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Behavioral Intervention
Web-Based Cognitive Behavioral Therapy for Opioid Withdrawal
N/A
Waitlist Available
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with chronic widespread pain and insomnia
18+ yrs old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal
Awards & highlights
Study Summary
This trial aims to develop a web-based version of Cognitive Behavioral Therapy to help people safely withdraw from opioid medications. It will be evaluated in a randomized trial to compare it to existing treatments.
Who is the study for?
Adults over 18 with chronic widespread pain and insomnia, who want to reduce or stop using opioid medication. They must be able to read English, have their doctor's consent, and have been on opioids for at least a month. Pregnant individuals, those with certain back conditions or recent surgery, metal implants/electrical devices in the body, severe mental health issues other than depression/anxiety, or untreated sleep disorders like severe sleep apnea are excluded.Check my eligibility
What is being tested?
The trial is testing an online version of Cognitive Behavioral Therapy for Insomnia (CBT-I) followed by a planned reduction in opioid use against usual treatment plus opioid reduction. Participants will be randomly assigned to one of these two approaches to see which is more effective at improving sleep and reducing reliance on opioids.See study design
What are the potential side effects?
Potential side effects may include discomfort from withdrawal symptoms such as restlessness, mood changes, and physical pain increases as participants taper off opioids. The CBT-I program itself has minimal risks but may initially lead to increased tiredness due to changes in sleeping patterns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with widespread pain and trouble sleeping.
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I am 18 years old or older.
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I have my doctor's written approval for opioid medication.
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I have been taking opioid medication regularly for over a month.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal
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
+11 moreSecondary outcome measures
Change in 36-Item Short Form Survey (SF-36)
Change in Depression (Beck Depression Inventory-II)
Change in NIH Toolbox
+5 moreOther outcome measures
Satisfaction Survey
Trial Design
2Treatment groups
Experimental Treatment
Group I: Treatment as UsualExperimental Treatment1 Intervention
Continuation of standard treatment for sleep and pain for 4 weeks, followed by tapered withdrawal and motivational interviewing and check-ins.
Group II: NiteCAPP HELPSExperimental Treatment2 Interventions
4 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins.
Find a Location
Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
361 Previous Clinical Trials
627,968 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a sleep disorder other than insomnia, like severe sleep apnea or frequent limb movements.I had back surgery less than 6 months ago.I have been diagnosed with widespread pain and trouble sleeping.I am 18 years old or older.I am not using any non-drug treatments for pain, sleep, or mood issues.I have a confirmed or suspected pinched nerve in my lower back.I want to reduce or stop using opioids.I have been diagnosed with narrowing of the spinal canal in my lower back.I have my doctor's written approval for opioid medication.I am not on medications that affect my pain or sleep, except those prescribed specifically for these issues.I have been taking opioid medication regularly for over a month.I am unable to understand and give consent for treatment.I have a spinal condition.You have difficulty with memory and thinking.I do not have bipolar or seizure disorders.You have severe mental health issues that are not being treated, except for depression or anxiety. This includes thoughts of suicide or serious mental disorders.I haven't taken sleep medication for over a month, or my use has been stable for more than 6 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: NiteCAPP HELPS
- Group 2: Treatment as Usual
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings in this research project?
"As indicated on clinicaltrials.gov, this medical investigation is not presently admitting patients. Initially posted on March 31st 2022, the trial was most recently updated on 8th of March 2023. Although it is no longer recruiting individuals, there are 697 other trials actively searching for participants at present."
Answered by AI
What outcomes is this empirical investigation aiming to produce?
"The principal aim of this medical trial, which will be tracked over an 8-week period with a Single administration at the beginning and end points, is to gauge Change in Sleep Onset Latency- Daily Electronic Sleep Diaries. Further objectives include assessing Change in Objective Sleep Onset Latency (Actigraph) via Actiwatch-2 measurements, evaluating Change in 36-Item Short Form Survey (SF-36), a self reported health assessment ranging from low quality of life to high quality of life, as well as measuring Change in NIH Toolbox through 20 minute computerized cognitive tasks."
Answered by AI
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