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Trial record 17 of 1786 for:    NIDA

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 : June 27, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
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.

Condition or disease
Opioid-use Disorder Cocaine Use Disorder

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
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: NIDA Phenotyping Assessments Battery (PhAB) Feasibility and Validation Study in Non-Intoxicated Drug Users
Actual Study Start Date : June 21, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Group/Cohort
Individuals with Cocaine Use Disorder

This group will consist of individuals who are determined to have DSM5 diagnosis of Cocaine Use Disorder. The enrollment number is 2:1 over the targeted sample size (N=90, n=10 in this cohort), in order to account for screen fails and individuals who fail to continue the study due to lack of interest, loss to follow-up, etc.

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. The enrollment number is 2:1 over the targeted sample size (N=90, n=10 in this cohort), in order to account for screen fails and individuals who fail to continue the study due to lack of interest, loss to follow-up, etc.
Individuals with Cocaine and Opioid Use Disorder
This group will consist of individuals who are determined to have DSM5 diagnosis of Cocaine and Opioid Use Disorder. The enrollment number is 2:1 over the targeted sample size (N=90, n=10 in this cohort), in order to account for screen fails and individuals who fail to continue the study due to lack of interest, loss to follow-up, etc.
Healthy Controls
This group will consist of individuals who are determined to be non-drug using healthy controls. The enrollment number is 2:1 over the targeted sample size (N=90, n=60 in this cohort), in order to account for screen fails and individuals who fail to continue the study due to lack of interest, loss to follow-up, etc.



Primary Outcome Measures :
  1. Retention [ Time Frame: 6 months ]
    Percentage of dropouts


Secondary Outcome Measures :
  1. Time to complete battery [ Time Frame: 6 months ]
    Time to complete the assessment batteries will also be recorded for each task and each participant.

  2. Non-completers of the Battery and Platform Instruments [ Time Frame: 6 months ]
    Percentage of noncompleters



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study utilizes a four-group cross sectional cohort design. A total of 90 participants (across 4 cohorts) are targeted to complete the study) to include: Healthy Controls (n=60), individuals with CocUD (n=10), individuals with OUD (n=10), and individuals with CocUD and OUD (n=10).
Criteria

Inclusion Criteria:

  1. Males and females between 18 and 70 years-of-age.
  2. Understand the study procedures and ability to provide written informed consent.
  3. Meet current DSM-5 criteria for opioid use disorder, cocaine use disorder, or opioid and cocaine use disorder.
  4. Have no contraindications for study participation as determined by medical history and concomitant medications.
  5. Be able to demonstrate an understanding of study procedures and follow instructions including behavioral laboratory testing.
  6. Pregnancy is not an exclusion for this study as there are no interventions in the study that would affect the fetus. Women found to be pregnant during the study will be referred to the VCU OB clinic.
  7. Be able and willing to comply with scheduled visits, and other study procedures.
  8. Be able to read and complete forms and interviews in English.

Exclusion Criteria:

In order to participate in the study, subjects must not:

  1. Meet current DSM-5 diagnosis of any psychoactive substance use disorder other than opioids, marijuana, cocaine, or nicotine. Diagnosis of mild to moderate use disorder for alcohol and/or marijuana will not be considered exclusionary.
  2. Have a current DSM-5 axis I major psychiatric disorder other than substance use disorder including but not limited to Bipolar Disorder, or Schizophrenia or a neurological disorder requiring ongoing treatment and/or making study participation unsafe.
  3. Have any clinically significant medical disorder that the investigator considers would be affect study battery completion including but not limited by cardiovascular, pulmonary, CNS, hepatic, or renal disorder.
  4. Have a history of seizures (excluding childhood febrile seizures), or loss of consciousness from traumatic injury for more than 30 minutes.
  5. Have significant current suicidal or homicidal ideation.
  6. Have a positive HIV test by self-report or history.
  7. Have any other illness, or condition, which in the opinion of the PI would preclude safe and/or successful completion of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495869


Contacts
Contact: Mandy Adams, MA 804-828-3686 msadams@vcu.edu

Locations
United States, Virginia
VCU Institute for Drug and Alcohol Studies Recruiting
Richmond, Virginia, United States, 23219
Contact: Mandy Adams    804-828-3686    study4u@vcu.edu   
Sponsors and Collaborators
Virginia Commonwealth University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Lori Keyser-Marcus, PhD Virginia Commonwealth University

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03495869     History of Changes
Other Study ID Numbers: HM20012559
U54DA038999 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Pathologic Processes
Analgesics, Opioid
Cocaine
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents