Pain, Inflammation and Opioid Craving

Affective and Inflammatory Reactivity to Pain in Opioid Use Disorder

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04190563

Enrollment

Registered

2019-12-09

Start date

2021-05-04

Completion date

2025-07-31

Last updated

2026-08-13

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

Conditions

Opioid-use Disorder

Brief summary

The goal of this study is to investigate the association between response to pain and opioid craving in people with opioid use disorder. In this study, adults with opioid use disorder will be randomized to one of two brief education sessions followed by an assessment of response to pain. Investigators will test the association between response to pain and opioid craving.

Interventions

BEHAVIORALPain De-Catastrophizing

Experimenter-administered education and skill practice.

BEHAVIORALPain Education

Experimenter-administered education.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Investigator)

Masking description

The investigator and data analyst will be blind to study condition.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* age 18 years or older; * diagnosis of opioid use disorder * chronic pain * ability to read and provide informed consent

Exclusion criteria

* major psychiatric or medical condition that would interfere with participation * current opioid withdrawal * currently receiving opioid analgesic medication for pain * recent history of myocardial infarction or other serious cardiovascular condition * current peripheral neuropathy, active vasculitis or severe peripheral vascular disease * systematic inflammatory or autoimmune disorder * admitted to current treatment episode on an involuntary status

Design outcomes

Primary

Measure	Time frame	Description
Craving	immediately after the intervention	Investigators will assess opioid craving using the Opioid Craving Scale, a participant-reported measure of opioid craving. This is a continuous measure that is quantified as a total scale score representing an average of the 3 items, with a range from 0-10, with higher scores reflecting more craving. This outcome is the mean score at a single time point, immediately following completion of the intervention.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRebecca K McHugh, PhD

Mclean Hospital

Baseline characteristics

Characteristic	—
Age, Continuous	37.66 years STANDARD_DEVIATION 8.83
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	4 Participants
Race (NIH/OMB) More than one race	3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants
Race (NIH/OMB) White	61 Participants
Sex: Female, Male Female	28 Participants
Sex: Female, Male Male	25 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 38	0 / 45
other Total, other adverse events	0 / 38	0 / 45
serious Total, serious adverse events	0 / 38	0 / 45

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026