Feasibility and Validation of a Standard Phenotyping Assessment Battery

Study Overview
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Brief Summary
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The overall goal of this project is to collect preliminary data on psychosocial measures and behavioral performance comparing individuals with Opioid Use Disorder, Cocaine Use Disorder, dual diagnosis of Opioid and Cocaine Use Disorder, and Healthy Controls in an effort to determine overall feasibility of a phenotypic fingerprint for cohorts of individuals with addictions for use during clinical trials.

Detailed Description
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There is profound heterogeneity of subjects in clinical studies of addictions, with patients being diagnosed by the primary substance of use. As a result, utilizing current DSM addictions classification leads to problems with signal detection and hamper the progress of the development of new drugs and treatments for substance use disorders (SUDs). Getting beyond the DSM-5 based definitions is necessary to fingerprint addiction phenotypes and endophenotypes, using machine-learning analyses of big data. A detailed in-depth assessment of addiction phenotypes (deep phenotyping) may also include neuroimaging. In an effort to develop a fingerprint for addiction phenotypes, NIDA established a Workgroup to develop a phenotyping battery of tests and self-rated psychometric scales, supplemented by resting state fMRI to be administered to participants in any extramural clinical trial where addictions are assessed. The final phenotyping battery content was determined via consensus from both the selected experts- consultants group and the NIDA workgroup, and as such, the battery requires feasibility and validation study to finalize its content. The NIDA Phenotyping Assessment Battery (PhAB) covers six neurofunctional addiction domains: Metacognition, Interoception, Cognition/Executive Function, Reward/Incentive Salience, Emotion/Negative Emotionality, and Sleep/Circadian Rhythm. The PhAB is meant to be administered during a Phenotyping visit - an extension of a screening visit in any clinical trial addictions protocol. In addition to the PhAB, the group also developed an ancillary set of measures to be administered in conjunction with the PhAB in any addictions clinical trial during the Phenotyping visit. The Platform Instruments include structured interviews, diagnostic measures (e.g., MINI), self report scales of symptom severity (e.g., ASRS-ADHD, VAS-Pain), trauma history (CTQ), computer-administered measures of intelligence (e.g., Shipley), and substance use measures (FTND, Timeline Follow-back), etc. Clinical trial investigators would administer these scales and behavioral tasks in addition to protocol nonspecific assessments (e.g., demographics) and medical evaluations (e.g, medical history and physical exams, genotyping, and labs) which could be done at Screening. This study is a feasibility, construct and face validity study. The primary outcome measure is time taken to complete the battery, and rates of successful study completion

Official Title
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NIDA Phenotyping Assessments Battery (PhAB) Feasibility and Validation Study in Non-Intoxicated Drug Users

Conditions
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Opioid-use Disorder, Cocaine Use Disorder, Marijuana Use Disorder, Healthy Controls

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Individuals with SUDs) Males and females between 18 and 70 years-of-age. Current DSM-5 primary Substance Use Disorder: Opioid, marijuana, stimulants (individuals with multiple types of substance use (e.g., opioid/marijuana will be included) Have no contraindications for study participation as determined by medical history and concomitant medications. Be able to demonstrate an understanding of study procedures and follow instructions including behavioral laboratory testing. Be able and willing to comply with scheduled visits, and other study procedures. Be able to read and complete forms and interviews in English. Inclusion Criteria (Non-drug Using Healthy Controls) Males and females between 18 and 70 years of age. Have no contraindications for study participation as determined by medical history and concomitant medications. Be able to demonstrate an understanding of study procedures and follow instructions including behavioral laboratory testing. Be able and willing to comply with scheduled visits, and other study Be able to read and complete forms and interviews in English. General Exclusion Criteria Current psychosis, mania, or suicidal/homicidal ideation Meet current DSM-5 diagnosis of any psychoactive substance use disorder other than opioids,marijuana, stimulants, or nicotine. Diagnosis of mild to moderate use disorder for alcohol will not be considered exclusionary for any SUD group. Have a history of seizures (excluding childhood febrile seizures), or loss of consciousness from traumatic injury for more than 30 minutes. Have any other illness, or condition, which in the opinion of the PI or study physician would preclude safe and/or successful completion of the study. MRI Exclusion Criteria Metal fragments or implants, and/or history of fear of being in closed spaces for MRI scans. Currently pregnant or nursing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals with Cocaine Use Disorder<br>This group will consist of individuals who are determined to have DSM5 diagnosis of Cocaine Use Disorder (n=50). Individuals will be recruited from an existing registry (VCU IRB HMHM20000294, Keyser-Marcus, PI) | |
| Individuals with Opioid Use Disorder<br>This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200). | |
| Individuals with Marijuana Use Disorder<br>This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50). | |
| Healthy Controls<br>This group will consist of individuals who are determined to be non-drug using healthy controls (n=100). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention | Number of dropouts | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Complete Battery | Time to complete the assessment batteries will also be recorded for each task and each participant. | 5 hours | 
| Non-completers of the Battery and Platform Instruments | Number of study completers who did not complete the full battery and platform instruments | 5 hours |