Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT03495869
Study type Observational
Source Virginia Commonwealth University
Contact Mandy Adams, MA
Phone 804-828-3686
Status Recruiting
Start date June 21, 2018
Completion date October 2018

See also
  Status Clinical Trial Phase
Recruiting NCT03065049 - Transforming Recovery Through Exercise and Community N/A
Not yet recruiting NCT03595293 - fNIRs-based Neurofeedback to Reduce Relapse in pOUD/AUD N/A
Completed NCT03715634 - Study of a Novel Subcutaneous Depot Formulation of Buprenorphine Phase 1
Not yet recruiting NCT03568552 - Patient Decision Aid for Opioid Use Disorder N/A
Recruiting NCT03766893 - Medication Maintenance Therapy in Community Pharmacy Settings Early Phase 1
Recruiting NCT03279562 - Patient Driven Recovery With Nalmefene and Coaching Phase 2
Not yet recruiting NCT03266445 - Effect of Buprenorphine/Naloxone Continuation on Pain Control and Opioid Use Phase 4
Completed NCT03851731 - Evaluation of Intranasal Naltrexone and Naloxone Phase 1
Recruiting NCT03791645 - Evaluating The Efficacy Of A Mind-Body Intervention In Overcoming Opioid Addiction N/A
Recruiting NCT03365362 - A Trial of Directly Observed and Long-term Varenicline Phase 4
Active, not recruiting NCT03402672 - AWAITS: A Web-based E-health Application for Active Illicit Opioid Users N/A
Enrolling by invitation NCT03411265 - RETAIN: Retaining Opioid Users Entering Medication Assisted Treatment and Encouraging HCV/HIV Testing N/A
Recruiting NCT03740243 - Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology Phase 4
Not yet recruiting NCT03633929 - mHealth for Patient Self-Management of Opioid Use Disorder
Not yet recruiting NCT03699085 - Emergency Department Longitudinal Integrated Care N/A
Recruiting NCT03169816 - Lorcaserin in Combination With XR-Naltrexone for Relapse Prevention in Opioid Use Disorder Phase 2/Phase 3
Not yet recruiting NCT03616379 - Stress Response in Opioid Use Disorder N/A
Not yet recruiting NCT03677986 - Buprenorphine Treatment Engagement and Overdose Prevention N/A
Not yet recruiting NCT03804619 - Accelerated Intermittent Theta-Burst Stimulation for Opiate Use Disorder N/A
Not yet recruiting NCT03773523 - Neuromodulation and Cognitive Training in Opioid Use Disorder N/A