NiteCAPP_HELPS_WD: Improving Sleep and Reducing Opioid Use in Chronic Pain Patients
WithdrawnNot applicableNCT05226026
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Impact of Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain on Central Pain Processing
- Conditions
- Interventions
- Behavioral: NiteCAPP HELPS
- Other: Tapered Withdrawal
- Sponsor
- University of Missouri-Columbia
- Start date
- 2022-03-31
- Primary completion
- 2024-06-01
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05226026