Opioid Use Disorder and Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-60
SponsorYale University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Between ages 21-60 years old.
Able to read and write and provide written informed consent.
Meet DSM-5 criteria for moderate to severe opioid use disorder; self-reported excessive opioid use prior to study entry and verified by urine toxicology testing; seeking treatment for their OUD.
Physically healthy with no major medical illnesses, history of head injury or any neurological illness
Disqualifiers
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).
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
follow up interviews for 12 months to determine opioid use
BehavioralFollow-up
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: opioid use disorder1 intervention
Group B: Healthy controls0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Day 1 (immediately after consent and clinical assessment)2
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
Time frame
During the 12-month follow-up period3
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.
Time frame
Day 1 (immediately after consent and clinical assessment)Secondary outcomes
1
Comparison of avoidance learning rate between women and men
Sex differences in avoidance learning dysfunction in those with opioid use disorder. Comparison between women and men will be conducted in relation to their avoidance learning task performance (e.g., performance accuracy, response time)
Time frame
Day 1 (immediately after consent and clinical assessment)2
Comparison of brain activity during avoidance learning between women and men
Comparison between women and men will be conducted in relation to their brain activations during avoidance learning to determine whether women or men may have higher brain activity amplitude during learning of avoidance behavior.
Time frame
Day 1 (immediately after consent and clinical assessment)3
Relationship between sex differences in avoidance learning and opioid use
Investigators will examine whether opioid use severity has a relationship with differences in avoidance learning performance.
Time frame
Day 1 (immediately after consent and clinical assessment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov