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OpenTrials
Completed

NCT Number: NCT04190563

Pain, Inflammation and Opioid Craving

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pain De-Catastrophizing

Behavioral

Experimenter-administered education and skill practice.

Pain education

Behavioral

Experimenter-administered education.

Primary outcomes

  1. Craving

    Time frame: 30 minutes

    Investigators will assess opioid craving using the Opioid Craving Scale, a participant-reported measure of opioid craving. Investigators will measure changes in Opioid Craving Scale total scores from baseline (prior to the one-time intervention) to immediately after the intervention. This is a continuous measure that will be measured twice within this single-session experimental session. The total scale score is calculated as an average of the 3 items, with a range from 0-10, with higher scores reflecting more craving.

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Affective and Inflammatory Reactivity to Pain in Opioid Use Disorder

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2019
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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