Opioid and Pain Cognition

NCT04132609 | Completed DMC

• 1 other identifier: 2000024242
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  17 weeks

Study Arms (2)

Cognitive Bias Intervention

ACTIVE COMPARATOR

Complete cognitive bias intervention task during methadone clinic visit 3x/wk for 4 weeks.

Behavioral: Cognitive bias modification

Control

PLACEBO COMPARATOR

Complete standard attentional bias intervention task during methadone clinic visit 3x/wk for 4 weeks.

Behavioral: Standard attentional bias

Interventions

Cognitive bias modification BEHAVIORAL

: 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.

Also known as: Cognitive task

Cognitive Bias Intervention

Standard attentional bias BEHAVIORAL

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.

Also known as: Cognitive task

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Veteran Affairs Hospital

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert R MacLean, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will complete the standard attentional bias task (control) or CBM up to 3x/week during MAT clinic visits for 4 weeks.

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: October 21, 2019
• Study Start: February 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: June 14, 2021

Record last verified: 2021-06

Locations

US (1)