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| ID | Type | Description | Link |
|---|---|---|---|
| U54DA038999 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| Retention | Number of dropouts | 1 month |
| 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 |
| 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 |
Inclusion Criteria (Individuals with SUDs)
Inclusion Criteria (Non-drug Using Healthy Controls)
General Exclusion Criteria
MRI Exclusion Criteria
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Lori Keyser-Marcus, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VCU Institute for Drug and Alcohol Studies | Richmond | Virginia | 23219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | Individuals With Opioid Use Disorder | This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200). |
| FG002 | Individuals With Marijuana Use Disorder | This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50). |
| FG003 | Healthy Controls | This group will consist of individuals who are determined to be non-drug using healthy controls (n=100). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | Individuals With Opioid Use Disorder |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retention | Number of dropouts | All participants who signed consent forms and screened eligible were included in the analysis for this outcome variable. | Posted | Count of Participants | Participants | 1 month |
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1 month
AE form/log
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization | Infections and infestations | Systematic Assessment | Participant was hospitalized to treat cellulitis of a vein that occurred as a result of plasma donation the day prior to study enrollment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lori Keyser-Marcus, PhD | Virginia Commonwealth University | (804) 828-4164 | lori.keysermarcus@vcuhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2019 | Jul 13, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 22, 2019 | Jan 22, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 5 hours |
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 |
| Withdrawal by Subject |
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| Dropped from study |
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This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200). |
| BG002 | Individuals With Marijuana Use Disorder | This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50). |
| BG003 | Healthy Controls | This group will consist of individuals who are determined to be non-drug using healthy controls (n=100). |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG002 | Individuals With Marijuana Use Disorder | This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50). |
| OG003 | Healthy Controls | This group will consist of individuals who are determined to be non-drug using healthy controls (n=100). |
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| Secondary | Time to Complete Battery | Time to complete the assessment batteries will also be recorded for each task and each participant. | Posted | Mean | Standard Deviation | Minutes | 5 hours |
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| Secondary | Non-completers of the Battery and Platform Instruments | Number of study completers who did not complete the full battery and platform instruments | Posted | Number | participants | 5 hours |
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| Other Pre-specified | 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) | Not Posted | 5 hours | Participants |
| Other Pre-specified | 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) | Not Posted | 5 hours | Participants |
| Other Pre-specified | 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) | Not Posted | 5 hours | Participants |
| Other Pre-specified | Self-report on Measure of Interoception Across Conditions | Performance (time to complete) | Not Posted | 5 hours | Participants |
| Other Pre-specified | Self-report on Measure of Metacognition Across Conditions | Performance (time to complete) | Not Posted | 5 hours | Participants |
| Other Pre-specified | Self-report on Measure of Sleep Quality Across Conditions | Performance (time to complete) | Not Posted | 5 hours | Participants |
| Other Pre-specified | 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 | Not Posted | 1 month | Participants |
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Individuals With Opioid Use Disorder | This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200). | 0 | 97 | 1 | 97 | 0 | 97 |
| EG002 | Individuals With Marijuana Use Disorder | This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50). | 0 | 51 | 0 | 51 | 0 | 51 |
| EG003 | Healthy Controls | This group will consist of individuals who are determined to be non-drug using healthy controls (n=100). | 0 | 108 | 0 | 108 | 0 | 108 |
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| Time to complete battery of Platform Instruments |
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