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Behavioral Intervention

Experimental for Chronic Pain

N/A
Recruiting
Led By Christina S McCrae, PhD
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Awards & highlights

Study Summary

This trial aims to test two different approaches to help people with chronic pain and insomnia who are taking opioid medication.

Who is the study for?
This trial is for people who have chronic pain and insomnia, and are currently using prescribed opioids. It aims to help them sleep better and reduce their opioid use.Check my eligibility
What is being tested?
The study is testing two approaches: one where patients continue their usual treatment, another where they gradually reduce opioid use (tapered withdrawal), and a third that uses Cognitive Behavioral Therapy for Insomnia (CBT-I).See study design
What are the potential side effects?
Possible side effects may include discomfort from changing medication routines or withdrawal symptoms in the tapered group, and typical therapy-related stress or anxiety with CBT-I.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Fatigue - Daily Electronic Sleep Diaries
Change in Insomnia Severity Index
Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging
+10 more
Secondary outcome measures
Change in Neural Connectivity: Structural/Functional MRI/Diffusion Weighted Imaging
Change in Objective Sleep Efficiency (Actigraph)
Change in Objective Sleep Onset Latency (Actigraph)
+3 more
Other outcome measures
Change in 36-Item Short Form Survey (SF-36)
Change in Depression (Beck Depression Inventory-II)
Change in NIH Toolbox
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment as usualExperimental Treatment2 Interventions
Continuation of standard treatment for sleep and pain for 8 weeks, followed by tapered withdrawal and motivational interviewing and check-ins.
Group II: ExperimentalExperimental Treatment2 Interventions
8 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment as usual
2010
N/A
~6760
CBT-I
2018
Completed Phase 2
~740

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,492 Previous Clinical Trials
2,622,891 Total Patients Enrolled
56 Trials studying Chronic Pain
83,065 Patients Enrolled for Chronic Pain
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,281 Total Patients Enrolled
25 Trials studying Chronic Pain
22,683 Patients Enrolled for Chronic Pain
University of South FloridaLead Sponsor
415 Previous Clinical Trials
188,764 Total Patients Enrolled
1 Trials studying Chronic Pain
~110 spots leftby Jan 2028
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