mg dose intervention 3: IV, single 10mg dose intervention 4: Placebo formulations (Capsule, tablet, IV to match the active treatments and to be administered in a double-dummy fashion).

Protocol document: