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Opioid and Pain Cognition (opioid)

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ClinicalTrials.gov Identifier: NCT04132609
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
Yale University

Brief 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, 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.

Condition or disease Intervention/treatment Phase
Pain Behavioral: Cognitive bias modification Behavioral: Standard attentional bias Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Opioid and Pain Cognitive Bias Modification in Opioid Use Disorder
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : March 1, 2021

Arm Intervention/treatment
Active Comparator: Cognitive Bias Intervention
Complete cognitive bias intervention task during methadone clinic visit 3x/wk for 4 weeks.
Behavioral: Cognitive bias modification
: 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.
Other Name: Cognitive task

Placebo Comparator: Control
Complete standard attentional bias intervention task during methadone clinic visit 3x/wk for 4 weeks.
Behavioral: Standard attentional bias
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.
Other Name: Cognitive task




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132609


Contacts
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Contact: Robert R MacLean, Ph.D. 203 ext 932-577 ross.maclean@yale.edu

Locations
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United States, Connecticut
Veteran Affairs Hospital Recruiting
West Haven, Connecticut, United States, 06516
Contact: Robert R Maclean, Ph.D.    203-932-5711 ext 7423    ross.maclean@yale.edu   
Principal Investigator: Robert R MacLean, Ph.D.         
Sponsors and Collaborators
Yale University
US Department of Veterans Affairs
Investigators
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Principal Investigator: Robert R MacLean, Ph.D. Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04132609     History of Changes
Other Study ID Numbers: 200002242
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents