Stopped: NIDA R01 Awarded
This project addresses the highly significant problem of developing effective strategies for facilitating withdrawal from opioid medications. The proposed work is conceptualized within the context of a well-known theoretical framework (Cognitive Activation Theory of Stress), and the research questions are theory-driven. The team proposes to evaluate an innovative web-based version of CBT-I followed by tapered withdrawal in a randomized trial in comparison to a Treatment As Usual control followed by tapered withdrawal. The dependent measures have been well-selected to effectively evaluate the outcomes. The methodological details are rigorous.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change in Insomnia Severity Index
Timeframe: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Pain Intensity - Daily Electronic Sleep Diaries
Timeframe: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries
Timeframe: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Sleep Onset Latency- Daily Electronic Sleep Diaries
Timeframe: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Sleep Efficiency- Daily Electronic Sleep Diaries
Timeframe: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Fatigue - Daily Electronic Sleep Diaries
Timeframe: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries
Timeframe: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Perceived Stress Scale
Timeframe: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Peripheral Arousal
Timeframe: 5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Pain Catastrophizing Scale
Timeframe: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging
Timeframe: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Thermal Pain Response
Timeframe: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Opioid Use (Quantitative)
Timeframe: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Opioid Use (Self-Report)
Timeframe: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal