Chronic PainNCT06345872
Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain
A study testing CBT-I, Treatment as usual and Tapered Withdrawal in people with Chronic Pain and Chronic Insomnia, run by University of South Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Chronic Insomnia, Opioid Use
- What is being tested?
- CBT-I, Treatment as usual and Tapered Withdrawal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2024to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of South Florida
Tampa, Florida, 33612
Christina S McCrae, PhD, 813-974-1804, christinamccrae@usf.edu
Britani Holland, PhD, 8139741804, blalone@usf.edu
About this study
Official title: SPIN Opioid: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain
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.
Read the detailed 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.
- Conditions
- Chronic Pain, Chronic Insomnia, Opioid Use
- Being tested
- CBT-I, Treatment as usual, Tapered Withdrawal
- Keywords
- Chronic pain, Chronic insomnia, Opioid use, CBT-I
- Medical subject headings
- Chronic Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-IBehavioural
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 usualBehavioural
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 WithdrawalOther
Individualized gradual tapered withdrawal following CDC guidelines, additional check-ins and motivational interviewing with a therapist.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 8 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins. Receives: 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. Receives: Behavioral: Treatment as usual; Other: Tapered Withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index
Insomnia severity; score range 0-28 (low severity - high severity)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Wake after sleep onset via GENEActiv
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in Objective Sleep Onset Latency (Actigraph)
Sleep Onset Latency via GENEActiv
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in Objective Sleep Efficiency (Actigraph)
Sleep Efficiency via GENEActiv
Measured: 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
Assessment of brain connectivity
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Short Inventory of Problems
Modified from validated alcohol survey for opioid related problems
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
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.
Measured: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start11 Dec 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Christina S McCrae, PhD, Principal investigator, University of South FloridaBritani Holland, PhD, Study director, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345872
- Sponsor's protocol ID
- STUDY005883
- Other IDs
- 1R01DA054311
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30496533McCrae 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.
PubMed 32126156Morin 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.
PubMed 16459140McCrae 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.
PubMed 30176973Seal 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.
PubMed 22396516Martinez 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.
PubMed 23744045
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPIN Opioid: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain
- ClinicalTrials.gov ID
- NCT06345872
- Acronym / sponsor ID
- STUDY005883
- Conditions
- Chronic Pain, Chronic Insomnia, Opioid Use
- Keywords
- Chronic pain, Chronic insomnia, Opioid use, CBT-I
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: CBT-I, Other: Tapered Withdrawal8 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins. |
| Treatment as usual | Other | Behavioral: Treatment as usual, Other: Tapered WithdrawalContinuation of standard treatment for sleep and pain for 8 weeks, followed by tapered withdrawal and motivational interviewing and check-ins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-IIncludes 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. | Behavioural | Experimental |
| Treatment as usualIncludes 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. | Behavioural | Treatment as usual |
| Tapered WithdrawalIndividualized gradual tapered withdrawal following CDC guidelines, additional check-ins and motivational interviewing with a therapist. | Other | Experimental, Treatment as usual |
Primary outcome
Change in Insomnia Severity Index
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Insomnia severity; score range 0-28 (low severity - high severity)
Change in Pain Intensity - Daily Electronic Sleep Diaries
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Daily electronic dairies will record pain unpleasantness; range: 0-100 (none- most unpleasantness)
Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Daily electronic dairies will record wake after sleep onset (number of minutes)
Change in Sleep Onset Latency- Daily Electronic Sleep Diaries
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Daily electronic dairies will record sleep onset latency (number of minutes)
Change in Sleep Efficiency- Daily Electronic Sleep Diaries
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Daily electronic dairies will record sleep efficiency
Change in Fatigue - Daily Electronic Sleep Diaries
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Daily electronic dairies will record insomnia severity; range: 0-100 (no insomnia - most severe)
Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Daily electronic dairies will record daily medication consumption)
Change in Perceived Stress Scale
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Perception of stress; score range: 0-40 (low stress - high stress)
Change in Peripheral Arousal
Time frame: 5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Heart Rate Variability (as measured by Holter-Monitoring)
Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Assessment of neural plasticity
Change in Thermal Pain Response
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Participants will undergo quantitative sensory testing using a contact thermode applied to the left plantar, VAS scale for pain ()-100)
Change in Opioid Use (Quantitative)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in opioid use assessed with quantitative urine opioid panel
Change in Opioid Use (Self-Report)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in opioid use assessed with daily electronic diaries
6 secondary outcomes
Change in Objective Wake After Sleep Onset (Actigraph)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in Objective Sleep Onset Latency (Actigraph)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in Objective Sleep Efficiency (Actigraph)
Time frame: 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
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Short Inventory of Problems
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in Pain Catastrophizing Scale
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 30496533McCrae 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.
- Background: PubMed 32126156McCrae 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.
- Background: PubMed 16459140Morin 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.
- Background: PubMed 30176973McCrae 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.
- Background: PubMed 22396516Seal 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.
- Background: PubMed 23744045Martinez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina S McCrae, PhD principal investigator
University of South Florida
Britani Holland, PhD study director
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-I, Treatment as usual and Tapered Withdrawal in people with Chronic Pain and Chronic Insomnia, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina S McCrae, PhD (8139741804, christinamccrae@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index (time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06345872, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.