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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
Must not have
Narrow angle glaucoma
Active suicidal ideation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 13 of treatment phase, week 25 of treatment phase
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with narrow angle glaucoma.
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I am currently having thoughts about harming myself.
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My kidneys are not working well (creatinine clearance <30).
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I am currently taking duloxetine.
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I have an inflammatory condition like lupus or ankylosing spondylitis.

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

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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?

National Institute of Nursing Research (NINR)NIH
606 Previous Clinical Trials
10,378,371 Total Patients Enrolled
22 Trials studying Chronic Pain
3,062 Patients Enrolled for Chronic Pain
Wake Forest University Health SciencesLead Sponsor
1,403 Previous Clinical Trials
2,477,990 Total Patients Enrolled
15 Trials studying Chronic Pain
797 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
~71 spots leftby Jan 2026
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