Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

Chronic Pain Clinical Trial

Official title:

SPIN Opioid: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06345872
• Other study ID #: STUDY005883
• Secondary ID: 1R01DA054311
• Status: Recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: July 2028

Study information

• Verified date: April 2024
• Source: University of South Florida
• Contact: Christina S McCrae, PhD
• Phone: (813) 974-1804
• Email: christinamccrae[@]usf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Opioid therapy is commonly prescribed for patients with chronic widespread musculoskeletal pain, but offers questionable benefit for long-term pain management and is associated with arrhythmias, overdose, and death. Individuals with chronic pain experience high rates of comorbid chronic insomnia, arousal, and abnormal brain activation in response to painful stimuli. Research shows individuals with chronic pain exhibit increased brain activation in regions associated with pain modulation in response to painful stimuli compared to healthy controls. Withdrawal from opioids is difficult; and inadequately managed pain contributes to that difficulty. The Cognitive Activation Theory of Stress (CATS) tests the hypothesis that poor sleep and arousal lead to critical changes in brain activation that increase pain severity and lead to opioid use. Research shows cognitive behavioral treatment for insomnia (CBT-I, an evidence based intervention for chronic insomnia) improves sleep, arousal, abnormal brain activation, and pain in individuals with comorbid chronic pain and insomnia, but does not reduce opioid use. However, because CBT-I improves each of the mediators hypothesized to contribute to opioid use, it warrants examination as a neoadjuvant to gradual tapering of opioid medication. The proposed trial tests the novel hypothesis that improving sleep and decreasing arousal will lead to normalized brain activation and decreased pain prior to gradual tapering, which will facilitate reduced opioid use. This hypothesis is supported by theory (CATS) and empirical findings. It also reflects federal pain research priorities.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: July 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18+ 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

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 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

Related Conditions & MeSH terms

• Chronic Insomnia
• Chronic Pain
• Opioid Use
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• 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.
• 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.

Other:
• Tapered Withdrawal
Individualized gradual tapered withdrawal following CDC guidelines, additional check-ins and motivational interviewing with a therapist.

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of South Florida	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: JAMA. 2012 Jun 20;307(23):2489. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in 36-Item Short Form Survey (SF-36)	Self-reported health; score range: low quality of life to high quality of life	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Other	Change in Depression (Beck Depression Inventory-II)	Depression severity; score range: 0-63 (normal - extreme depression)	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Other	Change in State-Trait Anxiety Inventory (STAI)	Trait and state anxiety; score range: 20-80 (low anxiety - high anxiety)	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Other	Medications/Substances Uses and Dosages	Non-opioid pain/sleep medication use and dosage, tobacco, caffeine, alcohol, marijuana via daily electronic diaries	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Other	Change in Subjective Opioid Withdrawal Scale (SOWS)	Monitor changes in withdrawal symptoms	Single administration at 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Other	Change in Opioid Cravings Scale	Monitor of cravings related to opioid use	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Other	Change in NIH Toolbox	20-minute of two computerized cognitive tasks	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change in Objective Wake After Sleep Onset (Actigraph)	Wake after sleep onset via GENEActiv	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Secondary	Change in Objective Sleep Onset Latency (Actigraph)	Sleep Onset Latency via GENEActiv	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Secondary	Change in Objective Sleep Efficiency (Actigraph)	Sleep Efficiency via GENEActiv	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Secondary	Change in Neural Connectivity: Structural/Functional MRI/Diffusion Weighted Imaging	Assessment of brain connectivity	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Secondary	Short Inventory of Problems	Modified from validated alcohol survey for opioid related problems	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Secondary	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, and 6 month follow-up