Clinical trial NCT03616379: Stress Response in Opioid Use Disorder
Official title: Behavioral Strategies to Reduce Stress Reactivity in Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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)

Primary outcomes:
measure: Change in Negative Affect
timeFrame: Change measured over 2 time points during this 1-session study experiment (from start of a stress induction task to completion; approximately 10-15 minutes).
measure: Distress Tolerance
timeFrame: Time-to-event outcome; during this 1-session study, this will measure time to outcome (discontinuation of task) from time of initiation of the stress induction task up to a maximum of 15 minutes later.
Secondary outcomes:
measure: Change in Cortisol Response
timeFrame: Change measured over 2 time points during this 1-session study (from start of stress induction task to 30 minutes after completion; approximately 40-45 minutes).
measure: Change in Skin Conductance Level
timeFrame: Change measured over 2 time points during this 1-session study (prior to and during the stress induction task; approximately 10-15 minutes).
measure: Change in Opioid Craving
timeFrame: Change measured over 2 time points during this 1-session study (immediately prior to and at the completion of the stress induction task; approximately 10-15 minutes).
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
References:
citation: 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.