Brain Imaging and Pain: Analysis of Placebo Analgesia

University of Florida

Status and phase: Completed; Phase 1

Conditions: Brain Imaging of Placebo Analgesia

Treatments: Other: Control condition; Other: Placebo Instructions

Study type: Interventional

Funder types: Other

Identifiers

NCT01409538

R01 AT001424-05A

Details and patient eligibility

About

This study examines the brain activation associated with placebo pain reduction.

Full description

This study is a basic science study of the mechanisms of placebo analgesia in asymptomatic healthy individuals. Each participant receives a baseline pain testing session, followed by a conditioning paradigm that results in expectation of pain relief and conditioning. They then undergo functional magnetic resonance imaging during either placebo (conditioned analgesia) or baseline. To examine order effects and habituation, the participants also either undergo a repeated placebo or a repeated baseline. The primary dependent measures in the study are the fMRI determined regions of interest, in a network of brain areas associated with pain processing. The anticipated outcome of the study is the alteration of network connectivity between sensory, affective, evaluative areas of the brain associated with placebo.

Because this is not a traditional clinical trial, there are not traditional efficacy criteria, rather the outcomes are changes in brain function from manipulations of patient expectation and classical conditioning.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• at least 18 years of age
• english speaking

Exclusion criteria

• pain condition
• pregnant

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Asymptomatic control participants receive Natural History and Placebo instructions in a within-subject design. There are no patients, or active agents in this study. It is not a Clinical Trial.

Treatment:

Other: Placebo Instructions

Control condition

Active Comparator group

Description:

The control condition represents a no-intervention, repeated baseline control, since the "active" intervention in this study is placebo.

Treatment:

Other: Control condition