Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Satisfaction Survey |
Experience with the assessments, procedures, and other features of the research study; score range: 9-90 (low satisfaction - high satisfaction) |
Single administration at post-treatment - 8 weeks, following completion of gradual tapered withdrawal |
|
Primary |
Change in Insomnia Severity Index |
Insomnia severity; score range 0-28 (low severity - high severity) |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Primary |
Change in Pain Intensity - Daily Electronic Sleep Diaries |
Daily electronic dairies will record pain unpleasantness; range: 0-100 (none- most unpleasantness) |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Primary |
Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries |
Daily electronic dairies will record wake after sleep onset (number of minutes) |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Primary |
Change in Sleep Onset Latency- Daily Electronic Sleep Diaries |
Daily electronic dairies will record sleep onset latency (number of minutes) |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Primary |
Change in Sleep Efficiency- Daily Electronic Sleep Diaries |
Daily electronic dairies will record sleep efficiency |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Primary |
Change in Fatigue - Daily Electronic Sleep Diaries |
Daily electronic dairies will record insomnia severity; range: 0-100 (no insomnia - most severe) |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Primary |
Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries |
Daily electronic dairies will record daily medication consumption |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Primary |
Change in Perceived Stress Scale |
Perception of stress; score range: 0-40 (low stress - high stress) |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Primary |
Change in Peripheral Arousal |
Heart Rate Variability (as measured by Holter-Monitoring) |
5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Primary |
Change in Pain Catastrophizing Scale |
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. |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Primary |
Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging |
assessment of neural plasticity |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Primary |
Change in Thermal Pain Response |
Participants will undergo quantitative sensory testing using a contact thermode applied to the left plantar, VAS scale for pain ()-100) |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Primary |
Change in Opioid Use (Quantitative) |
Change in opioid use assessed with quantitative urine opioid panel |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Primary |
Change in Opioid Use (Self-Report) |
Change in opioid use assessed with daily electronic diaries |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Secondary |
Change in State-Trait Anxiety Inventory (STAI) |
Trait and state anxiety; score range: 20-80 (low anxiety - high anxiety) |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Secondary |
Change in Depression (Beck Depression Inventory-II) |
Depression severity; score range: 0-63 (normal - extreme depression) |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Secondary |
Change in 36-Item Short Form Survey (SF-36) |
Self-reported health; score range: low quality of life to high quality of life |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Secondary |
Change in Objective Wake After Sleep Onset (Actigraph) |
Wake after sleep onset via Actiwatch-2 |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Secondary |
Change in Objective Sleep Onset Latency (Actigraph) |
Sleep Onset Latency via Actiwatch-2 |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Secondary |
Change in Objective Sleep Efficiently (Actigraph) |
Sleep Efficiency via Actiwatch-2 |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Secondary |
Change in NIH Toolbox |
20 minute computerized cognitive tasks |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|
Secondary |
Change in non-opioid substance use |
self reported changes in non-opioid substances via electronic diaries |
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal |
|