Trial Outcomes & Findings for Extending Long-term Outcomes Through an Adaptive Aftercare Intervention (NCT NCT02143063)
NCT ID: NCT02143063
Last Updated: 2022-01-13
Results Overview
Longest duration of consecutive cocaine-negative urine toxicology tests
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
274 participants
Primary outcome timeframe
baseline through 6 months
Results posted on
2022-01-13
Participant Flow
Participant milestones
| Measure |
Standard Care (SC)
Standard care IOP treatment for cocaine use disorder. In addition, SC participants submitted urine samples during the 24-week intervention phase. Patients selected two days a week on which drug screens might occur (e.g., M/Th, T/F). On the morning of each potential drug screen day, research staff texted participants to indicate if a sample was due. In weeks 1-3, urine screens occurred on two days per week. In weeks 4-9, screens occurred on one randomly selected day each week. In weeks 10-24, drug screens occurred once every 2-3 weeks on average. After a missed sample, the next two screen days were prompted for sample submission. An algorithm developed in-house was used to generate and monitor the drug screen schedule. Participants received $2 per requested sample submitted plus a $20 bonus for submitting all requested samples in a 4-week period. The goal was to result in 18 samples on average, equivalent relative to the new SC plus variable interval CM condition.
|
Standard Care Plus Traditional Contingency Management
Standard care plus "standard" prize contingency management twice weekly for urine screens indicating cocaine abstinence. Urine screens occurred on the same monitoring schedule described for the SC condition, including $2 per requested sample submitted and a $20 bonus for all requested samples in a 4-week period. In addition, participants received chances for prizes on a escalating reinforcement schedule and with a reset condition for unexcused missed samples. Mean maximum earnings for cocaine-negative urine screens was $460 in prizes.
|
Standard Care Plus Variable Interval Contingency Management
Standard care plus prize contingency management on a variable interval schedule for cocaine abstinence. Relative to the traditional CM condition, in this condition, the frequency of samples to earn reinforcement decreased over time contingent on achieving periods of sustained abstinence. The schedule was designed to result in an average of at least 18 urine samples over 24 weeks among participants maintaining abstinence. Participants received the sample compensation for submitted urine samples regardless of results as in the other two conditions.
|
|---|---|---|---|
|
Overall Study
STARTED
|
61
|
105
|
108
|
|
Overall Study
COMPLETED
|
45
|
75
|
78
|
|
Overall Study
NOT COMPLETED
|
16
|
30
|
30
|
Reasons for withdrawal
| Measure |
Standard Care (SC)
Standard care IOP treatment for cocaine use disorder. In addition, SC participants submitted urine samples during the 24-week intervention phase. Patients selected two days a week on which drug screens might occur (e.g., M/Th, T/F). On the morning of each potential drug screen day, research staff texted participants to indicate if a sample was due. In weeks 1-3, urine screens occurred on two days per week. In weeks 4-9, screens occurred on one randomly selected day each week. In weeks 10-24, drug screens occurred once every 2-3 weeks on average. After a missed sample, the next two screen days were prompted for sample submission. An algorithm developed in-house was used to generate and monitor the drug screen schedule. Participants received $2 per requested sample submitted plus a $20 bonus for submitting all requested samples in a 4-week period. The goal was to result in 18 samples on average, equivalent relative to the new SC plus variable interval CM condition.
|
Standard Care Plus Traditional Contingency Management
Standard care plus "standard" prize contingency management twice weekly for urine screens indicating cocaine abstinence. Urine screens occurred on the same monitoring schedule described for the SC condition, including $2 per requested sample submitted and a $20 bonus for all requested samples in a 4-week period. In addition, participants received chances for prizes on a escalating reinforcement schedule and with a reset condition for unexcused missed samples. Mean maximum earnings for cocaine-negative urine screens was $460 in prizes.
|
Standard Care Plus Variable Interval Contingency Management
Standard care plus prize contingency management on a variable interval schedule for cocaine abstinence. Relative to the traditional CM condition, in this condition, the frequency of samples to earn reinforcement decreased over time contingent on achieving periods of sustained abstinence. The schedule was designed to result in an average of at least 18 urine samples over 24 weeks among participants maintaining abstinence. Participants received the sample compensation for submitted urine samples regardless of results as in the other two conditions.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
28
|
29
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
1
|
Baseline Characteristics
Extending Long-term Outcomes Through an Adaptive Aftercare Intervention
Baseline characteristics by cohort
| Measure |
Standard Care
n=61 Participants
standard care
standard care
|
Standard Care Plus Traditional Contingency Managment
n=105 Participants
prize contingency management on a traditional twice weekly schedule for cocaine abstinence
prize contingency management on a traditional twice weekly schedule for cocaine abstinence
standard care
|
Standard Care Plus Variable Interval Contingency Management
n=108 Participants
prize contingency management on a variable interval schedule for cocaine abstinence
prize contingency management on a variable interval schedule for cocaine abstinence
standard care
|
Total
n=274 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.9 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
39.7 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
40.1 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
147 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
127 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
209 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
105 participants
n=7 Participants
|
108 participants
n=5 Participants
|
274 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline through 6 monthsLongest duration of consecutive cocaine-negative urine toxicology tests
Outcome measures
| Measure |
Standard Care Plus Traditional Contingency Managment
n=104 Participants
prize contingency management on a traditional twice weekly schedule for cocaine abstinence
prize contingency management on a traditional twice weekly schedule for cocaine abstinence
standard care
|
Standard Care Plus Variable Interval Contingency Management
n=104 Participants
prize contingency management on a variable interval schedule for cocaine abstinence
prize contingency management on a variable interval schedule for cocaine abstinence
standard care
|
Standard Care
n=58 Participants
standard care
standard care
|
|---|---|---|---|
|
Longest Duration of Abstinence From Cocaine
|
6.64 weeks
Interval 2.79 to 13.57
|
6.93 weeks
Interval 2.14 to 12.57
|
4.14 weeks
Interval 1.14 to 8.86
|
SECONDARY outcome
Timeframe: baseline through 6 monthsBased on breath and urine toxicology tests (alcohol, methamphetamine, cocaine, opioids, THC, amphetamine, benzodiazepines)
Outcome measures
| Measure |
Standard Care Plus Traditional Contingency Managment
n=104 Participants
prize contingency management on a traditional twice weekly schedule for cocaine abstinence
prize contingency management on a traditional twice weekly schedule for cocaine abstinence
standard care
|
Standard Care Plus Variable Interval Contingency Management
n=104 Participants
prize contingency management on a variable interval schedule for cocaine abstinence
prize contingency management on a variable interval schedule for cocaine abstinence
standard care
|
Standard Care
n=58 Participants
standard care
standard care
|
|---|---|---|---|
|
Longest Duration of Abstinence From All Substances Tested
|
5.93 weeks
Interval 1.57 to 12.64
|
5.71 weeks
Interval 1.57 to 11.64
|
4.75 weeks
Interval 0.68 to 8.04
|
Adverse Events
Standard Care
Serious events: 46 serious events
Other events: 12 other events
Deaths: 0 deaths
Standard Care Plus Traditional Contingency Managment
Serious events: 66 serious events
Other events: 7 other events
Deaths: 1 deaths
Standard Care Plus Variable Interval Contingency Management
Serious events: 77 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Standard Care
n=61 participants at risk
standard care
standard care
|
Standard Care Plus Traditional Contingency Managment
n=105 participants at risk
prize contingency management on a traditional twice weekly schedule for cocaine abstinence
prize contingency management on a traditional twice weekly schedule for cocaine abstinence
standard care
|
Standard Care Plus Variable Interval Contingency Management
n=108 participants at risk
prize contingency management on a variable interval schedule for cocaine abstinence
prize contingency management on a variable interval schedule for cocaine abstinence
standard care
|
|---|---|---|---|
|
Social circumstances
Inpatient substance use treatment
|
44.3%
27/61 • Number of events 58 • 18 months
|
38.1%
40/105 • Number of events 59 • 18 months
|
43.5%
47/108 • Number of events 66 • 18 months
|
|
Psychiatric disorders
Inpatient psychiatric treatment
|
14.8%
9/61 • Number of events 18 • 18 months
|
4.8%
5/105 • Number of events 7 • 18 months
|
11.1%
12/108 • Number of events 16 • 18 months
|
|
General disorders
Inpatient medical treatment
|
19.7%
12/61 • Number of events 19 • 18 months
|
19.0%
20/105 • Number of events 28 • 18 months
|
16.7%
18/108 • Number of events 25 • 18 months
|
|
General disorders
Death
|
0.00%
0/61 • 18 months
|
0.95%
1/105 • Number of events 1 • 18 months
|
0.93%
1/108 • Number of events 1 • 18 months
|
Other adverse events
| Measure |
Standard Care
n=61 participants at risk
standard care
standard care
|
Standard Care Plus Traditional Contingency Managment
n=105 participants at risk
prize contingency management on a traditional twice weekly schedule for cocaine abstinence
prize contingency management on a traditional twice weekly schedule for cocaine abstinence
standard care
|
Standard Care Plus Variable Interval Contingency Management
n=108 participants at risk
prize contingency management on a variable interval schedule for cocaine abstinence
prize contingency management on a variable interval schedule for cocaine abstinence
standard care
|
|---|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
14.8%
9/61 • Number of events 11 • 18 months
|
3.8%
4/105 • Number of events 5 • 18 months
|
5.6%
6/108 • Number of events 6 • 18 months
|
|
General disorders
ER visit for overdose
|
4.9%
3/61 • Number of events 3 • 18 months
|
2.9%
3/105 • Number of events 5 • 18 months
|
2.8%
3/108 • Number of events 3 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place