Opioid Use Disorder and Pain

NCT06800703 | Recruiting

• 2 other identifiers: 20000391214R00AA029716-03
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to characterize the brain processes of pain avoidance learning dysfunctions in individuals with opioid use disorder (OUD). The main questions it aims to answer are: Compared with healthy controls, do those with OUD exhibit impaired avoidance learning in response to pain? What are the brain processes that are associated with this avoidance learning dysfunction? Do these brain processes serve to predict future use or relapse? Researchers will compare those with OUD and healthy controls to determine avoidance learning dysfunction and its relationship with opioid use. Participants will be performing a learning task inside an fMRI scanner. Those with OUD will also be followed up for a year to determine future opioid use.

Conditions

Opioid Use Disorder; Healthy Controls Group - Age and Sex-matched

Keywords

opioid use disorder; pain; avoidance learning; prediction

Outcome Measures

Primary Outcomes (3)

• Avoidance learning measure

  Task performance measure of avoidance learning, quantified by response time and performance accuracy. Those with OUD are expected to have lower performance accuracy, lower learning rates, and higher response time during avoidance learning relative to healthy controls

  Day 1 (immediately after consent and clinical assessment)

• opioid use

  Quantity of opioid use following the baseline visit, measured by times use per week. Timeline follow back method will be used to assess the quantity of opioid use during the follow-up period. The investigators will examine this opioid use quantity in relation with avoidance learning deficits. The investigators expect greater avoidance dysfunction at baseline to predict higher weekly use of opioids

  During the 12-month follow-up period

• Brain activity during avoidance learning

  The brain activation magnitude associated with avoidance learning and avoidance learning dysfunction during the task performance. Brain activation will be computed by using contrast between avoidance learning vs. neutral conditions. Contrasts between two subject groups (i.e., OUD vs. HC) will also be examined. The investigators expect OUD patients to exhibit greater activations in the pain circuit during avoidance learning relative to healthy controls. Additionally, pain circuit activation will be assessed in association with opioid use severity during follow-up period.

  Day 1 (immediately after consent and clinical assessment)

Secondary Outcomes (3)

• Comparison of avoidance learning rate between women and men

  Day 1 (immediately after consent and clinical assessment)

• Comparison of brain activity during avoidance learning between women and men

  Day 1 (immediately after consent and clinical assessment)

• Relationship between sex differences in avoidance learning and opioid use

  Day 1 (immediately after consent and clinical assessment)

Study Arms (2)

opioid use disorder

individuals with OUD diagnosis

Behavioral: follow up interviews for 12 months to determine opioid use

Healthy controls

Healthy individuals without substance use disorders

Interventions

follow up interviews for 12 months to determine opioid use BEHAVIORAL

Follow-up

opioid use disorder

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Treatment-seeking OUD patients will be recruited from local clinics. Those with OUD not seeking treatment and healthy controls will be recruited from New Haven and surrounding areas in Connecticut.

You may not qualify if:

• Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, hepatic, thyroid pathology.
• History of head injury with loss of consciousness (\> 30 minutes).
• Current or past DSM-IV or DSM 5 diagnosis of a major psychiatric disorder (other than opioid and nicotine use disorders) that required hospitalization, or that required daily medications for over 4 weeks. Such medications include antidepressants, anticholinergics, antipsychotics, anxiolytics, lithium, psychotropic drugs not otherwise specified including herbal products, drugs with psychomotor effects or with anxiolytics, stimulant, or antipsychotic properties, any other psychoactive drugs, and sedatives/hypnotics. Individuals with current depressive or anxiety symptoms requiring treatment or currently being treated for these symptoms will be excluded.
• Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded. Individuals who previously worked in metal industry or with metal shavings (due to a risk of any remaining metal particles moving in the eye during the MRI).
• Pregnant or lactating women will not be recruited for the study.
• Cannot or are not willing to lie comfortably flat on his/her back for up to 2 hours in the MRI scanner (self-report).
• Body weight \> 550 lbs. The MR scanner bed is tested to a weight limit of 550 lbs.
• No pPlans to relocate out of state in the next 12 months (for follow-up purposes).
• Still experiencing significant withdrawal symptoms.
• Individuals with regular opioid use
• Between ages 21-60 years old.
• Able to read and write and provide written informed consent.
• Use non-prescribed opioids on a weekly basis or more.
• Physically healthy with no major medical illnesses, history of head injury or any neurological illness
• No plans to relocate out of state in the next 12 months (for follow-up purposes).

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Brain and Behavior Research Foundation (previously known as NARSAD): collaborator

Study Sites (1)

Connecticut Mental Health Center, S105

New Haven, Connecticut, 06519, United States

RECRUITING

Related Publications (8)

• Baker TB, Piper ME, McCarthy DE, Majeskie MR, Fiore MC. Addiction motivation reformulated: an affective processing model of negative reinforcement. Psychol Rev. 2004 Jan;111(1):33-51. doi: 10.1037/0033-295X.111.1.33.

  PMID: 14756584 RESULT

• Carcoba LM, Contreras AE, Cepeda-Benito A, Meagher MW. Negative affect heightens opiate withdrawal-induced hyperalgesia in heroin dependent individuals. J Addict Dis. 2011 Jul-Sep;30(3):258-70. doi: 10.1080/10550887.2011.581985.

  PMID: 21745048 RESULT

• Ren ZY, Shi J, Epstein DH, Wang J, Lu L. Abnormal pain response in pain-sensitive opiate addicts after prolonged abstinence predicts increased drug craving. Psychopharmacology (Berl). 2009 Jun;204(3):423-9. doi: 10.1007/s00213-009-1472-0. Epub 2009 Jan 27.

  PMID: 19172249 RESULT

• Grella CE, Lovinger K. 30-year trajectories of heroin and other drug use among men and women sampled from methadone treatment in California. Drug Alcohol Depend. 2011 Nov 1;118(2-3):251-8. doi: 10.1016/j.drugalcdep.2011.04.004. Epub 2011 May 6.

  PMID: 21549528 RESULT

• Le TM, Zhornitsky S, Wang W, Zhang S, Li CR. Problem drinking alters gray matter volume and food cue responses of the lateral orbitofrontal cortex. Addict Biol. 2021 Jan;26(1):e12857. doi: 10.1111/adb.12857. Epub 2019 Nov 20.

  PMID: 31746092 RESULT

• Wang W, Zhornitsky S, Le TM, Zhang S, Li CR. Heart Rate Variability, Cue-Evoked Ventromedial Prefrontal Cortical Response, and Problem Alcohol Use in Adult Drinkers. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Jun;5(6):619-628. doi: 10.1016/j.bpsc.2019.12.013. Epub 2019 Dec 30.

  PMID: 32061544 RESULT

• Le TM, Chao H, Levy I, Li CR. Age-Related Changes in the Neural Processes of Reward-Directed Action and Inhibition of Action. Front Psychol. 2020 Jun 10;11:1121. doi: 10.3389/fpsyg.2020.01121. eCollection 2020.

  PMID: 32587547 RESULT

• Le TM, Zhang S, Zhornitsky S, Wang W, Li CR. Neural correlates of reward-directed action and inhibition of action. Cortex. 2020 Feb;123:42-56. doi: 10.1016/j.cortex.2019.10.007. Epub 2019 Oct 31.

  PMID: 31747630 RESULT

MeSH Terms

Conditions

Opioid-Related Disorders; Pain

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thang M Le, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thang M Le, PhD

CONTACT

203-974-7360; thang.le@yale.edu

Chiang-shan R Li, MD, PhD

CONTACT

203-974-7354; chiang-shan.li@yale.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 30, 2025
• Study Start: February 4, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)