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Behavioral Intervention

Experimental for Chronic Insomnia

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

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

CBT-I

2018

Completed Phase 2

~620

Treatment as usual

2010

N/A

~6760

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,619,566 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,685 Total Patients Enrolled

University of South FloridaLead Sponsor

412 Previous Clinical Trials

186,894 Total Patients Enrolled

Frequently Asked Questions

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

Are researchers currently seeking participants for enrollment in this clinical trial?

"Affirmative. As per details on clinicaltrials.gov, this trial is presently enrolling participants. Initially shared on April 1st, 2024, the latest update was made on March 28th, 2024. The aim is to recruit 165 individuals at a single site for this study."

Answered by AI

What are the main goals being pursued in this research endeavor?

"The primary goal of this research endeavor, spanning from the initial dose administration to various follow-up time points such as after 8 weeks and a gradual withdrawal period, aims to evaluate alterations in Pain Intensity recorded through Daily Electronic Sleep Diaries. Additional secondary objectives involve assessing changes in Objective Sleep Onset Latency measured via Actigraph technology (specifically GENEActiv), monitoring shifts in Objective Sleep Efficiency also documented by Actigraph devices like GENEActiv, and analyzing modifications in Neural Connectivity using advanced imaging techniques including Structural/Functional MRI and Diffusion Weighted Imaging for an intricate evaluation of brain connectivity patterns."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

2024. "Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06345872.

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