Opioid-use DisorderNCT04190563
Pain, Inflammation and Opioid Craving
A study testing Pain De-Catastrophizing and Pain Education in people with Opioid-use Disorder, run by Mclean Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Pain De-Catastrophizing and Pain Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2021to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or older;
- diagnosis of opioid use disorder
- chronic pain
- ability to read and provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Affective and Inflammatory Reactivity to Pain in Opioid Use Disorder
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.
- Conditions
- Opioid-use Disorder
- Being tested
- Pain De-Catastrophizing, Pain Education
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain De-CatastrophizingBehavioural
Experimenter-administered education and skill practice.
Pain EducationBehavioural
Experimenter-administered education.
| Study group | Role | What they receive |
|---|---|---|
| Pain De-Catastrophizing | Experimental | Brief behavioral education on how to modify the interpretation of pain. Receives: Behavioral: Pain De-Catastrophizing |
| Pain Education | Placebo comparator | Brief behavioral education on pain. Receives: Behavioral: Pain Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving
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.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start4 May 2021
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, McHugh, R. Kathryn, Mclean Hospital
- Investigators
- Rebecca K McHugh, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190563
- Sponsor's protocol ID
- 2019P002720
- Other IDs
- R01DA045632
- Status last verified
- Aug 2026
- First submitted
- 5 Dec 2019
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affective and Inflammatory Reactivity to Pain in Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04190563
- Acronym / sponsor ID
- 2019P002720
- Conditions
- Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 May 2021 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 9 Dec 2019 (actual)
- Results
- Posted 13 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain De-Catastrophizing | Experimental | Behavioral: Pain De-CatastrophizingBrief behavioral education on how to modify the interpretation of pain. |
| Pain Education | Placebo comparator | Behavioral: Pain EducationBrief behavioral education on pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or older;
- diagnosis of opioid use disorder
- chronic pain
- ability to read and provide informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain De-CatastrophizingExperimenter-administered education and skill practice. | Behavioural | Pain De-Catastrophizing |
| Pain EducationExperimenter-administered education. | Behavioural | Pain Education |
Primary outcome
Craving
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca K McHugh, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain De-Catastrophizing and Pain Education in people with Opioid-use Disorder, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craving (time frame: immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.