N/A
N=368
Feasibility and Validation of a Standard Phenotyping Assessment Battery
Opioid-use Disorder · Cocaine Use Disorder · Marijuana Use Disorder · Healthy Controls
Bottom Line
View on ClinicalTrials.gov: NCT03495869 ↗Enrolled (actual)
368
Serious AEs
0.3%
Results posted
Aug 2021
Primary outcome: Primary: Retention — 4; 27; 10; 21 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention |
4; 27; 10; 21 | — |
| SECONDARY Time to Complete Battery |
73.86; 68.53; 59.76; 61.04; 96.97; 91.24 | — |
| SECONDARY Non-completers of the Battery and Platform Instruments |
0; 0; 0; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03495869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.