PainopioidNCT04132609
Opioid and Pain Cognition
A study testing Cognitive bias modification and Standard attentional bias in people with Pain, run by Yale University at 1 site in United States.
Trial summary
The proposed research will provide foundational research to develop this low-burden behavioral intervention that can potentially improve outcomes of OUD. The Specific Aims of the proposal include conducting a pilot randomized controlled trial with post-intervention and 3 month follow up to evaluate feasibility… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Cognitive bias modification and Standard attentional bias
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Veterans that meet DSM5 criteria for OUD
- Be engaged in Methadone Maintained Program
- Report clinically significant past-week pain intensity (i.e., at least moderate pain severity)
Who cannot join
- The inability to read, write and speak English
- Active suicidal ideation
- Diagnosis of psychotic disorder
- Use of drugs that interact negatively with MAT (e.g. benzodiazepines), and
- uncorrected defective vision, which would interfere completing the dot probe task
Trial locations and contacts
1 site in 1 country.
United States1 site
Veteran Affairs Hospital
West Haven, Connecticut, 06516
About this study
Official title: Opioid and Pain Cognitive Bias Modification in Opioid Use Disorder
The proposed research will provide foundational research to develop this low-burden behavioral intervention that can potentially improve outcomes of OUD. The Specific Aims of the proposal include conducting a pilot randomized controlled trial with post-intervention and 3 month follow up to evaluate feasibility, acceptability, and preliminary effectiveness of CBM task for opioid and pain cues (Aim 1), examine naturalistic assessment of opioid craving and pain intensity/interference (Aim 2), and conduct qualitative analysis of Veterans experiences of adjunctive treatment in MAT clinic and perceptions of CBM as an intervention (Aim 3). Male and female Veterans meeting DSM5 criteria for OUD (N=60) currently on MAT will be randomly assigned to 4 weeks of CBM for opioid and pain cues or control (standard attentional bias). CBM/control tasks will be administered during weekly MAT clinic appointments and opioid craving and pain intensity/interference will be randomly assessed during the day using a mobile device. Post-intervention, Veterans will be invited to participate in a digitally recorded semi-structured interview for qualitative assessment of CBM and treatment adjunctive to MAT. MAT outcomes (urine toxicology screens, MAT appointments) will also be measured at 3-month follow up. The current study will elucidate dynamic relationships between attention to opioid and pain cues and whether modifying attention can reduce risk factors associated with treatment failure. If successful, with its low patient and provider burden, CBM could be readily incorporated in research and clinical practice as an adjunctive treatment for OUD.
Read the detailed description
Participants will complete the standard attentional bias task (control) or CBM up to 3x/week during MAT clinic visits for 4 weeks.
Attentional bias: Attentional bias will be assessed during MAT clinic visits using the visual probe task, which is considered the gold standard to evaluate vigilance to salient cues. In the standard attentional bias task, a drug or pain-related word is presented next to a neutral word for 500ms. Subsequently, a probe (i.e., a "q" or "p") replaces the drug/pain word or the neutral word at an equal rate. The participant's task is to indicate the location of the probe as quickly as possible by pressing "q" or "p". Attentional bias is calculated from the difference in reaction times (i.e., neutral cue minus drug/pain cue) to indicate the location of the probe, with higher values indicating greater attentional bias. For all tasks, opioid and pain words will be presented in separate blocks in counterbalanced order. Neutral words paired with opioid or pain words will be matched for length and frequency of use in the English language. Opioid (e.g., syringe, needle, high, blues) and pain sensory (e.g., stuff, throbbing, shooting, burning) and affective (e.g., miserable, tiring, unbearable, exhausting) words will be taken from prior research demonstrating attentional bias in OUD and chronic pain patients.
CBM treatment: In CBM, the task presentation and timing is the same as attentional bias, except the probe always replaces the neutral word. It ensures that: 1) the duration of CBM and control training should not differ; 2) CBM and control participants receive equal practice on the motoric aspects of the task; and 3) CBM and control participants are exposed to the same word cues. Based on previous data, duration of CBM and control trainings will be about 10 minutes.
- Conditions
- Pain
- Being tested
- Cognitive bias modification, Standard attentional bias
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive bias modificationBehavioural
Also called Cognitive task
: In CBM, the task presentation and timing is the same as attentional bias, except the probe always replaces the neutral word. It ensures that: 1) the duration of CBM and control training should not differ; 2) CBM and control participants receive equal practice on the motoric aspects of the task; and 3) CBM and control participants are exposed to the same word cues. Based on previous data, duration of CBM and control trainings will be about 10 minutes.
Standard attentional biasBehavioural
Also called Cognitive task
the standard attentional bias task, a drug or pain-related word is presented next to a neutral word for 500ms. Subsequently, a probe (i.e., a "q" or "p") replaces the drug/pain word or the neutral word at an equal rate. The participant's task is to indicate the location of the probe as quickly as possible by pressing "q" or "p". Attentional bias is calculated from the difference in reaction times (i.e., neutral cue minus drug/pain cue) to indicate the location of the probe, with higher values indicating greater attentional bias. For all tasks, opioid and pain words will be presented in separate blocks in counterbalanced order. Neutral words paired with opioid or pain words will be matched for length and frequency of use in the English language.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Bias Intervention | Active comparator | Complete cognitive bias intervention task during methadone clinic visit 3x/wk for 4 weeks. Receives: Behavioral: Cognitive bias modification |
| Control | Placebo comparator | Complete standard attentional bias intervention task during methadone clinic visit 3x/wk for 4 weeks. Receives: Behavioral: Standard attentional bias |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related Adverse events
The treatment-related adverse events will be measured as the number of participants assessed by cognitive behavior modification using an eprime task to compare the number of correct answers.
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start1 Feb 2019
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will complete the standard attentional bias task (control) or CBM up to 3x/week during MAT clinic visits for 4 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Robert R MacLean, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132609
- Sponsor's protocol ID
- 2000024242
- Acronym
- opioid
- Status last verified
- Jun 2021
- First submitted
- 16 Jul 2019
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid and Pain Cognitive Bias Modification in Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04132609
- Acronym / sponsor ID
- opioid / 2000024242
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed research will provide foundational research to develop this low-burden behavioral intervention that can potentially improve outcomes of OUD. The Specific Aims of the proposal include conducting a pilot randomized controlled trial with post-intervention and 3 month follow up to evaluate feasibility, acceptability, and preliminary effectiveness of CBM task for opioid and pain cues (Aim 1), examine naturalistic assessment of opioid craving and pain intensity/interference (Aim 2), and conduct qualitative analysis of Veterans experiences of adjunctive treatment in MAT clinic and perceptions of CBM as an intervention (Aim 3). Male and female Veterans meeting DSM5 criteria for OUD (N=60) currently on MAT will be randomly assigned to 4 weeks of CBM for opioid and pain cues or control (standard attentional bias). CBM/control tasks will be administered during weekly MAT clinic appointments and opioid craving and pain intensity/interference will be randomly assessed during the day using a mobile device. Post-intervention, Veterans will be invited to participate in a digitally recorded semi-structured interview for qualitative assessment of CBM and treatment adjunctive to MAT. MAT outcomes (urine toxicology screens, MAT appointments) will also be measured at 3-month follow up. The current study will elucidate dynamic relationships between attention to opioid and pain cues and whether modifying attention can reduce risk factors associated with treatment failure. If successful, with its low patient and provider burden, CBM could be readily incorporated in research and clinical practice as an adjunctive treatment for OUD.
Detailed description
Participants will complete the standard attentional bias task (control) or CBM up to 3x/week during MAT clinic visits for 4 weeks.
Attentional bias: Attentional bias will be assessed during MAT clinic visits using the visual probe task, which is considered the gold standard to evaluate vigilance to salient cues. In the standard attentional bias task, a drug or pain-related word is presented next to a neutral word for 500ms. Subsequently, a probe (i.e., a "q" or "p") replaces the drug/pain word or the neutral word at an equal rate. The participant's task is to indicate the location of the probe as quickly as possible by pressing "q" or "p". Attentional bias is calculated from the difference in reaction times (i.e., neutral cue minus drug/pain cue) to indicate the location of the probe, with higher values indicating greater attentional bias. For all tasks, opioid and pain words will be presented in separate blocks in counterbalanced order. Neutral words paired with opioid or pain words will be matched for length and frequency of use in the English language. Opioid (e.g., syringe, needle, high, blues) and pain sensory (e.g., stuff, throbbing, shooting, burning) and affective (e.g., miserable, tiring, unbearable, exhausting) words will be taken from prior research demonstrating attentional bias in OUD and chronic pain patients.
CBM treatment: In CBM, the task presentation and timing is the same as attentional bias, except the probe always replaces the neutral word. It ensures that: 1) the duration of CBM and control training should not differ; 2) CBM and control participants receive equal practice on the motoric aspects of the task; and 3) CBM and control participants are exposed to the same word cues. Based on previous data, duration of CBM and control trainings will be about 10 minutes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will complete the standard attentional bias task (control) or CBM up to 3x/week during MAT clinic visits for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Bias Intervention | Active comparator | Behavioral: Cognitive bias modificationComplete cognitive bias intervention task during methadone clinic visit 3x/wk for 4 weeks. |
| Control | Placebo comparator | Behavioral: Standard attentional biasComplete standard attentional bias intervention task during methadone clinic visit 3x/wk for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Veterans that meet DSM5 criteria for OUD
- Be engaged in Methadone Maintained Program
- Report clinically significant past-week pain intensity (i.e., at least moderate pain severity)
Key exclusion criteria (5 listed)
- The inability to read, write and speak English
- Active suicidal ideation
- Diagnosis of psychotic disorder
- Use of drugs that interact negatively with MAT (e.g. benzodiazepines), and
- uncorrected defective vision, which would interfere completing the dot probe task
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 |
|---|---|---|
| Cognitive bias modificationAlso: Cognitive task: In CBM, the task presentation and timing is the same as attentional bias, except the probe always replaces the neutral word. It ensures that: 1) the duration of CBM and control training should not differ; 2) CBM and control participants receive equal practice on the motoric aspects of the task; and 3) CBM and control participants are exposed to the same word cues. Based on previous data, duration of CBM and control trainings will be about 10 minutes. | Behavioural | Cognitive Bias Intervention |
| Standard attentional biasAlso: Cognitive taskthe standard attentional bias task, a drug or pain-related word is presented next to a neutral word for 500ms. Subsequently, a probe (i.e., a "q" or "p") replaces the drug/pain word or the neutral word at an equal rate. The participant's task is to indicate the location of the probe as quickly as possible by pressing "q" or "p". Attentional bias is calculated from the difference in reaction times (i.e., neutral cue minus drug/pain cue) to indicate the location of the probe, with higher values indicating greater attentional bias. For all tasks, opioid and pain words will be presented in separate blocks in counterbalanced order. Neutral words paired with opioid or pain words will be matched for length and frequency of use in the English language. | Behavioural | Control |
Primary outcome
Treatment-related Adverse events
Time frame: 17 weeks
The treatment-related adverse events will be measured as the number of participants assessed by cognitive behavior modification using an eprime task to compare the number of correct answers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
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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.
Robert R MacLean, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive bias modification and Standard attentional bias in people with Pain, run by Yale University 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 14 Jun 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment-related Adverse events (time frame: 17 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2021.