Chronic Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Daily practice of coping statement
Sponsors
Study design
Eligibility
Inclusion criteria
* At least 18 years * Chronic pain ( \> 3months) * Prescription opioid use (\>3 months)
Exclusion criteria
* Current diagnosis of cancer * Concurrent psychological therapy * Other severe psychiatric conditions (schizophrenia, delusional disorder, psychotic disorder, dissociative disorder, and active suicidality) * Any skin conditions on the hand (pain testing site) * Non-English speaker * No access to email or smart phone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Craving | At day 7 (after intervention) | Craving was assessed using a 0-100 Visual Analogue Scale (VAS), with higher scores indicating greater craving in the past 24 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cortisol | At day 7 (after intervention) | 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. |
| Anxiety Symptoms | At day 7 (after intervention) | 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. |
| Depression Symptoms | At day 7 (after intervention) | 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. |
| Prescription Opioid Misuse | At day 14 (7 days after intervention) | 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 |
Countries
United States
Contacts
Stanford University
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Coping Statement Daily practice of pain coping statements for 7 days
Coping Statement: Daily practice of coping statement | 44 |
| Control No instruction about pain coping statement. | 49 |
| Total | 93 |
Baseline characteristics
| Characteristic | Control | Total | Coping Statement |
|---|---|---|---|
| Age, Continuous | 61.6 years STANDARD_DEVIATION 9.83 | 61.0 years STANDARD_DEVIATION 11.6 | 60.4 years STANDARD_DEVIATION 13.4 |
| Opioid Craving Craving | 27 Participants | 54 Participants | 27 Participants |
| Opioid Craving Non-craving | 22 Participants | 38 Participants | 16 Participants |
| Race/Ethnicity, Customized African American/Black | 4 Participants | 4 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Pacific Islander/Native Hawaiian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Prefer not to say | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White/Caucasian | 37 Participants | 77 Participants | 40 Participants |
| Race/Ethnicity, Customized White/Hispanic/Latino | 4 Participants | 5 Participants | 1 Participants |
| Sex: Female, Male Female | 29 Participants | 54 Participants | 25 Participants |
| Sex: Female, Male Male | 20 Participants | 39 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 49 |
| other Total, other adverse events | 7 / 44 | 13 / 49 |
| serious Total, serious adverse events | 1 / 44 | 0 / 49 |
Outcome results
Craving
Craving was assessed using a 0-100 Visual Analogue Scale (VAS), with higher scores indicating greater craving in the past 24 hours.
Time frame: At day 7 (after intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Statement | Craving | 12.68 score on a scale | Standard Deviation 20.06 |
| Control | Craving | 18.49 score on a scale | Standard Deviation 27.76 |
Craving
Craving was assessed using a 0-100 Visual Analogue Scale (VAS), with higher scores indicating greater craving in the past 24 hours.
Time frame: At day 14 (7 days after intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Statement | Craving | 12.77 score on a scale | Standard Deviation 12.84 |
| Control | Craving | 21.40 score on a scale | Standard Deviation 22.92 |
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.
Time frame: At day 7 (after intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Statement | Anxiety Symptoms | 52.27 T-score | Standard Deviation 8.88 |
| Control | Anxiety Symptoms | 50.14 T-score | Standard Deviation 8.31 |
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.
Time frame: At day 14 (7 days after intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Statement | Anxiety Symptoms | 52.91 T-score | Standard Deviation 49.79 |
| Control | Anxiety Symptoms | 11.04 T-score | Standard Deviation 8.84 |
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.
Time frame: At day 7 (after intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Statement | Cortisol | 0.41 ug/dL | Standard Deviation 0.62 |
| Control | Cortisol | 0.84 ug/dL | Standard Deviation 3.19 |
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.
Time frame: At day 14 (7 days after intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Statement | Cortisol | 0.53 ug/dL | Standard Deviation 1.62 |
| Control | Cortisol | 0.35 ug/dL | Standard Deviation 0.41 |
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.
Time frame: At day 7 (after intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Statement | Depression Symptoms | 51.08 T-score | Standard Deviation 9.35 |
| Control | Depression Symptoms | 41.31 T-score | Standard Deviation 8.31 |
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.
Time frame: At day 14 (7 days after intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Statement | Depression Symptoms | 51.02 score on a scale | Standard Deviation 9.36 |
| Control | Depression Symptoms | 48.53 score on a scale | Standard Deviation 8.89 |
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
Time frame: At day 14 (7 days after intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Statement | Prescription Opioid Misuse | 8.30 total score on a scale | Standard Deviation 7.9 |
| Control | Prescription Opioid Misuse | 7.47 total score on a scale | Standard Deviation 6.67 |