Feasibility and Validation of a Standard Phenotyping Assessment Battery

NCT ID: NCT03495869

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 368 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-21
• Study Completion Date: 2020-03-16

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

Conditions

Opioid-use Disorder; Cocaine Use Disorder; Marijuana Use Disorder; Healthy Controls

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

Individuals with Opioid Use Disorder

This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200).

No interventions assigned to this group

Individuals with Marijuana Use Disorder

This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50).

No interventions assigned to this group

Healthy Controls

This group will consist of individuals who are determined to be non-drug using healthy controls (n=100).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

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.

• Metal fragments or implants, and/or history of fear of being in closed spaces for MRI scans.
• Currently pregnant or nursing.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lori Keyser-Marcus, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

VCU Institute for Drug and Alcohol Studies

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U54DA038999

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20012559

Identifier Type: -

Identifier Source: org_study_id