Cocaine Use Disorder, Healthy Controls, Marijuana Use Disorder, Opioid-use Disorder
Conditions
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
Interventions
None listed
Sponsors
National Institute on Drug Abuse (NIDA)
Virginia Commonwealth University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention | 1 month | Number of dropouts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Complete Battery | 5 hours | Time to complete the assessment batteries will also be recorded for each task and each participant. |
| Non-completers of the Battery and Platform Instruments | 5 hours | Number of study completers who did not complete the full battery and platform instruments |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-report on Measure of Interoception Across Conditions | 5 hours | Performance (time to complete) |
| Self-report on Measure of Metacognition Across Conditions | 5 hours | Performance (time to complete) |
| Performance on Measures of Cognition Across Conditions | 5 hours | Performance (time to complete) #correct) on behavioral tasks which examine cognitive functioning (e.g., Backwards digit span, and stop signal reaction task) |
| Between-group Differences in Brain Connectivity as Measured by Spectral Dynamic Causal Modeling (DCM) and Deterministic Dynamic Causal Modeling | 1 month | Between-group differences in brain connectivity as measured by Spectral dynamic causal modeling (DCM) and Deterministic dynamic causal modeling |
| Self-report on Measure of Sleep Quality Across Conditions | 5 hours | Performance (time to complete) |
| Performance on Measures of Reward Processing Across Conditions | 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) |
| Performance on Measures of Negative Emotionality Across Conditions | 5 hours | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 50 |
| Individuals With Opioid Use Disorder This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200). | 97 |
| Individuals With Marijuana Use Disorder This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50). | 51 |
| Healthy Controls This group will consist of individuals who are determined to be non-drug using healthy controls (n=100). | 108 |
| Total | 306 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Dropped from study | 0 | 7 | 2 | 4 |
| Overall Study | Lost to Follow-up | 4 | 17 | 8 | 14 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 0 | 3 |
Baseline characteristics
| Characteristic | Individuals With Cocaine Use Disorder | Total | Healthy Controls | Individuals With Marijuana Use Disorder | Individuals With Opioid Use Disorder |
|---|---|---|---|---|---|
| Age, Continuous | 51.78 years STANDARD_DEVIATION 8.76 | 40.77 years STANDARD_DEVIATION 13.82 | 35.69 years STANDARD_DEVIATION 14.51 | 35.24 years STANDARD_DEVIATION 13.1 | 42.49 years STANDARD_DEVIATION 11.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 7 Participants | 3 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 280 Participants | 99 Participants | 46 Participants | 91 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 19 Participants | 6 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 5 Participants | 4 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 10 Participants | 8 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Black or African American | 48 Participants | 193 Participants | 42 Participants | 31 Participants | 72 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants | 8 Participants | 6 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Unknown or not reported | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 1 Participants | 88 Participants | 47 Participants | 17 Participants | 23 Participants |
| Region of Enrollment United States | 50 participants | 306 participants | 108 participants | 51 participants | 97 participants |
| Sex: Female, Male Female | 13 Participants | 144 Participants | 64 Participants | 22 Participants | 45 Participants |
| Sex: Female, Male Male | 37 Participants | 162 Participants | 44 Participants | 29 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 97 | 0 / 51 | 0 / 108 |
| other Total, other adverse events | 0 / 50 | 0 / 97 | 0 / 51 | 0 / 108 |
| serious Total, serious adverse events | 0 / 50 | 1 / 97 | 0 / 51 | 0 / 108 |
Outcome results
Primary
Retention
Number of dropouts
Time frame: 1 month
Population: All participants who signed consent forms and screened eligible were included in the analysis for this outcome variable.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individuals With Cocaine Use Disorder | Retention | 4 Participants |
| Individuals With Opioid Use Disorder | Retention | 27 Participants |
| Individuals With Marijuana Use Disorder | Retention | 10 Participants |
| Healthy Controls | Retention | 21 Participants |
Secondary
Non-completers of the Battery and Platform Instruments
Number of study completers who did not complete the full battery and platform instruments
Time frame: 5 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Individuals With Cocaine Use Disorder | Non-completers of the Battery and Platform Instruments | 0 participants |
| Individuals With Opioid Use Disorder | Non-completers of the Battery and Platform Instruments | 0 participants |
| Individuals With Marijuana Use Disorder | Non-completers of the Battery and Platform Instruments | 0 participants |
| Healthy Controls | Non-completers of the Battery and Platform Instruments | 0 participants |
Secondary
Time to Complete Battery
Time to complete the assessment batteries will also be recorded for each task and each participant.
Time frame: 5 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individuals With Cocaine Use Disorder | Time to Complete Battery | Time to complete Phenotyping assessment battery | 73.86 Minutes | Standard Deviation 15.77 |
| Individuals With Cocaine Use Disorder | Time to Complete Battery | Time to complete battery of Platform Instruments | 96.97 Minutes | Standard Deviation 38.07 |
| Individuals With Opioid Use Disorder | Time to Complete Battery | Time to complete battery of Platform Instruments | 91.24 Minutes | Standard Deviation 32.83 |
| Individuals With Opioid Use Disorder | Time to Complete Battery | Time to complete Phenotyping assessment battery | 68.53 Minutes | Standard Deviation 16.16 |
| Individuals With Marijuana Use Disorder | Time to Complete Battery | Time to complete battery of Platform Instruments | 75.08 Minutes | Standard Deviation 28.67 |
| Individuals With Marijuana Use Disorder | Time to Complete Battery | Time to complete Phenotyping assessment battery | 59.76 Minutes | Standard Deviation 10.19 |
| Healthy Controls | Time to Complete Battery | Time to complete Phenotyping assessment battery | 61.04 Minutes | Standard Deviation 17.66 |
| Healthy Controls | Time to Complete Battery | Time to complete battery of Platform Instruments | 68.53 Minutes | Standard Deviation 24.52 |
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
Time frame: 1 month
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)
Time frame: 5 hours
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)
Time frame: 5 hours
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)
Time frame: 5 hours
Other Pre-specified
Self-report on Measure of Interoception Across Conditions
Performance (time to complete)
Time frame: 5 hours
Other Pre-specified
Self-report on Measure of Metacognition Across Conditions
Performance (time to complete)
Time frame: 5 hours
Other Pre-specified
Self-report on Measure of Sleep Quality Across Conditions
Performance (time to complete)
Time frame: 5 hours