Trial Outcomes & Findings for Feasibility and Validation of a Standard Phenotyping Assessment Battery (NCT NCT03495869)
NCT ID: NCT03495869
Last Updated: 2021-08-04
Results Overview
Number of dropouts
Recruitment status
COMPLETED
Target enrollment
368 participants
Primary outcome timeframe
1 month
Results posted on
2021-08-04
Participant Flow
Participant milestones
| Measure |
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).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
54
|
124
|
61
|
129
|
|
Overall Study
COMPLETED
|
50
|
97
|
51
|
108
|
|
Overall Study
NOT COMPLETED
|
4
|
27
|
10
|
21
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
17
|
8
|
14
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
0
|
3
|
|
Overall Study
Dropped from study
|
0
|
7
|
2
|
4
|
Baseline Characteristics
Feasibility and Validation of a Standard Phenotyping Assessment Battery
Baseline characteristics by cohort
| Measure |
Individuals With Cocaine Use Disorder
n=50 Participants
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
n=97 Participants
This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200).
|
Individuals With Marijuana Use Disorder
n=51 Participants
This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50).
|
Healthy Controls
n=108 Participants
This group will consist of individuals who are determined to be non-drug using healthy controls (n=100).
|
Total
n=306 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.78 years
STANDARD_DEVIATION 8.76 • n=5 Participants
|
42.49 years
STANDARD_DEVIATION 11.57 • n=7 Participants
|
35.24 years
STANDARD_DEVIATION 13.10 • n=5 Participants
|
35.69 years
STANDARD_DEVIATION 14.51 • n=4 Participants
|
40.77 years
STANDARD_DEVIATION 13.82 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
144 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
162 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
280 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
48 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
193 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
1 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or not reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
97 participants
n=7 Participants
|
51 participants
n=5 Participants
|
108 participants
n=4 Participants
|
306 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: All participants who signed consent forms and screened eligible were included in the analysis for this outcome variable.
Number of dropouts
Outcome measures
| Measure |
Individuals With Cocaine Use Disorder
n=54 Participants
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
n=124 Participants
This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200).
|
Individuals With Marijuana Use Disorder
n=61 Participants
This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50).
|
Healthy Controls
n=129 Participants
This group will consist of individuals who are determined to be non-drug using healthy controls (n=100).
|
|---|---|---|---|---|
|
Retention
|
4 Participants
|
27 Participants
|
10 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 5 hoursTime to complete the assessment batteries will also be recorded for each task and each participant.
Outcome measures
| Measure |
Individuals With Cocaine Use Disorder
n=50 Participants
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
n=97 Participants
This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200).
|
Individuals With Marijuana Use Disorder
n=51 Participants
This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50).
|
Healthy Controls
n=108 Participants
This group will consist of individuals who are determined to be non-drug using healthy controls (n=100).
|
|---|---|---|---|---|
|
Time to Complete Battery
Time to complete Phenotyping assessment battery
|
73.86 Minutes
Standard Deviation 15.77
|
68.53 Minutes
Standard Deviation 16.16
|
59.76 Minutes
Standard Deviation 10.19
|
61.04 Minutes
Standard Deviation 17.66
|
|
Time to Complete Battery
Time to complete battery of Platform Instruments
|
96.97 Minutes
Standard Deviation 38.07
|
91.24 Minutes
Standard Deviation 32.83
|
75.08 Minutes
Standard Deviation 28.67
|
68.53 Minutes
Standard Deviation 24.52
|
SECONDARY outcome
Timeframe: 5 hoursNumber of study completers who did not complete the full battery and platform instruments
Outcome measures
| Measure |
Individuals With Cocaine Use Disorder
n=50 Participants
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
n=97 Participants
This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200).
|
Individuals With Marijuana Use Disorder
n=51 Participants
This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50).
|
Healthy Controls
n=108 Participants
This group will consist of individuals who are determined to be non-drug using healthy controls (n=100).
|
|---|---|---|---|---|
|
Non-completers of the Battery and Platform Instruments
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 hoursPerformance (time to complete) #correct) on behavioral tasks which examine cognitive functioning (e.g., Backwards digit span, and stop signal reaction task)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 hoursPerformance (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)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 hoursPerformance (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)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 hoursPerformance (time to complete)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 hoursPerformance (time to complete)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 hoursPerformance (time to complete)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 monthBetween-group differences in brain connectivity as measured by Spectral dynamic causal modeling (DCM) and Deterministic dynamic causal modeling
Outcome measures
Outcome data not reported
Adverse Events
Individuals With Cocaine Use Disorder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Individuals With Opioid Use Disorder
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Individuals With Marijuana Use Disorder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Individuals With Cocaine Use Disorder
n=50 participants at risk
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
n=97 participants at risk
This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200).
|
Individuals With Marijuana Use Disorder
n=51 participants at risk
This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50).
|
Healthy Controls
n=108 participants at risk
This group will consist of individuals who are determined to be non-drug using healthy controls (n=100).
|
|---|---|---|---|---|
|
Infections and infestations
hospitalization
|
0.00%
0/50 • 1 month
AE form/log
|
1.0%
1/97 • Number of events 1 • 1 month
AE form/log
|
0.00%
0/51 • 1 month
AE form/log
|
0.00%
0/108 • 1 month
AE form/log
|
Other adverse events
Adverse event data not reported
Additional Information
Lori Keyser-Marcus, PhD
Virginia Commonwealth University
Phone: (804) 828-4164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place