NiteCAPP_HELPS_WD: Improving Sleep and Reducing Opioid Use in Chronic Pain Patients

August 1, 2024 updated by: Christina McCrae, University of Missouri-Columbia

Impact of Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain on Central Pain Processing

This project addresses the highly significant problem of developing effective strategies for facilitating withdrawal from opioid medications. The proposed work is conceptualized within the context of a well-known theoretical framework (Cognitive Activation Theory of Stress), and the research questions are theory-driven. The team proposes to evaluate an innovative web-based version of CBT-I followed by tapered withdrawal in a randomized trial in comparison to a Treatment As Usual control followed by tapered withdrawal. The dependent measures have been well-selected to effectively evaluate the outcomes. The methodological details are rigorous.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Individuals with chronic widespread pain are often prescribed opioid therapy. Unfortunately, opioid therapy offers questionable benefit for long-term pain management and is associated with other negative outcomes (arrhythmias, overdose, death). Individuals with chronic pain experience high rates of comorbid chronic insomnia, increased cognitive and physiological arousal, and disrupted executive function. They also often develop abnormal brain activation at rest and in response to painful stimuli (aka central sensitization). The investigator's research and other research shows individuals with chronic pain exhibit increased brain activation in the default mode network at rest and in regions associated with pain modulation in response to painful stimuli compared to healthy controls. Withdrawal from opioids can be difficult; and inadequately managed pain, abnormal brain activation, disrupted executive function, increased arousal, and poor sleep contribute to that difficulty. Consistent with the Cognitive Activation Theory of Stress (CATS), The investigators hypothesize that poor sleep and sustained arousal lead to critical changes in brain activation and disrupted executive function that increase pain and lead to opioid use. The proposed pilot will randomize 26 prescription opioid users who have chronic widespread pain and insomnia to 4 weeks of NiteCAPP (a digital version of CBT-I recently developed at Mizzou) or treatment as usual. They will then complete a gradual tapered withdrawal protocol for opioids.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65201
        • University of Missouri-Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18+ yrs old
  • willing to be randomized
  • can read/understand English
  • diagnosed with chronic widespread pain and insomnia
  • prescribed opioid medication for 1+ mo, 3+ times per week
  • desire to reduce or eliminate opioid use
  • written agreement from physician prescribing opioid medication
  • no prescribed or OTC sleep meds for 1+ mo, or stabilized for 6+ wks.

Exclusion Criteria:

  • unable to provide informed consent
  • cognitive impairment (MMSE <26)
  • sleep disorder other than insomnia [i.e., sleep apnea (apnea/hypopnea index, AHI >15), Periodic Limb Movement Disorder (myoclonus arousals per hour >15)]
  • bipolar or seizure disorder (due to risk of sleep restriction treatment)
  • other severe, untreated major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders)
  • psychotropic or other medications (e.g., beta-blockers) that alter pain or sleep (medications prescribed for pain or sleep are allowed)
  • participation in other non-pharmacological treatment for pain, sleep, or mood outside current Internal metal objects or electrical devices
  • pregnancy
  • presumptive/confirmed lumbar nerve root compression
  • confirmed lumbar spinal stenosis
  • <6 mos post back surgery
  • other spinal disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NiteCAPP HELPS
4 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins.
Behavioral: NiteCAPP HELPS
4 weeks of NiteCAPP (a digital version of CBT-I recently developed at Mizzou)
Other: Tapered Withdrawal
Gradual tapered withdrawal following CDC guidelines, with additional check-ins and motivational interviewing with a therapist.
Other: Treatment as Usual
Continuation of standard treatment for sleep and pain for 4 weeks, followed by tapered withdrawal and motivational interviewing and check-ins.
Other: Tapered Withdrawal
Gradual tapered withdrawal following CDC guidelines, with additional check-ins and motivational interviewing with a therapist.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Insomnia Severity Index
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Insomnia severity; score range 0-28 (low severity - high severity)
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Pain Intensity - Daily Electronic Sleep Diaries
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Daily electronic dairies will record pain unpleasantness; range: 0-100 (none- most unpleasantness)
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Daily electronic dairies will record wake after sleep onset (number of minutes)
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Sleep Onset Latency- Daily Electronic Sleep Diaries
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Daily electronic dairies will record sleep onset latency (number of minutes)
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Sleep Efficiency- Daily Electronic Sleep Diaries
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Daily electronic dairies will record sleep efficiency
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Fatigue - Daily Electronic Sleep Diaries
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Daily electronic dairies will record insomnia severity; range: 0-100 (no insomnia - most severe)
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Daily electronic dairies will record daily medication consumption
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Perceived Stress Scale
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Perception of stress; score range: 0-40 (low stress - high stress)
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Peripheral Arousal
Time Frame: 5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal
Heart Rate Variability (as measured by Holter-Monitoring)
5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Pain Catastrophizing Scale
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness. Total score range from 0-52, with higher scores indicating greater pain catastrophizing.
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
assessment of neural plasticity
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Thermal Pain Response
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Participants will undergo quantitative sensory testing using a contact thermode applied to the left plantar, VAS scale for pain ()-100)
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Opioid Use (Quantitative)
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in opioid use assessed with quantitative urine opioid panel
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Opioid Use (Self-Report)
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in opioid use assessed with daily electronic diaries
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in State-Trait Anxiety Inventory (STAI)
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Trait and state anxiety; score range: 20-80 (low anxiety - high anxiety)
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Depression (Beck Depression Inventory-II)
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Depression severity; score range: 0-63 (normal - extreme depression)
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in 36-Item Short Form Survey (SF-36)
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Self-reported health; score range: low quality of life to high quality of life
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Objective Wake After Sleep Onset (Actigraph)
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Wake after sleep onset via Actiwatch-2
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Objective Sleep Onset Latency (Actigraph)
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Sleep Onset Latency via Actiwatch-2
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Objective Sleep Efficiently (Actigraph)
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Sleep Efficiency via Actiwatch-2
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in NIH Toolbox
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
20 minute computerized cognitive tasks
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in non-opioid substance use
Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
self reported changes in non-opioid substances via electronic diaries
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Satisfaction Survey
Time Frame: Single administration at post-treatment - 8 weeks, following completion of gradual tapered withdrawal
Experience with the assessments, procedures, and other features of the research study; score range: 9-90 (low satisfaction - high satisfaction)
Single administration at post-treatment - 8 weeks, following completion of gradual tapered withdrawal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Missouri-Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2053802

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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