N/A
N=119
Stress Response in Opioid Use Disorder
Opioid-use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03616379 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Change in Negative Affect — 1.67; 1.25; 3.60 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Psychoeducational Control (Behavioral); Affect Regulation (Behavioral); Affect Labelling (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mclean Hospital
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Negative Affect |
1.67; 1.25; 3.60 | — |
| PRIMARY Distress Tolerance |
244.72; 227.07; 217.34 | — |
| SECONDARY Change in Cortisol Response |
-0.07; -0.07; -0.63 | — |
| SECONDARY Change in Skin Conductance Level |
0.68; 0.80; 1.16 | — |
| SECONDARY Change in Opioid Craving |
-0.26; -0.18; 0.60 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 18 years or older
- primary diagnosis of opioid use disorder
- ability to read and provide informed consent
Exclusion Criteria
- major psychiatric or medical condition that would interfere with the ability to complete study procedures
- 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)
Data sourced from ClinicalTrials.gov (NCT03616379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.