Clinical trial NCT03495869: Feasibility and Validation of a Standard Phenotyping Assessment Battery
Official title: NIDA Phenotyping Assessments Battery (PhAB) Feasibility and Validation Study in Non-Intoxicated Drug Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-use Disorder
Cocaine Use Disorder
Marijuana Use Disorder
Healthy Controls
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-04-12
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Retention
timeFrame: 1 month
Secondary outcomes:
measure: Time to Complete Battery
timeFrame: 5 hours
measure: Non-completers of the Battery and Platform Instruments
timeFrame: 5 hours
Other outcomes:
measure: Performance on Measures of Cognition Across Conditions
timeFrame: 5 hours
measure: Performance on Measures of Reward Processing Across Conditions
timeFrame: 5 hours
measure: Performance on Measures of Negative Emotionality Across Conditions
timeFrame: 5 hours
measure: Self-report on Measure of Interoception Across Conditions
timeFrame: 5 hours
measure: Self-report on Measure of Metacognition Across Conditions
timeFrame: 5 hours
measure: Self-report on Measure of Sleep Quality Across Conditions
timeFrame: 5 hours
measure: Between-group Differences in Brain Connectivity as Measured by Spectral Dynamic Causal Modeling (DCM) and Deterministic Dynamic Causal Modeling
timeFrame: 1 month
Locations:
city: Richmond
country: United States
facility: VCU Institute for Drug and Alcohol Studies
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Lori Keyser-Marcus, PhD
role: PRINCIPAL_INVESTIGATOR
References: