Mode
Text Size
Log in / Sign up
N/A N=119 Randomized Single-blind Other

Stress Response in Opioid Use Disorder

Opioid-use Disorder

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

OutcomeResultp-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)
View full record on ClinicalTrials.gov →

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.

Back to search