Back to search results

Improving Sleep and Reducing Opioid Use for Chronic Pain

This study is looking for people with chronic widespread pain and chronic insomnia (trouble sleeping) who are also taking opioid medication. It aims to see if two different behavioral treatments can help improve sleep and reduce opioid use. One treatment is called CBT-I (Cognitive Behavioral Therapy for Insomnia), and the other is a standard treatment, both given in weekly online sessions. All participants will also receive support for gradually reducing their opioid medication. The study will measure changes in your insomnia, pain intensity, and how much you wake up after falling asleep, over several months. We are looking to enroll 165 participants, but the current status of the study is unclear.

Study design
This interventional study plans to enroll 165 participants who will be randomly assigned to receive either CBT-I or a standard behavioral treatment.
What's involved
You would complete 8 weekly online sessions, each lasting less than 45 minutes, followed by 2 bi-monthly booster sessions. You would also receive support for gradually reducing your opioid medication.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be monitored at baseline, 8 weeks, after completing opioid withdrawal, and at a 6-month follow-up.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06345872

Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

Recruiting
NAAges 18+InterventionalTreatment
University of South Florida
~165 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:CBT-ITreatment as usualTapered Withdrawal

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Insomnia Severity Index
Measured over Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
+12 more outcomes measured

Conditions

Chronic Pain
Chronic Insomnia
Opioid Use

Explore related trials

Chronic InsomniaChronic Pain

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Christina S McCrae, PhD · PRINCIPAL_INVESTIGATOR · University of South Florida
  • Britani Holland, PhD · STUDY_DIRECTOR · University of South Florida

Who to contact

Christina S McCrae, PhD
[email protected]
8139741804
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Insomnia Severity IndexSingle 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 DiariesSingle 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 DiariesSingle 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 DiariesSingle 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 DiariesSingle 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 DiariesSingle 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 DiariesSingle 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 ScaleSingle 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 Arousal5 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 ImagingSingle administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Assessment of neural plasticity

  • Change in Thermal Pain ResponseSingle 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)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)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