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

NCT05226026 | Withdrawn

• 1 other identifier: 2053802
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Chronic Pain; Chronic Insomnia; Opioid Use

Keywords

Tapered withdrawal; NiteCAPP

Outcome Measures

Primary Outcomes (14)

• Change in Insomnia Severity Index

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  assessment of neural plasticity

  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)

  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

  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

  Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal

Secondary Outcomes (8)

• Change in State-Trait Anxiety Inventory (STAI)

  Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal

• Change in Depression (Beck Depression Inventory-II)

  Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal

• Change in 36-Item Short Form Survey (SF-36)

  Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal

• Change in Objective Wake After Sleep Onset (Actigraph)

  Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal

• Change in Objective Sleep Onset Latency (Actigraph)

  Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal

Other Outcomes (1)

• Satisfaction Survey

  Single administration at post-treatment - 8 weeks, following completion of gradual tapered withdrawal

Study Arms (2)

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.

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.

Other: Tapered Withdrawal

Interventions

NiteCAPP HELPS BEHAVIORAL

4 weeks of NiteCAPP (a digital version of CBT-I recently developed at Mizzou)

NiteCAPP HELPS

Tapered Withdrawal OTHER

Gradual tapered withdrawal following CDC guidelines, with additional check-ins and motivational interviewing with a therapist.

NiteCAPP HELPS; Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65201, United States

Location

MeSH Terms

Conditions

Chronic Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director MizZzou Sleep Research Lab

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: February 7, 2022
• Study Start: March 31, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)