Feasibility and Validation of a Standard Phenotyping Assessment Battery (PhAB)

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

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.

Study Overview

• Status: Completed
• Conditions: Opioid-use Disorder; Cocaine Use Disorder; Healthy Controls; Marijuana Use Disorder

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 368

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23219
      • VCU Institute for Drug and Alcohol Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study utilizes a four-group cross sectional cohort design. A total of 400 participants (across 4 cohorts) are targeted to complete the study) to include: Healthy Controls (n=100), individuals with CocUD (n=50), individuals with OUD (n=200), and individuals with MJUD (n=50).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Individuals with Cocaine Use Disorder; 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; This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200).
Individuals with Marijuana Use Disorder; This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50).
Healthy Controls; This group will consist of individuals who are determined to be non-drug using healthy controls (n=100).

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance on Measures of Cognition Across Conditions	Performance (time to complete) #correct) on behavioral tasks which examine cognitive functioning (e.g., Backwards digit span, and stop signal reaction task)	5 hours
Performance on Measures of Reward Processing Across Conditions	Performance (time to complete) #correct) on behavioral tasks which examine Reward processing (e.g., hypothetical purchase task) and subscale and total scale scores on self-report measures of reward processing (SUPP-S)	5 hours
Performance on Measures of Negative Emotionality Across Conditions	Performance (time to complete) #correct) on behavioral tasks which examine Negative Emotionality (Emotional go/nogo) and subscale and total scale scores on self-report measures of Negative Emotionality (Buss Perry Aggression)	5 hours
Self-report on Measure of Interoception Across Conditions	Performance (time to complete)	5 hours
Self-report on Measure of Metacognition Across Conditions	Performance (time to complete)	5 hours
Self-report on Measure of Sleep Quality Across Conditions	Performance (time to complete)	5 hours
Between-group Differences in Brain Connectivity as Measured by Spectral Dynamic Causal Modeling (DCM) and Deterministic Dynamic Causal Modeling	Between-group differences in brain connectivity as measured by Spectral dynamic causal modeling (DCM) and Deterministic dynamic causal modeling	1 month

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Lori Keyser-Marcus, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2018
• Primary Completion (Actual): March 16, 2020
• Study Completion (Actual): March 16, 2020

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Narcotic-Related Disorders; Disease; Opioid-Related Disorders; Marijuana Use
• Other Study ID Numbers: HM20012559; U54DA038999 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No