Chronic PainNCT05226026
NiteCAPP_HELPS_WD: Improving Sleep and Reducing Opioid Use in Chronic Pain Patients
A study testing NiteCAPP HELPS and Tapered Withdrawal in people with Chronic Pain and Chronic Insomnia, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Chronic Insomnia, Opioid Use
- What is being tested?
- NiteCAPP HELPS and Tapered Withdrawal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2022to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Columbia
Columbia, Missouri, 65201
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain, Chronic Insomnia, Opioid Use
- Being tested
- NiteCAPP HELPS, Tapered Withdrawal
- Keywords
- Tapered withdrawal, NiteCAPP
- Medical subject headings
- Chronic Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiteCAPP HELPSBehavioural
4 weeks of NiteCAPP (a digital version of CBT-I recently developed at Mizzou)
Tapered WithdrawalOther
Gradual tapered withdrawal following CDC guidelines, with additional check-ins and motivational interviewing with a therapist.
| Study group | Role | What they receive |
|---|---|---|
| NiteCAPP HELPS | Experimental | 4 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins. Receives: Behavioral: NiteCAPP HELPS; Other: Tapered Withdrawal |
| Treatment as Usual | Other | Continuation of standard treatment for sleep and pain for 4 weeks, followed by tapered withdrawal and motivational interviewing and check-ins. Receives: Other: Tapered Withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index
Insomnia severity; score range 0-28 (low severity - high severity)
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Pain Intensity - Daily Electronic Sleep Diaries
Daily electronic dairies will record pain unpleasantness; range: 0-100 (none- most unpleasantness)
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries
Daily electronic dairies will record wake after sleep onset (number of minutes)
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Sleep Onset Latency- Daily Electronic Sleep Diaries
Daily electronic dairies will record sleep onset latency (number of minutes)
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Sleep Efficiency- Daily Electronic Sleep Diaries
Daily electronic dairies will record sleep efficiency
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Fatigue - Daily Electronic Sleep Diaries
Daily electronic dairies will record insomnia severity; range: 0-100 (no insomnia - most severe)
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries
Daily electronic dairies will record daily medication consumption
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Perceived Stress Scale
Perception of stress; score range: 0-40 (low stress - high stress)
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Peripheral Arousal
Heart Rate Variability (as measured by Holter-Monitoring)
Measured: 5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Pain Catastrophizing Scale
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.
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging
assessment of neural plasticity
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Thermal Pain Response
Participants will undergo quantitative sensory testing using a contact thermode applied to the left plantar, VAS scale for pain ()-100)
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Opioid Use (Quantitative)
Change in opioid use assessed with quantitative urine opioid panel
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Opioid Use (Self-Report)
Change in opioid use assessed with daily electronic diaries
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Secondary outcomes (8)
Change in State-Trait Anxiety Inventory (STAI)
Trait and state anxiety; score range: 20-80 (low anxiety - high anxiety)
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Depression (Beck Depression Inventory-II)
Depression severity; score range: 0-63 (normal - extreme depression)
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in 36-Item Short Form Survey (SF-36)
Self-reported health; score range: low quality of life to high quality of life
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Objective Wake After Sleep Onset (Actigraph)
Wake after sleep onset via Actiwatch-2
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Objective Sleep Onset Latency (Actigraph)
Sleep Onset Latency via Actiwatch-2
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Objective Sleep Efficiently (Actigraph)
Sleep Efficiency via Actiwatch-2
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in NIH Toolbox
20 minute computerized cognitive tasks
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in non-opioid substance use
self reported changes in non-opioid substances via electronic diaries
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start31 Mar 2022
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Why it stopped: NIDA R01 Awarded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina McCrae, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226026
- Sponsor's protocol ID
- 2053802
- Status last verified
- Aug 2024
- First submitted
- 8 Nov 2021
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain on Central Pain Processing
- ClinicalTrials.gov ID
- NCT05226026
- Acronym / sponsor ID
- 2053802
- Conditions
- Chronic Pain, Chronic Insomnia, Opioid Use
- Keywords
- Tapered withdrawal, NiteCAPP
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: NIDA R01 Awarded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NiteCAPP HELPS | Experimental | Behavioral: NiteCAPP HELPS, Other: Tapered Withdrawal4 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins. |
| Treatment as Usual | Other | Other: Tapered WithdrawalContinuation of standard treatment for sleep and pain for 4 weeks, followed by tapered withdrawal and motivational interviewing and check-ins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiteCAPP HELPS4 weeks of NiteCAPP (a digital version of CBT-I recently developed at Mizzou) | Behavioural | NiteCAPP HELPS |
| Tapered WithdrawalGradual tapered withdrawal following CDC guidelines, with additional check-ins and motivational interviewing with a therapist. | Other | NiteCAPP HELPS, Treatment as Usual |
Primary outcome
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)
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)
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)
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)
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
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)
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
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)
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)
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.
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
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)
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
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
8 secondary outcomes
Change in State-Trait Anxiety Inventory (STAI)
Time frame: 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
Change in 36-Item Short Form Survey (SF-36)
Time frame: 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
Change in Objective Sleep Onset Latency (Actigraph)
Time frame: 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
Change in NIH Toolbox
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NiteCAPP HELPS and Tapered Withdrawal in people with Chronic Pain and Chronic Insomnia, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index (time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.