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

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ClinicalTrials.gov Identifier: NCT03495869
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date March 29, 2018
First Posted Date April 12, 2018
Last Update Posted Date September 11, 2019
Actual Study Start Date June 21, 2018
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 1, 2019)
Retention [ Time Frame: 12 months ]
Percentage of dropouts
Original Primary Outcome Measures
 (submitted: April 10, 2018)
Retention [ Time Frame: 6 months ]
Percentage of dropouts
Change History Complete list of historical versions of study NCT03495869 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 1, 2019)
  • Time to complete battery [ Time Frame: 12 months ]
    Time to complete the assessment batteries will also be recorded for each task and each participant.
  • Non-completers of the Battery and Platform Instruments [ Time Frame: 12 months ]
    Percentage of noncompleters
  • Performance on measures of Cognition across conditions [ Time Frame: 12 months ]
    Performance (time to complete, #errors, #correct) on behavioral tasks which examine cognitive functioning (e.g., Backwards digit span, and stop signal reaction task)
  • Performance on measures of Reward Processing across conditions [ Time Frame: 12 months ]
    Performance (time to complete, #errors, #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)
  • Performance on measures of Negative Emotionality across conditions [ Time Frame: 12 months ]
    Performance (time to complete, #errors, #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)
  • Self-report on measure of Interoception across conditions [ Time Frame: 12 months ]
    Subscale and total scale scores on self-report measure of Interoception
  • Self-report on measure of Metacognition across conditions [ Time Frame: 12 months ]
    Subscale and total scale scores on self-report measure of Metacognition
  • Self-report on measure of Sleep Quality across conditions [ Time Frame: 12 months ]
    Subscale and total scale scores on self-report measure of Sleep Quality
  • Between-group differences in brain connectivity as measured by Spectral dynamic causal modeling (DCM) and Deterministic dynamic causal modeling [ Time Frame: 12 months ]
    Between-group differences in brain connectivity as measured by Spectral dynamic causal modeling (DCM) and Deterministic dynamic causal modeling
Original Secondary Outcome Measures
 (submitted: April 10, 2018)
  • Time to complete battery [ Time Frame: 6 months ]
    Time to complete the assessment batteries will also be recorded for each task and each participant.
  • Non-completers of the Battery and Platform Instruments [ Time Frame: 6 months ]
    Percentage of noncompleters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition
  • Opioid-use Disorder
  • Cocaine Use Disorder
  • Marijuana Use Disorder
  • Healthy Controls
Intervention Not Provided
Study Groups/Cohorts
  • 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 1, 2019)
400
Original Estimated Enrollment
 (submitted: April 10, 2018)
180
Estimated Study Completion Date August 31, 2020
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Mandy Adams, MA 804-828-3686 msadams@vcu.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03495869
Other Study ID Numbers HM20012559
U54DA038999 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Virginia Commonwealth University
Study Sponsor Virginia Commonwealth University
Collaborators National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Lori Keyser-Marcus, PhD Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date September 2019