Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain
NCT ID: NCT06345872
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
165 participants
INTERVENTIONAL
2024-12-11
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental
8 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins.
CBT-I
Includes 8 weekly sessions of CBT-I and 2 bi-monthly boosters. Each session is to be completed individually by the participant in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed.
Tapered Withdrawal
Individualized gradual tapered withdrawal following CDC guidelines, additional check-ins and motivational interviewing with a therapist.
Treatment as usual
Continuation of standard treatment for sleep and pain for 8 weeks, followed by tapered withdrawal and motivational interviewing and check-ins.
Treatment as usual
Includes 8 weekly sessions of standard treatment and 2 bi-monthly boosters. Each session is to be completed individually by the participant in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed.
Tapered Withdrawal
Individualized gradual tapered withdrawal following CDC guidelines, additional check-ins and motivational interviewing with a therapist.
Interventions
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Treatment as usual
Includes 8 weekly sessions of standard treatment and 2 bi-monthly boosters. Each session is to be completed individually by the participant in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed.
CBT-I
Includes 8 weekly sessions of CBT-I and 2 bi-monthly boosters. Each session is to be completed individually by the participant in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed.
Tapered Withdrawal
Individualized gradual tapered withdrawal following CDC guidelines, additional check-ins and motivational interviewing with a therapist.
Eligibility Criteria
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Inclusion Criteria
* willing to be randomized,
* can read/understand English
* diagnosed with chronic widespread pain and insomnia (as described below)
* 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 on meds for 6+ wks
Exclusion Criteria
* 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 for 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 the current trial
* 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
18 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute on Drug Abuse (NIDA)
NIH
University of South Florida
OTHER
Responsible Party
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Principal Investigators
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Christina S McCrae, PhD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Britani Holland, PhD
Role: STUDY_DIRECTOR
University of South Florida
Locations
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University of South Florida
Tampa, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Christina S McCrae, PhD
Role: primary
Britani Holland, PhD
Role: backup
References
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McCrae CS, Williams J, Roditi D, Anderson R, Mundt JM, Miller MB, Curtis AF, Waxenberg LB, Staud R, Berry RB, Robinson ME. Cognitive behavioral treatments for insomnia and pain in adults with comorbid chronic insomnia and fibromyalgia: clinical outcomes from the SPIN randomized controlled trial. Sleep. 2019 Mar 1;42(3):zsy234. doi: 10.1093/sleep/zsy234.
McCrae CS, Curtis AF, Miller MB, Nair N, Rathinakumar H, Davenport M, Berry JR, McGovney K, Staud R, Berry R, Robinson M. Effect of cognitive behavioural therapy on sleep and opioid medication use in adults with fibromyalgia and insomnia. J Sleep Res. 2020 Dec;29(6):e13020. doi: 10.1111/jsr.13020. Epub 2020 Mar 3.
Morin CM, LeBlanc M, Daley M, Gregoire JP, Merette C. Epidemiology of insomnia: prevalence, self-help treatments, consultations, and determinants of help-seeking behaviors. Sleep Med. 2006 Mar;7(2):123-30. doi: 10.1016/j.sleep.2005.08.008. Epub 2006 Feb 3.
McCrae CS, Mundt JM, Curtis AF, Craggs JG, O'Shea AM, Staud R, Berry RB, Perlstein WM, Robinson ME. Gray Matter Changes Following Cognitive Behavioral Therapy for Patients With Comorbid Fibromyalgia and Insomnia: A Pilot Study. J Clin Sleep Med. 2018 Sep 15;14(9):1595-1603. doi: 10.5664/jcsm.7344.
Seal KH, Shi Y, Cohen G, Cohen BE, Maguen S, Krebs EE, Neylan TC. Association of mental health disorders with prescription opioids and high-risk opioid use in US veterans of Iraq and Afghanistan. JAMA. 2012 Mar 7;307(9):940-7. doi: 10.1001/jama.2012.234.
Martinez MP, Miro E, Sanchez AI, Diaz-Piedra C, Caliz R, Vlaeyen JW, Buela-Casal G. Cognitive-behavioral therapy for insomnia and sleep hygiene in fibromyalgia: a randomized controlled trial. J Behav Med. 2014 Aug;37(4):683-97. doi: 10.1007/s10865-013-9520-y. Epub 2013 Jun 7.
Other Identifiers
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STUDY005883
Identifier Type: -
Identifier Source: org_study_id