Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03616379 · ClinicalTrials.gov registry record · NA
Stress Response in Opioid Use Disorder
A NA study, sponsored by Mclean Hospital.
- Completed
- Registry status
- NA
- Development phase
- 119
- Enrollment target
NCT03616379: Completed NA study, sponsored by Mclean Hospital.
NCT03616379 is a NA study that has completed, run by Mclean Hospital. The registered enrollment target is 119 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03616379, a NA study, has completed, sponsored by Mclean Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 119 participants
- Enrollment target
Study Summary
Opioid use disorder is a major public health problem. Although there are effective treatments for this disorder, many people still relapse and thus there is a need for new treatments to improve outcomes. People who have a strong emotional and physical response to stress are at a higher risk of relapse. The goal of this project is to test the effect of strategies to reduce response to stress in people diagnosed with opioid use disorder. Men and women diagnosed with opioid use disorder will be recruited for a one-session study. Participants will be randomly assigned to one of three brief instructional conditions followed by a brief laboratory stress test. Investigators hypothesize that, compared to education about stress, brief strategies to help people cope with negative emotions will reduce responses to stress and increase tolerance of stress. If this hypothesis is supported, it will inform the development of new treatments to improve outcome in opioid use disorder.
Primary Outcome
Negative affect will be measured using the Negative Affect Subscale of the Positive and Negative Affect Schedule. This is a 10-item self-report measure on which respondents rate how strongly they are experiencing negative emotion. The range of scores is 10-50, with higher scores representing higher negative affect.
Interventions
- BEHAVIORAL Psychoeducational Control
- BEHAVIORAL Affect Regulation
- BEHAVIORAL Affect Labelling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2019-05-31 |
| Est. Completion | 2022-08-31 |
| Phase | NA |
What the finished NCT03616379 record still lists
NCT03616379 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Psychoeducational Control is the first listed.
NCT03616379 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03616379 about?
NCT03616379 is a clinical study titled "Stress Response in Opioid Use Disorder". Opioid use disorder is a major public health problem. Although there are effective treatments for this disorder, many people still relapse and thus there is a need for new treatments to improve outcomes. People who have a strong emotional and physical response to stress are at a higher risk of relap...
What is the current status of trial NCT03616379?
This trial is currently completed. It is a NA study. The enrollment target is 119 participants. The study started on 2019-05-31. Estimated completion is 2022-08-31.
What interventions are being tested in trial NCT03616379?
The interventions under investigation include: Psychoeducational Control (BEHAVIORAL), Affect Regulation (BEHAVIORAL), Affect Labelling (BEHAVIORAL).
Who is sponsoring clinical trial NCT03616379?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03616379's enrollment target sits among peer trials
119 803rd of 2000 higher than 1,198 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04870762 · 119 participants · Phase 2
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
- NCT05559853 · 119 participants
Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment
- NCT06564389 · 119 participants · Phase 1
FIH Study to Evaluate the Tolerability of PF-07832837 in Healthy Adults and Patients
- NCT06742801 · 119 participants · NA
Onyx™ Liquid Embolic IDE Clinical Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI