The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold

Northwestern University

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Procedure: Intervention 2; Behavioral: Washout Period; Procedure: Intervention 1

Study type: Interventional

Funder types: Other

Identifiers

NCT02550093

STU86297

Details and patient eligibility

About

Oxytocin is neurohypophysial peptide that acts mainly as a neuromodulator in the brain.The vast majority of basic science studies suggested a large effect of oxytocin in minimizing acute pain.Few studies have demonstrated an association between plasma levels of oxytocin and pain in humans. Since addictive properties of oxytocin have not been described, the drug may have important application in the management of acute and chronic pain. No studies have examined the effect of intranasal oxytocin on pain sensitivity and threshold.

Enrollment: 20 patients

Sex: All

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males and females volunteers, English speaking

Exclusion criteria

• Pregnancy, lactation, allergy to preservatives, mental disease, any chronic pain and any current use of analgesics, anxiety or depression.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Oxytocin, then Normal Saline

Experimental group

Description:

Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of Oxytocin prior to Thermal Evaluation System Testing on intervention 1 (day 1). Following a wash-out period of 13 days the same subject will then receive a nasal spray(s) into each nostril of 4 Units up to 32 units of Normal Saline prior to Thermal Evaluation System Testing on intervention 2 (day 14).

Treatment:

Procedure: Intervention 1

Behavioral: Washout Period

Procedure: Intervention 2

Normal Saline, then Oxytocin

Experimental group

Description:

Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of Normal Saline prior to Thermal Evaluation System Testing on intervention 1 (day 1). Following a wash-out period of 14 to 15 days the same subject will then receive nasal spray(s) into each nostril of 4 Units up to 32 units of Oxytocin prior to Thermal Evaluation System Testing on intervention 2 (day 14).

Treatment:

Procedure: Intervention 1

Behavioral: Washout Period

Procedure: Intervention 2