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Pain Catastrophizing and Prescription Opioid Craving

Effect of Pain Catastrophizing on Prescription Opioid Craving

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04097743
Enrollment
93
Registered
2019-09-20
Start date
2021-06-29
Completion date
2024-12-10
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

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

BEHAVIORALCoping Statement

Daily practice of coping statement

Sponsors

Stanford University
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
CravingAt 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

MeasureTime frameDescription
CortisolAt 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 SymptomsAt 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 SymptomsAt 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 MisuseAt 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

PRINCIPAL_INVESTIGATORDokyoung S You, PhD

Stanford University

Participant flow

Participants by arm

ArmCount
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
Total93

Baseline characteristics

CharacteristicControlTotalCoping Statement
Age, Continuous61.6 years
STANDARD_DEVIATION 9.83
61.0 years
STANDARD_DEVIATION 11.6
60.4 years
STANDARD_DEVIATION 13.4
Opioid Craving
Craving
27 Participants54 Participants27 Participants
Opioid Craving
Non-craving
22 Participants38 Participants16 Participants
Race/Ethnicity, Customized
African American/Black
4 Participants4 Participants0 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Asian
2 Participants4 Participants2 Participants
Race/Ethnicity, Customized
Other
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Pacific Islander/Native Hawaiian
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Prefer not to say
2 Participants2 Participants0 Participants
Race/Ethnicity, Customized
White/Caucasian
37 Participants77 Participants40 Participants
Race/Ethnicity, Customized
White/Hispanic/Latino
4 Participants5 Participants1 Participants
Sex: Female, Male
Female
29 Participants54 Participants25 Participants
Sex: Female, Male
Male
20 Participants39 Participants19 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 440 / 49
other
Total, other adverse events
7 / 4413 / 49
serious
Total, serious adverse events
1 / 440 / 49

Outcome results

Primary

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)

ArmMeasureValue (MEAN)Dispersion
Coping StatementCraving12.68 score on a scaleStandard Deviation 20.06
ControlCraving18.49 score on a scaleStandard Deviation 27.76
p-value: 0.41ANOVA
Primary

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)

ArmMeasureValue (MEAN)Dispersion
Coping StatementCraving12.77 score on a scaleStandard Deviation 12.84
ControlCraving21.40 score on a scaleStandard Deviation 22.92
p-value: 0.81ANOVA
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.

Time frame: At day 7 (after intervention)

ArmMeasureValue (MEAN)Dispersion
Coping StatementAnxiety Symptoms52.27 T-scoreStandard Deviation 8.88
ControlAnxiety Symptoms50.14 T-scoreStandard Deviation 8.31
p-value: 0.99ANOVA
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.

Time frame: At day 14 (7 days after intervention)

ArmMeasureValue (MEAN)Dispersion
Coping StatementAnxiety Symptoms52.91 T-scoreStandard Deviation 49.79
ControlAnxiety Symptoms11.04 T-scoreStandard Deviation 8.84
p-value: 0.49ANOVA
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.

Time frame: At day 7 (after intervention)

ArmMeasureValue (MEAN)Dispersion
Coping StatementCortisol0.41 ug/dLStandard Deviation 0.62
ControlCortisol0.84 ug/dLStandard Deviation 3.19
p-value: 0.39ANOVA
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.

Time frame: At day 14 (7 days after intervention)

ArmMeasureValue (MEAN)Dispersion
Coping StatementCortisol0.53 ug/dLStandard Deviation 1.62
ControlCortisol0.35 ug/dLStandard Deviation 0.41
p-value: 0.67ANOVA
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.

Time frame: At day 7 (after intervention)

ArmMeasureValue (MEAN)Dispersion
Coping StatementDepression Symptoms51.08 T-scoreStandard Deviation 9.35
ControlDepression Symptoms41.31 T-scoreStandard Deviation 8.31
p-value: 0.67ANOVA
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.

Time frame: At day 14 (7 days after intervention)

ArmMeasureValue (MEAN)Dispersion
Coping StatementDepression Symptoms51.02 score on a scaleStandard Deviation 9.36
ControlDepression Symptoms48.53 score on a scaleStandard Deviation 8.89
p-value: 0.89ANOVA
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

Time frame: At day 14 (7 days after intervention)

ArmMeasureValue (MEAN)Dispersion
Coping StatementPrescription Opioid Misuse8.30 total score on a scaleStandard Deviation 7.9
ControlPrescription Opioid Misuse7.47 total score on a scaleStandard Deviation 6.67
p-value: 0.08ANOVA

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026