What this study is
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.
What's being tested
- CBT-I
Intervention · 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.
- Treatment as usual
Intervention · 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.
- Tapered Withdrawal
Intervention · OTHER
Individualized gradual tapered withdrawal following CDC guidelines, additional check-ins and motivational interviewing with a therapist.
Study details
- Official title
- SPIN Opioid: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain
- Sponsor
- University of South Florida
- Conditions
- Chronic Pain · Chronic Insomnia · Opioid Use
- Enrolling
- 165 people
- Starts
- 2024-12-11
- Est. completion
- 2028-07
- Design
- Triple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of South Florida
Tampa, Florida, United States
- Christina S McCrae, PhD · Contact813-974-1804christinamccrae@usf.edu
- Britani Holland, PhD · Contact8139741804blalone@usf.edu
Recruiting
Study team
Sponsor
University of South Florida
Study ID STUDY005883
Principal investigator
Christina S McCrae, PhD
University of South Florida
Study director
Britani Holland, PhD
University of South Florida
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.