Trial Outcomes & Findings for The Effect of a Contingency Management Intervention on Substance Use (NCT NCT00252512)
NCT ID: NCT00252512
Last Updated: 2018-08-16
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
332 participants
Primary outcome timeframe
8 weeks
Results posted on
2018-08-16
Participant Flow
Two participants withdrew from participation after random assignment to the placebo condition and did not start the intervention.
Participant milestones
| Measure |
Contingency Management
Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value.
|
Placebo
Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
|
|---|---|---|
|
Intervention
STARTED
|
165
|
165
|
|
Intervention
COMPLETED
|
136
|
134
|
|
Intervention
NOT COMPLETED
|
29
|
31
|
|
Six Month Follow up
STARTED
|
136
|
134
|
|
Six Month Follow up
COMPLETED
|
132
|
122
|
|
Six Month Follow up
NOT COMPLETED
|
4
|
12
|
|
12 Month Follow up
STARTED
|
132
|
122
|
|
12 Month Follow up
COMPLETED
|
123
|
121
|
|
12 Month Follow up
NOT COMPLETED
|
9
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of a Contingency Management Intervention on Substance Use
Baseline characteristics by cohort
| Measure |
Contingency Management
n=165 Participants
Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value.
|
Placebo
n=165 Participants
Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
|
Total
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 9.7 • n=99 Participants
|
49.5 years
STANDARD_DEVIATION 8.1 • n=107 Participants
|
49.3 years
STANDARD_DEVIATION 8.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
160 Participants
n=99 Participants
|
163 Participants
n=107 Participants
|
323 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
162 Participants
n=99 Participants
|
158 Participants
n=107 Participants
|
320 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
60 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
90 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
188 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
165 Participants
n=99 Participants
|
165 Participants
n=107 Participants
|
330 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksOutcome measures
| Measure |
Contingency Management
n=165 Participants
Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value.
|
Placebo
n=165 Participants
Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
|
|---|---|---|
|
Number of Negative Breath Alcohol and Urine Drug Screens Out of Possible 16
|
11.93 negative alcohol and drug screens
Standard Deviation 4.67
|
10.39 negative alcohol and drug screens
Standard Deviation 5.18
|
SECONDARY outcome
Timeframe: 8 weeks, 6 months, 12 monthsPopulation: Fewer participants completed 6 and 12 month follow-up assessments than completed 8 week assessment.
Kessler Psychological Distress Scale (K10) - score range 10 to 50. * score under 20 are likely to be well * score 20-24 are likely to have mild psychological distress * score 25-29 are likely to have moderate psychological distress * score 30 and over are likely to have a severe psychological distress
Outcome measures
| Measure |
Contingency Management
n=134 Participants
Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value.
|
Placebo
n=133 Participants
Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
|
|---|---|---|
|
Psychiatric Status
8 week outcomes
|
20.87 units on a scale
Standard Deviation 6.42
|
18.90 units on a scale
Standard Deviation 6.68
|
|
Psychiatric Status
6 month outcomes
|
20.64 units on a scale
Standard Deviation 8.31
|
20.19 units on a scale
Standard Deviation 7.42
|
|
Psychiatric Status
12 month outcomes
|
21.06 units on a scale
Standard Deviation 8.23
|
19.07 units on a scale
Standard Deviation 7.46
|
SECONDARY outcome
Timeframe: Baseline to 6 month follow up and 6 month follow up to 12 month follow up.Cost of total healthcare utilization for six month period between baseline and 6 month follow up and six month period between 6 month and 12 month follow up.
Outcome measures
| Measure |
Contingency Management
n=165 Participants
Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value.
|
Placebo
n=165 Participants
Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
|
|---|---|---|
|
VHA Healthcare Service Utilization
Total VHA healthcare costs: baseline-6 month f/up
|
12744.44 Dollars
Standard Deviation 16321.11
|
16456.32 Dollars
Standard Deviation 28113.13
|
|
VHA Healthcare Service Utilization
Total VHA healthcare costs: 6 month-12 month f/up
|
8934.52 Dollars
Standard Deviation 13467.21
|
8386.94 Dollars
Standard Deviation 13667.40
|
SECONDARY outcome
Timeframe: 8 week, 6 month and 12 month follow-upsPopulation: Fewer participants completed 6 and 12 month follow-up assessments than completed 8 week follow up assessment.
Number of participants reporting stable housing (owned or rented house, apartment or room)
Outcome measures
| Measure |
Contingency Management
n=136 Participants
Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value.
|
Placebo
n=132 Participants
Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
|
|---|---|---|
|
Housing
Housing status at 8 weeks
|
77 Participants
|
66 Participants
|
|
Housing
Housing status at 6 months
|
80 Participants
|
91 Participants
|
|
Housing
Housing at 12 months
|
88 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: 8 weeks, 6 month and 12 month follow upsPopulation: Lower numbers of participants returned for 6 and 12 month follow up assessments compared to 8 week follow up assessment.
Number of participants reporting detention or incarceration in the previous 30 days
Outcome measures
| Measure |
Contingency Management
n=136 Participants
Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value.
|
Placebo
n=134 Participants
Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
|
|---|---|---|
|
Legal Status
Legal status at 8 week follow-up
|
3 Participants
|
2 Participants
|
|
Legal Status
Legal status at 6 month follow-up
|
6 Participants
|
3 Participants
|
|
Legal Status
Legal status at 12 month follow up
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 8 week, 6 month and 12 month follow upPopulation: Fewer participants completed 6 and 12 month follow up assessments compared to 8 week follow up assessment.
Number of participants identifying themselves as unemployed.
Outcome measures
| Measure |
Contingency Management
n=136 Participants
Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value.
|
Placebo
n=134 Participants
Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
|
|---|---|---|
|
Employment Status
Employment status at 8 week follow-up
|
74 Participants
|
57 Participants
|
|
Employment Status
Employment status at 6 month follow-up
|
51 Participants
|
49 Participants
|
|
Employment Status
Employment status at 12 week follow-up
|
32 Participants
|
43 Participants
|
Adverse Events
Contingency Management
Serious events: 49 serious events
Other events: 0 other events
Deaths: 0 deaths
Baseline
Serious events: 53 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Contingency Management
n=165 participants at risk
Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value.
|
Baseline
n=165 participants at risk
Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.
|
|---|---|---|
|
General disorders
Death
|
2.4%
4/165
|
0.61%
1/165
|
|
General disorders
Hospitalization
|
14.5%
24/165 • Number of events 45
|
15.8%
26/165 • Number of events 39
|
|
Psychiatric disorders
Hospitalization
|
16.4%
27/165 • Number of events 41
|
18.2%
30/165 • Number of events 45
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place