Clinical trial NCT01038323
Conditions: Fibromyalgia
Keywords: Fibromyalgia FMS
Sponsor: Indiana University
Start date: 2009-12-01; Completion date: 2012-09-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Fibromyalgia Syndrome (FMS) afflicts 2% of the U.S. population and have huge individual and societal costs in terms of quality of life, social and work functioning, health care use, and lost productivity. Although single therapy approaches such as medication, graduated exercise, and Cognitive Behavioral Therapy (CBT) are well-established treatment approaches, the majority of FMS continue to report significant levels of pain and pain-related disability. Testing the efficacy of using combination therapies such and CBT with medication has considerable potential to maximize treatment response. Also, exploring the biological and psychological mechanisms underlying combination treatment may pave the way for developing new treatments for FMS sufferers.

We chose to study drug and CBT for several reasons: 1) the scarcity of trials that manipulate medications along with CBT in FMS, 2) the prohibitive nature of adding an exercise treatment arm in a study that has both time and budgetary constraints, 3) the complexity in understanding the mechanism of actions of 3 different modes of intervention in one clinical trial, and 4) the desire to explore mechanisms in this program of research, in particular the potential effects of a biological intervention (drug) on what is traditionally considered a psychological outcome (pain-related attributions and cognition) and the potential effects of a psychological intervention (CBT) on what is traditionally considered a physiological outcome (pain sensitivity).

Detailed description:
Qualified participants will take part in a 21-week clinical research study entitled, "Drug and Talk Therapy for Fibromyalgia". We are doing this study to better understand how talk therapies, such as education and cognitive behavioral therapy (CBT), can improve the therapeutic benefits of drug for fibromyalgia.

Savella ®, (milnacipran) is an FDA approved drug for fibromyalgia. The safety and efficacy of Savella has been established in two US-based clinical studies involving over 2,000 patients with fibromyalgia. Because Savella has already been shown to be effective when used in isolation to treat fibromyalgia, we are conducting the study to determine whether combination treatment (Savella + talk therapy) is more efficacious than just Savella alone or talk therapy alone.

Volunteers will be randomized (like flipping a coin) on two different levels:

1. Each participate will be randomized into one of two groups for medication:

   One group will receive Savella and the other group will receive a placebo (no medicinal value). Both the medication and the placebo will look identical and subjects will not be told into which group they have been placed until the completion of the study. Each participants has 66% chance of receiving Savella and 34% chance of getting the placebo.
2. The second level of randomization will be to determine which type of talk therapies you will be assigned to. Subjects will be randomly assigned to receive educational instruction relevant to fibromyalgia, OR cognitive behavioral therapy which includes a workbook. Both talk therapies will be provided over the phone once a week for 8 weeks. Each phone session may last for 30 minutes. Importantly, both talk therapies can provide coping tools and information designed to help manage fibromyalgia symptoms.

Study Overview:

Subjects will be asked to visit the Fibromyalgia Clinical Research Center on five separate occasions: Initial Screening (today's visit), Week 1, Week 2, Week 9, and Week 21.

VISIT 1:

1. Informed consent and initial screening questionnaire,physical assessment
2. Issue a 'pain score' wrist monitor with instructions to record current pain level three times a day for one week

VISIT 2:

1. Submit your pain recording
2. Complete the self-assessment questionnaires via computer
3. Vital signs check
4. Undergo pain sensitivity testing
5. If qualified, subjects be randomized to receive Savella or placebo AND to receive education or cognitive behavioral therapy

VISIT 3:

1. We will assess the subject's willingness to continue participation.
2. Review medication diary and medication side-effect checklist.
3. Schedule PHONE Therapy sessions: 8 thirty minute calls

VISIT 4:

1. One week prior to this visit, subjects will receive a 'pain score' monitor in order to enter current pain levels three times a day for one week. Then report for this visit.
2. Review side effect checklist, medication diary.
3. Completion of self-assessment questionnaires via computer
4. Undergo pain sensitivity testing

VISIT 5:

1. One week prior to this visit, subjects will receive a 'pain score' monitor in order to enter current pain levels three times a day for one week. Then report for this visit.
2. Review side effect checklist, medication diary.
3. Completion of self-assessment questionnaires via computer
4. Undergo pain sensitivity testing
5. Upon visit completion, participants will receive a reduced dose regimen of the medication along with written and verbal instructions to safely discontinue the study medication.

Arms: arm 1: Subjects randomized to this group will receive a combination of eight telephone sessions of Cognitive Behavior Therapy (CBT) and a 21-week regimen of milnacipran. arm 2: Subjects randomized to this arm will receive a series of eight telephone sessions of Cognitive Behavioral Therapy (CBT) along with a 21-week regimen of a placebo(sugar pill)medication. arm 3: Subjects randomized to this group will receive a series of eight educational phone calls regarding fibromyalgia along with a 21-week regimen of milnacipran.
Interventions: intervention 1: CBT and milnacipran intervention 2: CBT with a placebo intervention 3: Educational with milnacipran
Intervention descriptions: intervention 1: Participants will receive a series of eight telephone sessions of CBT along with a 21-week regimen of milnacipran. Dosing for milnacipran begins with a one week "starter pack". Dosage:12.5 mg on day 1,12.5 mg twice daily on days 2 and 3, then 25 mg twice daily on days 4,5,6,and 7. On day 8 participants will begin taking 50 mg twice daily for the balance of the study. intervention 2: Participants will receive a series of eight telephone sessions of CBT along with a 21-week regimen of a placebo. Dosing for the placebo begins with a one week "starter pack". Dosage: 12.5 mg on day 1,12.5 mg twice daily on days 2 and 3, then 25 mg twice daily on days 4,5,6,and 7. On day 8 participants will begin taking 50 mg twice daily for the balance of the study. intervention 3: Participants will receive a series of eight telephone sessions of fibromyalgia related education along with a 21-week regimen of milnacipran. Dosing for milnacipran begins with a one week "starter pack". Dosage:12.5 mg on day 1,12.5 mg twice daily on days 2 and 3, then 25 mg twice daily on days 4,5,6,and 7. On day 8 participants will begin taking 50 mg twice daily for the balance of the study.

Protocol documents: