Drug and Talk Therapy for Fibromyalgia

NCT01038323 | Completed Phase 4 Results DMC

• 2 other identifiers: IU 0904-081R21AR056046-01A2
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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).

Conditions

Fibromyalgia

Keywords

Fibromyalgia; FMS

Outcome Measures

Primary Outcomes (1)

• Change in Weekly Average Pain Intensity

  Change in weekly average pain intensity score from baseline to week 21 (scale from -10 to +10; the more negative the value, the better in terms of pain reduction)

  Baseline and Week 21clinic visits

Secondary Outcomes (2)

• Change in Evoked Pain Scores

  Baseline and Week 21 clinic visits

• Identification of Group Assignment

  week 21

Study Arms (3)

CBT and milnacipran

EXPERIMENTAL

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.

Other: CBT and milnacipran

CBT and placebo

PLACEBO COMPARATOR

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.

Behavioral: CBT with a placebo

Educational with milnacipran

ACTIVE COMPARATOR

Subjects randomized to this group will receive a series of eight educational phone calls regarding fibromyalgia along with a 21-week regimen of milnacipran.

Drug: Educational with milnacipran

Interventions

CBT and milnacipran OTHER

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.

Also known as: milnacipran, Savella, Cognitive Behavioral Therapy, CBT, fibromyalgia

CBT and milnacipran

CBT with a placebo BEHAVIORAL

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.

Also known as: placebo, sugar pills, Cognitive Behavioral Therapy, CBT, fibromyalgia

CBT and placebo

Educational with milnacipran DRUG

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.

Also known as: fibromyalgia, fibromyalgia education, milnacipran, Savella

Educational with milnacipran

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be between the ages of 18 to 65 years of age
• Must have been diagnosed with fibromyalgia by a rheumatologist
• Must have an overall body pain average score ≥ 4
• Must be on stable doses of your current medication for at least past four weeks
• Must report all medication including herbal supplements and over-the-counter medications that you are currently taking to a member of the research team.
• Must limit any changes in your medication(s)during the 21-week study time period unless medically necessary
• Must be willing to maintain a medication diary provided to you during the 21-week study period
• Must be willing to abstain (not take) any fibromyalgia related medication (including over-the-counter)for at least 6-hours prior to each of the three testing visits. (Otherwise, you may take these medication immediately after pain sensitivity testing has been completed and as prescribed in-between visits)
• Must experience the symptoms of fibromyalgia syndrome (FMS) that decreases (limits) your ability to perform daily activities.
• You have uncontrolled hypertension(high blood pressure) systolic \>160 mm Hg or diastolic blood pressure \> 100 mm Hg)
• If you have a history of: heart disease, glaucoma, or hepatitis
• You have been diagnosed with any type of peripheral neuropathy
• You have a body mass index (BMI) of more than 34
• You currently or frequently have thoughts of harming yourself or committing suicide.
• You are in the process of filing, or plan to file for disability benefits within the study timeline.

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Clinical Research Center for Pain, 250 University Blvd

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Ang DC, Jensen MP, Steiner JL, Hilligoss J, Gracely RH, Saha C. Combining cognitive-behavioral therapy and milnacipran for fibromyalgia: a feasibility randomized-controlled trial. Clin J Pain. 2013 Sep;29(9):747-54. doi: 10.1097/AJP.0b013e31827a784e.

  PMID: 23446065 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Milnacipran; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: dennis ang
• Organization: Wake Forest

dang@wakehealth.edu

336-716-4209

Study Officials

• Dennis C. Ang, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2009
• First Posted: December 23, 2009
• Study Start: December 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 6, 2017
• Results First Posted: July 21, 2016

Record last verified: 2017-01

Locations

US (1)