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Opioid and Pain Cognition (opioid)

Yale University logo

Yale University

Status

Completed

Conditions

Pain

Treatments

Behavioral: Standard attentional bias
Behavioral: Cognitive bias modification

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT04132609
2000024242

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

20 participants in 2 patient groups, including a placebo group

Cognitive Bias Intervention
Active Comparator group
Description:
Complete cognitive bias intervention task during methadone clinic visit 3x/wk for 4 weeks.
Treatment:
Behavioral: Cognitive bias modification
Control
Placebo Comparator group
Description:
Complete standard attentional bias intervention task during methadone clinic visit 3x/wk for 4 weeks.
Treatment:
Behavioral: Standard attentional bias

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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