Recruiting

Observational Study

Sponsor:

University of South Florida

Code:

NCT06345872

Conditions

Chronic Pain

Chronic Insomnia

Opioid Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

CBT-I

Treatment as usual

Tapered Withdrawal

Study Details

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

Study ID

NCT06345872

Start date

Dec 11, 2024

Status verified date

Apr, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

165 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental

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

other: Treatment as usual

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

Interventions

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.

Tapered Withdrawal

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

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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Change in Perceived Stress Scale [ Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up ]
  • 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 ]
  • 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 ]
  • Change in Thermal Pain Response [ Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up ]
  • 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 (Self-Report) [ Time Frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up ]

Central Contacts and Locations

Central contacts

Christina S McCrae, PhD

8139741804christinamccrae@usf.edu

Britani Holland, PhD

8139741804blalone@usf.edu

Locations

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

Christina S McCrae, PhD

813-974-1804christinamccrae@usf.edu

Britani Holland, PhD

8139741804blalone@usf.edu

More Information

Sponsor

University of South Florida

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2026-04-21.