Feasibility and Validation of a Standard Phenotyping Assessment Battery

Completed

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

• Registration Number: NCT03495869
• Lead Sponsor: Virginia Commonwealth University

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-29
• Study First Submitted QC: 2018-04-10
• Study First Posted: 2018-04-12
• Study Start: 2018-06-21
• Primary Completion: 2020-03-16
• Study Completion: 2020-03-16
• Status Verified: 2021-07
• Results First Submitted: 2021-07-13
• Results First Submitted QC: 2021-07-13
• Last Update Submitted: 2021-07-13
• Results First Posted: 2021-08-04
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 368

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retention	1 month	Number of dropouts

Secondary Outcome Measures

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

Trial Locations

Locations (1)

VCU Institute for Drug and Alcohol Studies; 🇺🇸 Richmond, Virginia, United States