Opioid-use DisorderNCT03616379
Stress Response in Opioid Use Disorder
A study testing Affect Regulation and Affect Labelling in people with Opioid-use Disorder, run by Mclean Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Affect Regulation and Affect Labelling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2019to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- primary diagnosis of opioid use disorder
- ability to read and provide informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Behavioral Strategies to Reduce Stress Reactivity 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 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.
- Conditions
- Opioid-use Disorder
- Being tested
- Psychoeducational Control, Affect Regulation, Affect Labelling
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational ControlBehavioural
The Psychoeducational Control condition will consist of a brief script describing the body's response to stress and will not discuss cognition or the role of interpretation or affect labeling during stress.
Affect RegulationBehavioural
In the Affect Regulation Condition, participants will be provided instructions for how to reappraise negative thoughts in the context of stress by developing statements consistent with more benign interpretations of stress (e.g., This won't last forever.).
Affect LabellingBehavioural
In the Affect Labeling Condition, participants will be provided with instructions for how to verbalize their emotional response during the stressor.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducational Control | Placebo comparator | Not described Receives: Behavioral: Psychoeducational Control |
| Affect Regulation Condition | Experimental | Not described Receives: Behavioral: Affect Regulation |
| Affect Labelling Condition | Experimental | Not described Receives: Behavioral: Affect Labelling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Negative Affect
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.
Measured: 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).
Distress Tolerance
Distress tolerance will be measured using the Computerized Mirror Tracing Persistence Task. This is a computer-based task in which participants trace a mirror on the screen using the cursor. Participants are asked to persist at the task for as long as possible. Time to discontinuation is used as a measure of distress tolerance (in seconds). Longer duration reflects better tolerance of distress.
Measured: 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 (3)
Change in Cortisol Response
Cortisol levels will be measured using saliva samples. Salivary cortisol levels are measured on a continuous scale (micrograms/deciliter).
Measured: 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).
Change in Skin Conductance Level
Skin conductance level is a physiological outcome that will be measured using electrodes placed on participants fingers, connected to a Biopac MP150 system with an ECG amplifier. Change will be measures by subtracting the maximum value during the stress task from the value at the end of a baseline recording.
Measured: Change measured over 2 time points during this 1-session study (prior to and during the stress induction task; approximately 10-15 minutes).
Change in Opioid Craving
Self-report of opioid craving will be measured using the Opioid Craving Scale, a 3-item measure, with a range of 0-30, with higher scores representing strong opioid craving.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start31 May 2019
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, McHugh, R. Kathryn, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616379
- Sponsor's protocol ID
- 2018P001419
- Status last verified
- Mar 2024
- First submitted
- 5 Jul 2018
- Last updated
- 1 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: In accordance with NIH policies for data sharing, data resulting from this project will be made available to qualified individuals within the scientific community. By data, this means the recorded, factual material necessary to document and support the research findings. Data will first be checked in accordance with the Data Safety and Monitoring Plan to ensure accuracy and completeness. To comply with pertinent local and federal regulations regarding the confidentiality of research data, any shared data would be free of identifiers that would permit linkage to research participants, and free of content that would create unacceptably high risks of subject identification. Data will be available to other researchers upon request to the study PI through a data sharing agreement after the primary paper has been accepted for publication in compliance with the NIH policy for the timely release and sharing of data.
Publications
McHugh RK, McCarthy MD, Bichon JA, Nguyen MD, Kneeland EK, Ellis RA, Dillon DG, Fitzmaurice GM. Effects of behavioral interventions on stress reactivity in adults with substance use disorders. Psychol Addict Behav. 2024 Dec;38(8):819-826. doi: 10.1037/adb0001032. Epub 2024 Sep 12.
PubMed 39264682McHugh 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.
PubMed 32833482
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Strategies to Reduce Stress Reactivity in Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT03616379
- Acronym / sponsor ID
- 2018P001419
- Conditions
- Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Posted 1 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psychoeducational Control | Placebo comparator | Behavioral: Psychoeducational Control |
| Affect Regulation Condition | Experimental | Behavioral: Affect Regulation |
| Affect Labelling Condition | Experimental | Behavioral: Affect Labelling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- primary diagnosis of opioid use disorder
- ability to read and provide informed consent
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational ControlThe Psychoeducational Control condition will consist of a brief script describing the body's response to stress and will not discuss cognition or the role of interpretation or affect labeling during stress. | Behavioural | Psychoeducational Control |
| Affect RegulationIn the Affect Regulation Condition, participants will be provided instructions for how to reappraise negative thoughts in the context of stress by developing statements consistent with more benign interpretations of stress (e.g., This won't last forever.). | Behavioural | Affect Regulation Condition |
| Affect LabellingIn the Affect Labeling Condition, participants will be provided with instructions for how to verbalize their emotional response during the stressor. | Behavioural | Affect Labelling Condition |
Primary outcome
Change in Negative Affect
Time frame: 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).
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.
Distress Tolerance
Time frame: 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.
Distress tolerance will be measured using the Computerized Mirror Tracing Persistence Task. This is a computer-based task in which participants trace a mirror on the screen using the cursor. Participants are asked to persist at the task for as long as possible. Time to discontinuation is used as a measure of distress tolerance (in seconds). Longer duration reflects better tolerance of distress.
3 secondary outcomes
Change in Cortisol Response
Time frame: 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).
Change in Skin Conductance Level
Time frame: Change measured over 2 time points during this 1-session study (prior to and during the stress induction task; approximately 10-15 minutes).
Change in Opioid Craving
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39264682McHugh RK, McCarthy MD, Bichon JA, Nguyen MD, Kneeland EK, Ellis RA, Dillon DG, Fitzmaurice GM. Effects of behavioral interventions on stress reactivity in adults with substance use disorders. Psychol Addict Behav. 2024 Dec;38(8):819-826. doi: 10.1037/adb0001032. Epub 2024 Sep 12.
- Derived from this study: PubMed 32833482McHugh 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.
- Individual participant dataSharing planned: Undecided. In accordance with NIH policies for data sharing, data resulting from this project will be made available to qualified individuals within the scientific community. By data, this means the recorded, factual material necessary to document and support the research findings. Data will first be checked in accordance with the Data Safety and Monitoring Plan to ensure accuracy and completeness. To comply with pertinent local and federal regulations regarding the confidentiality of research data, any shared data would be free of identifiers that would permit linkage to research participants, and free of content that would create unacceptably high risks of subject identification. Data will be available to other researchers upon request to the study PI through a data sharing agreement after the primary paper has been accepted for publication in compliance with the NIH policy for the timely release and sharing of data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Affect Regulation and Affect Labelling in people with Opioid-use Disorder, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Negative Affect (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03616379, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.