Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

NCT06345872 | Recruiting DMC

• 2 other identifiers: STUDY0058831R01DA054311
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to test two behavioral interventions for chronic insomnia in individuals with chronic pain and use prescribed opioid medication to treat their chronic pain.

Conditions

Chronic Pain; Chronic Insomnia; Opioid Use

Keywords

Chronic pain; Chronic insomnia; Opioid use; CBT-I

Outcome Measures

Primary Outcomes (13)

• 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, and 6 month follow-up

• 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, and 6 month follow-up

• 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, and 6 month follow-up

• 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, and 6 month follow-up

• 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, and 6 month follow-up

• 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, and 6 month follow-up

• 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, and 6 month follow-up

• 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, and 6 month follow-up

• 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, and 6 month follow-up

• 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, and 6 month follow-up

• 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, and 6 month follow-up

• 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, and 6 month follow-up

• 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, and 6 month follow-up

Secondary Outcomes (6)

• Change in Objective Wake After Sleep Onset (Actigraph)

  Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

• Change in Objective Sleep Onset Latency (Actigraph)

  Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

• Change in Objective Sleep Efficiency (Actigraph)

  Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

• Change in Neural Connectivity: Structural/Functional MRI/Diffusion Weighted Imaging

  Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

• Short Inventory of Problems

  Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

Other Outcomes (7)

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

  Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

• Change in Depression (Beck Depression Inventory-II)

  Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

• Change in State-Trait Anxiety Inventory (STAI)

  Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

Study Arms (2)

Experimental

EXPERIMENTAL

8 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins.

Behavioral: CBT-I; Other: Tapered Withdrawal

Treatment as usual

OTHER

Continuation of standard treatment for sleep and pain for 8 weeks, followed by tapered withdrawal and motivational interviewing and check-ins.

Behavioral: Treatment as usual; Other: Tapered Withdrawal

Interventions

CBT-I BEHAVIORAL

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.

Experimental

Treatment as usual BEHAVIORAL

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.

Treatment as usual

Tapered Withdrawal OTHER

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

Experimental; 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
• 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

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 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

Sponsors & Collaborators

• University of South Florida: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 30496533 BACKGROUND

• 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.

  PMID: 32126156 BACKGROUND

• 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.

  PMID: 16459140 BACKGROUND

• 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.

  PMID: 30176973 BACKGROUND

• 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.

  PMID: 22396516 BACKGROUND

• 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.

  PMID: 23744045 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Sleep Initiation and Maintenance Disorders

Interventions

Therapeutics

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 Officials

• Christina S McCrae, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

• Britani Holland, PhD

  University of South Florida

  STUDY DIRECTOR

Central Study Contacts

Christina S McCrae, PhD

CONTACT

8139741804; christinamccrae@usf.edu

Britani Holland, PhD

CONTACT

8139741804; blalone@usf.edu

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: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: December 11, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)