Brain Response to Pain Control in People With Chronic Pain

Different pain reducing drugs work in different ways to reduce pain. Many drugs, including
morphine and codeine, reduce pain by binding to opiate receptors in the brain. Another
chemical, naloxone, can block the effect of these drugs. In this study, we are looking at
brain responses to a pain-relieving cream and whether naloxone blocks the effect of the
cream. We will compare the results of people with chronic pain (fibromyalgia) to those of
people without chronic pain.

Design:

The study compares MRI response to painful stimulation between people with fibromyalgia and
healthy volunteers under two conditions: 1) naloxone, 2) placebo.

Outcome measures: Pain ratings and pain-related MRI responses are compared between people
with fibromyalgia and healthy volunteers

- INCLUSION CRITERIA:

Inclusion Criteria for Patients:

1. Patient must be greater than or equal to 18 years of age.

2. Patient must be able to comprehend English.

3. Patient must be able to provide written informed consent.

4. Patient must have had chronic widespread pain for at least one year prior to
participation with an average daily intensity at least 4 out of 10.

Inclusion Criteria for Healthy Controls:

1. Healthy control must be greater than or equal to 18 years of age

2. Healthy control must be able to comprehend English.

3. Healthy control must be able to provide written informed consent.

EXCLUSION CRITERIA:

Exclusion criteria for patients:

1. Patient is unable to comply with study procedures or follow-up visits

2. Patient smokes more than 10 cigarettes of nicotine per week.

3. Patient uses recreational drugs.

4. Female patient consumes more than 7 half-pint beers, 7 6-oz glasses of wine or 7 1-oz
shots of spirits (or equivalent) per week, and male patient consumes 14 such drinks
per week. Further, patient consumes more than 5 drinks at one time.

5. Patient is pregnant or breastfeeding.

6. Patient has a major medical condition, such as kidney, liver, cardiovascular,
neurological or current psychiatric condition.

7. Patient has currently or has had in the past major depression, bipolar disorder,
psychosis or suicide attempts.

8. Patient has metal in his/her body which would make having an MRI scan unsafe, such as
pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal
pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye
liner or small metal fragments in the eye that welders and other metal workers may
have.

9. Patient is uncomfortable in small closed spaces (has claustrophobia) so that he/she
would feel uncomfortable in the MRI machine.

10. Patient cannot lie comfortably flat on his/her back for up to 75 minutes in the MRI
scanner.

11. Patient has allergies to topical treatment.

12. Patient has a chronic pain condition other than FM.

13. Patient has taken within the last two weeks opioids. Other medications used to treat
fibromyalgia at the standard doses in the community can be taken. We will not ask
participants to stop any medication to participate in the study.

14. Patient has previously taken opioids for more than one month on a continual basis,
within the last 6 months.

15. Patient had seen study information on clinicaltrials.gov prior to September 23, 2013.

16. Patients who decline to be audio and/or videotaped will be excluded from the
qualitative interview component of the study.

Exclusion criteria for healthy controls:

1. Healthy control is unable to comply with study procedures or follow-up visits

2. Healthy control smokes more than 10 cigarettes of nicotine per week.

3. Healthy control uses recreational drugs.

4. Female healthy control consumes more than 7 half-pint beers, 7 6-oz glasses of wine or
7 1-oz shots of spirits (or equivalent) per week, and male healthy control consumes 14
such drinks per week. Further, healthy control consumes more than 5 drinks at one
time.

5. Healthy control is pregnant or breastfeeding.

6. Healthy control has a major medical condition, such as kidney, liver, cardiovascular,
neurological or current psychiatric condition.

7. Healthy control has currently or has had in the past major depression, bipolar
disorder, psychosis or suicide attempts.

8. Healthy control has metal in his/her body which would make having an MRI scan unsafe,
such as pacemakers, medication pumps, aneurysm clips, metallic prostheses (including
metal pins and rods, heart valves or cochlear implants), shrapnel fragments,