University of South Florida
Tampa, Florida, 33612, United States
Location status: Recruiting
Location contact
Britani Holland, PhD
CONTACT
Christina S McCrae, PhD
CONTACT
NCT Number: NCT06345872
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Tampa, Florida, 33612, United States
Location status: Recruiting
Britani Holland, PhD
CONTACT
Christina S McCrae, PhD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Individualized gradual tapered withdrawal following CDC guidelines, additional check-ins and motivational interviewing with a therapist.
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)
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)
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)
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)
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
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)
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)
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)
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)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Assessment of neural plasticity
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)
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
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
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Wake after sleep onset via GENEActiv
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Sleep Onset Latency via GENEActiv
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Sleep Efficiency via GENEActiv
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Assessment of brain connectivity
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Modified from validated alcohol survey for opioid related problems
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
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.
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Self-reported health; score range: low quality of life to high quality of life
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Depression severity; score range: 0-63 (normal - extreme depression)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Trait and state anxiety; score range: 20-80 (low anxiety - high anxiety)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Non-opioid pain/sleep medication use and dosage, tobacco, caffeine, alcohol, marijuana via daily electronic diaries
Time frame: Single administration at 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Monitor changes in withdrawal symptoms
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Monitor of cravings related to opioid use
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
20-minute of two computerized cognitive tasks
Contact information is provided by the study sponsor or research team.
Britani Holland, PhD
CONTACT
Christina S McCrae, PhD
CONTACT
University of South Florida
Other
SPIN Opioid: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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