Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
119 participants
INTERVENTIONAL
2019-05-31
2022-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Health Intervention Project
NCT02152397
Following Outcomes Remotely Within Addiction Recovery Domains
NCT06001437
Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl
NCT06089707
Pain, Inflammation and Opioid Craving
NCT04190563
Therapy and Peer Support for Patients Taking Medication for Opioid Use Disorder
NCT04257214
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.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Psychoeducational Control
Psychoeducational Control
The Psychoeducational Control condition will consist of a brief script describing the body's response to stress and will not discuss cognition or the role of interpretation or affect labeling during stress.
Affect Regulation Condition
Affect Regulation
In the Affect Regulation Condition, participants will be provided instructions for how to reappraise negative thoughts in the context of stress by developing statements consistent with more benign interpretations of stress (e.g., This won't last forever.).
Affect Labelling Condition
Affect Labelling
In the Affect Labeling Condition, participants will be provided with instructions for how to verbalize their emotional response during the stressor.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Psychoeducational Control
The Psychoeducational Control condition will consist of a brief script describing the body's response to stress and will not discuss cognition or the role of interpretation or affect labeling during stress.
Affect Regulation
In the Affect Regulation Condition, participants will be provided instructions for how to reappraise negative thoughts in the context of stress by developing statements consistent with more benign interpretations of stress (e.g., This won't last forever.).
Affect Labelling
In the Affect Labeling Condition, participants will be provided with instructions for how to verbalize their emotional response during the stressor.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* primary diagnosis of opioid use disorder
* ability to read and provide informed consent
Exclusion Criteria
* current opioid withdrawal
* presence of another current substance use disorder at a severity requiring acute treatment
* endocrine disease or current steroid prescription
* opioid-positive urine drug screen or breath alcohol test on the data or enrollment (not including prescribed medications)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mclean Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
McHugh, R. Kathryn
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
McLean Hospital
Belmont, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
McHugh RK, McCarthy MD, Bichon JA, Nguyen MD, Kneeland EK, Ellis RA, Dillon DG, Fitzmaurice GM. Effects of behavioral interventions on stress reactivity in adults with substance use disorders. Psychol Addict Behav. 2024 Dec;38(8):819-826. doi: 10.1037/adb0001032. Epub 2024 Sep 12.
McHugh RK, Nguyen MD, Fitzmaurice GM, Dillon DG. Behavioral strategies to reduce stress reactivity in opioid use disorder: Study design. Health Psychol. 2020 Sep;39(9):806-814. doi: 10.1037/hea0000862.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018P001419
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.