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Stress Response in Opioid Use Disorder

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Mass General Brigham

Status

Completed

Conditions

Opioid-use Disorder

Treatments

Behavioral: Psychoeducational Control
Behavioral: Affect Regulation
Behavioral: Affect Labelling

Study type

Interventional

Funder types

Other

Identifiers

NCT03616379
2018P001419

Details and patient eligibility

About

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.

Enrollment

119 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

119 participants in 3 patient groups, including a placebo group

Psychoeducational Control
Placebo Comparator group
Treatment:
Behavioral: Psychoeducational Control
Affect Regulation Condition
Experimental group
Treatment:
Behavioral: Affect Regulation
Affect Labelling Condition
Experimental group
Treatment:
Behavioral: Affect Labelling

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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