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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DA048972 | U.S. NIH Grant/Contract | View source |
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Study was halted due to inability to recruit the planned sample size within the funding period and study timeline.
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Adherence to prescription opioid and opioid tapering as indicated are critical for safe chronic opioid therapy for chronic pain, but this can be difficult for patients experiencing prescription opioid craving. Because pain catastrophizing is proposed as a possible treatment target by our and others' preliminary results, the proposed study aims to determine whether pain catastrophizing is a treatment target to reduce prescription opioid craving and to investigate whether negative affect and stress hormones are potential mediators. The findings from the current study will inform whether a psychology intervention to lower pain catastrophizing will reduce opioid craving, and whether psychological and physical distress as well as cognitive function will be potential mediators of the treatment effect.
Chronic pain and opioid overdose are two critical public health problems in the US. About 25 million adults (11%) suffer from chronic daily pain and up to 8 million use opioids to manage chronic pain. Unfortunately, 46 people die daily from overdose of prescription opioids. For safe chronic opioid therapy for chronic pain, physicians monitor patients' adherence to prescription opioids, and reduce or discontinue the prescription as indicated. Yet, adherence and cessation are not easy for some patients and one reason is opioid craving, a strong desire or urge to use opioids. Our preliminary data show about 34% of patients on chronic opioid therapy report craving. Craving is strongly associated with opioid misuse and negative health outcomes. To date, we do not fully understand the underlying mechanisms of prescription opioid craving in chronic pain sufferers, and psychological treatment targets to reduce craving. Based on our pilot survey, patients endorsing craving reported greater pain catastrophizing than those endorsing no craving. Our other survey study also reported a positive link between pain catastrophizing and opioid craving in patients on chronic opioid therapy for chronic pain conditions. Although these findings propose a possibility that lowering pain catastrophizing may decrease opioid craving, cross-sectional observational studies are limited in investigating a causal association. Potentially, pain catastrophizing enhances stress-induced opioid craving because stress-induced opioid craving is a well-established phenomenon in studies of addiction, and pain catastrophizing is associated with greater pain and emotional distress in patients with chronic pain. Therefore, the proposed project seeks to determine: a) the effect of pain catastrophizing on prescription opioid craving in patients on chronic opioid therapy for chronic pain and b) psychological (negative affect) and physiological (cortisol, norepinephrine) distress and cognitive function as potential mediating variables. The proposed study will use the previously validated protocol to temporarily induce and reduce pain catastrophizing and assess changes in opioid craving, negative affect, and stress hormones before and after pain catastrophizing manipulation. Additionally, this proposed study prospectively administers the protocol to reduce pain catastrophizing by thinking about and rehearsing a coping statement daily for 7 days and monitor daily opioid craving, opioid use and misuse, and negative affect for 14 days. The current project is expected to characterize the role of pain catastrophizing in opioid craving and opioid misuse, and pain catastrophizing as a critical psychological treatment target for reducing prescription opioid craving and improving prescription adherence. Furthermore, the protocol to manipulate pain catastrophizing can facilitate future research to study causal mechanisms involved in pain catastrophizing and the protocol to rapidly stabilize pain catastrophizing can be used clinically to improve the health outcome of patients taking prescription opioid for chronic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coping statement | Experimental | Daily practice of pain coping statements for 7 days |
|
| Control | No Intervention | No instruction about pain coping statement. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coping Statement | Behavioral | Daily practice of coping statement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Craving | Craving was assessed using a 0-100 Visual Analogue Scale (VAS), with higher scores indicating greater craving in the past 24 hours. | At day 7 (after intervention) |
| Craving | Craving was assessed using a 0-100 Visual Analogue Scale (VAS), with higher scores indicating greater craving in the past 24 hours. | At day 14 (7 days after intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Cortisol | Salivary cortisol level was the mean of samples collected at wake-up, 30 minutes after waking, and at 9:00 PM. Higher scores indicate higher cortisol levels. | At day 7 (after intervention) |
| Cortisol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dokyoung S You, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Pain Relief Innovations Lab | Palo Alto | California | 27604 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Coping Statement | Daily practice of pain coping statements for 7 days Coping Statement: Daily practice of coping statement |
| FG001 | Control | No instruction about pain coping statement. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Coping Statement | Daily practice of pain coping statements for 7 days Coping Statement: Daily practice of coping statement |
| BG001 | Control | No instruction about pain coping statement. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Craving | Craving was assessed using a 0-100 Visual Analogue Scale (VAS), with higher scores indicating greater craving in the past 24 hours. | Posted | Mean | Standard Deviation | score on a scale | At day 7 (after intervention) |
|
|
14 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Coping Statement | Daily practice of pain coping statements for 7 days Coping Statement: Daily practice of coping statement |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal thought without intent | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Includes colds/flus/throat pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dokyoung Sophia You, PhD | University of Oklahoma | 9186603923 | dokyoung-you@ou.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2024 | Nov 19, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 21, 2024 | May 20, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Salivary cortisol level was the mean of samples collected at wake-up, 30 minutes after waking, and at 9:00 PM. Possible scores range 0.012-3.000 ug/dL. Higher scores indicate higher cortisol levels.
| At day 14 (7 days after intervention) |
| Anxiety Symptoms | The Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 8-item short form was administered. 50 indicates the population mean with a standard deviation of 10. Possible T-Scores range from 20 - 80 and Higher scores indicate greater anxiety symptoms. | At day 7 (after intervention) |
| Anxiety Symptoms | The Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 8-item short form was administered. 50 indicates the population mean with a standard deviation of 10. Possible T-Scores range from 20 - 80. Higher scores indicate greater anxiety symptoms. | At day 14 (7 days after intervention) |
| Depression Symptoms | The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 8-item short form was administered. 50 indicates the population mean with a standard deviation of 10. Possible T-Scores range from 20 - 80. Higher scores indicate greater depression symptoms. | At day 7 (after intervention) |
| Depression Symptoms | The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 8-item short form was administered. 50 indicates the population mean with a standard deviation of 10. Possible T-Scores range from 20 - 80. Higher scores indicate greater depression symptoms. | At day 14 (7 days after intervention) |
| Prescription Opioid Misuse | The Current Opioid Misuse Measure (COMM), a 17-item questionnaire, was administered. Scores represent the total summed score and range from 0 to 68, with higher scores indicating greater opioid misuse | At day 14 (7 days after intervention) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Opioid Craving | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
|
| Primary | Craving | Craving was assessed using a 0-100 Visual Analogue Scale (VAS), with higher scores indicating greater craving in the past 24 hours. | Posted | Mean | Standard Deviation | score on a scale | At day 14 (7 days after intervention) |
|
|
|
|
| Secondary | Cortisol | Salivary cortisol level was the mean of samples collected at wake-up, 30 minutes after waking, and at 9:00 PM. Higher scores indicate higher cortisol levels. | Posted | Mean | Standard Deviation | ug/dL | At day 7 (after intervention) |
|
|
|
|
| Secondary | Cortisol | Salivary cortisol level was the mean of samples collected at wake-up, 30 minutes after waking, and at 9:00 PM. Possible scores range 0.012-3.000 ug/dL. Higher scores indicate higher cortisol levels. | Posted | Mean | Standard Deviation | ug/dL | At day 14 (7 days after intervention) |
|
|
|
|
| Secondary | Anxiety Symptoms | The Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 8-item short form was administered. 50 indicates the population mean with a standard deviation of 10. Possible T-Scores range from 20 - 80 and Higher scores indicate greater anxiety symptoms. | Posted | Mean | Standard Deviation | T-score | At day 7 (after intervention) |
|
|
|
|
| Secondary | Anxiety Symptoms | The Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 8-item short form was administered. 50 indicates the population mean with a standard deviation of 10. Possible T-Scores range from 20 - 80. Higher scores indicate greater anxiety symptoms. | Posted | Mean | Standard Deviation | T-score | At day 14 (7 days after intervention) |
|
|
|
|
| Secondary | Depression Symptoms | The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 8-item short form was administered. 50 indicates the population mean with a standard deviation of 10. Possible T-Scores range from 20 - 80. Higher scores indicate greater depression symptoms. | Posted | Mean | Standard Deviation | T-score | At day 7 (after intervention) |
|
|
|
|
| Secondary | Depression Symptoms | The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 8-item short form was administered. 50 indicates the population mean with a standard deviation of 10. Possible T-Scores range from 20 - 80. Higher scores indicate greater depression symptoms. | Posted | Mean | Standard Deviation | score on a scale | At day 14 (7 days after intervention) |
|
|
|
|
| Secondary | Prescription Opioid Misuse | The Current Opioid Misuse Measure (COMM), a 17-item questionnaire, was administered. Scores represent the total summed score and range from 0 to 68, with higher scores indicating greater opioid misuse | Posted | Mean | Standard Deviation | total score on a scale | At day 14 (7 days after intervention) |
|
|
|
|
| 0 |
| 44 |
| 1 |
| 44 |
| 7 |
| 44 |
| EG001 | Control | No instruction about pain coping statement. | 0 | 49 | 0 | 49 | 13 | 49 |
|
| Bladder Infection | Renal and urinary disorders | Systematic Assessment |
|
| Pain Flare-up | Musculoskeletal and connective tissue disorders | Systematic Assessment | Includes swelling and numbness |
|
| Bodily injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment | Back surgery |
|
| Financial hardship | Social circumstances | Systematic Assessment |
|
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