Pain, Inflammation and Opioid Craving

NCT ID: NCT04190563

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-04

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid-use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pain De-Catastrophizing

Brief behavioral education on how to modify the interpretation of pain.

Group Type EXPERIMENTAL

Pain De-Catastrophizing

Intervention Type BEHAVIORAL

Experimenter-administered education and skill practice.

Pain Education

Brief behavioral education on pain.

Group Type PLACEBO_COMPARATOR

Pain Education

Intervention Type BEHAVIORAL

Experimenter-administered education.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pain De-Catastrophizing

Experimenter-administered education and skill practice.

Intervention Type BEHAVIORAL

Pain Education

Experimenter-administered education.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

McHugh, R. Kathryn

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rebecca K McHugh, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

McLean Hospital

Belmont, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01DA045632

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019P002720

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Adversity, Brain and Opioid Use Study
NCT06355778 RECRUITING NA