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Serotonin-Norepinephrine Reuptake Inhibitor

Combined Non-Opioid Intervention for Chronic Pain (PRECICE Trial)

Phase 4
Waitlist Available
Led By Dennis C Ang, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least moderate in BPI global pain severity
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 13 of treatment phase, week 25 of treatment phase
Awards & highlights

PRECICE Trial Summary

This trial will test if a non-opioid drug combined with web-based pain management skills training can help people with chronic pain.

Who is the study for?
This trial is for adults at a primary care clinic with chronic musculoskeletal pain in the low back, neck, hip, knee or widespread areas for over 3 months. They must have moderate pain severity and not be planning surgery during the study. Exclusions include uncontrolled high blood pressure, suicidal thoughts, unresolved disability claims, certain medical conditions like lupus or severe kidney issues, pregnancy, bipolar disorder or schizophrenia history.Check my eligibility
What is being tested?
The trial tests if combining duloxetine (a non-opioid medication) with web-based Cognitive Behavioral Therapy helps people cope better with chronic pain compared to usual treatments. Participants will receive motivational interviewing from nurses as part of their therapy.See study design
What are the potential side effects?
Duloxetine may cause nausea, dry mouth, sleepiness and constipation. Rarely it can increase blood pressure or lead to liver damage. Web-based CBT and motivational interviewing are generally safe but may bring up emotional discomfort initially.

PRECICE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I experience moderate to severe pain.

PRECICE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 13 of treatment phase, week 25 of treatment phase
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 13 of treatment phase, week 25 of treatment phase for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brief Pain Inventory (BPI)
Secondary outcome measures
Frequency of Practicing Pain Coping Skills
Generalized Anxiety Disorder 7-item scale (GAD-7)
Global Rating of Change
+14 more

Side effects data

From 2008 Phase 4 trial • 15 Patients • NCT00401258
60%
nausea
47%
insomnia
40%
constipation
27%
sedation
13%
dry mouth
13%
anorgasmia
13%
dizziness
13%
night sweats
13%
tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Duloxetine, 60 mg Daily

PRECICE Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: behavioral intervention, nurse support plus medicationExperimental Treatment3 Interventions
Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.
Group II: behavioral intervention plus medicationExperimental Treatment2 Interventions
Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).
Group III: medication onlyActive Control1 Intervention
Subjects randomized to this arm will receive duloxetine only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
duloxetine
2009
Completed Phase 4
~2320

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,240 Previous Clinical Trials
1,003,927 Total Patients Enrolled
13 Trials studying Chronic Pain
478 Patients Enrolled for Chronic Pain
Dennis C Ang, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

duloxetine (Serotonin-Norepinephrine Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04395001 — Phase 4
Chronic Pain Research Study Groups: behavioral intervention, nurse support plus medication, behavioral intervention plus medication, medication only
Chronic Pain Clinical Trial 2023: duloxetine Highlights & Side Effects. Trial Name: NCT04395001 — Phase 4
duloxetine (Serotonin-Norepinephrine Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04395001 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other endeavors have been undertaken showcasing the efficacy of duloxetine?

"Currently, 22 clinical trials studying duloxetine are in progress, 4 of which are classified as Phase 3. Most of the conducted research is located at Redwood City, California however there exist 781 other trial sites scattered around the world."

Answered by AI

What population is eligible for participation in this research endeavor?

"To qualify for this medical trial, patients must suffer from chronic pain and be within the age range of 18-65. Currently, 280 participants are needed to complete the study."

Answered by AI

What medical conditions is duloxetine commonly used to address?

"Duloxetine is a commonly prescribed medication for treating diabetic peripheral neuropathy, as well as knee pain, major depressive disorder (MDD), and musculoskeletal conditions."

Answered by AI

Is there availability for participants in this clinical trial?

"As indicated on clinicaltrials.gov, this study is presently searching for suitable participants. The experiment was initially posted in February 2021 and recently modified in March 2022."

Answered by AI

How deleterious are the effects of duloxetine for patients?

"There is extensive evidence suggesting the safety of duloxetine, thus it receives a rating of 3. This drug has been approved in Phase 4 trials and is available for public use."

Answered by AI

What is the upper limit for participants in this trial?

"Affirmative. According to the clinicaltrials.gov information, this experiment is currently enrolling patients and was originally posted on February 24th 2021. There have been recent modifications made on March 30th 2022 and 280 individuals are being recruited for 1 site."

Answered by AI

Is this medical trial open to elderly individuals?

"The boundaries for this medical investigation are 18 and 65 years old. 34 trails have been conducted with participants younger than the lower boundary, while 376 trials have encompassed individuals older than the upper bound."

Answered by AI

Who else is applying?

What site did they apply to?
Wake Forest Baptist Health Department of Rheumatology
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Pain Response Evaluation of a Combined Intervention to Cope Effectively
2021. "Pain Response Evaluation of a Combined Intervention to Cope Effectively". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04395001.
All > American Chronic Pain > Chronic Pain
~7 spots leftby Jun 2024
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