Trial Outcomes & Findings for Incentives to Decrease Opioid Use - Pilot (NCT NCT04235582)

Last Updated: 2024-10-03

Results Overview

The primary endpoint is the longest period of continuous abstinence from illicit opioids, where abstinence is measured using lab-verified in-person urine-tests, saliva tests, or subject reporting (in the absence of urine testing).

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

Time = 4 weeks

Results posted on

2024-10-03

Participant Flow

Participant milestones

Participant milestones
Measure	Outcomes Group During the intervention period, the "Outcomes" group will receive incentives for abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care and a similar mobile app and debit card as the Inputs group. However, the app will prompt patients in this group to submit saliva drug tests through their mobile phones on a random schedule (averaging three tests per week). Patients will receive immediate financial rewards in exchange for submitting drug-negative samples. Saliva tests typically have a window of detection between 24-48 hr after drug use.	Inputs Group Will receive incentives for behaviors that are inputs to abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care. Additionally, patients will be registered for a mobile phone app provided by DynamiCare Health and provided with a linked debit card. The app will prompt patients to complete actions that are inputs to abstinence an average of three times per week. These actions will be tailored to the patient's individual needs, and may include: * Drug adherence to prescribed SUD pharmacotherapy * Attendance at individual and group psychotherapy sessions	Combination Group Will receive interventions from both Inputs and Outputs groups, as well as standard of care therapy services and urine drug tests an average of three times per week, total. Interventions include incentives for: * Drug adherence to prescribed SUD pharmacotherapy * Attendance at individual and group psychotherapy sessions * Random saliva tests App + Inputs Contingency Management: The app has programmed contingencies whereby incentives can be earned for behaviors that are inputs to abstaining from drug use (e.g., attending psychotherapy or taking SUD psychopharmacology).
Overall Study STARTED	12	13	11
Overall Study COMPLETED	12	12	8
Overall Study NOT COMPLETED	0	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One participant withdrew and three did not download the app

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inputs Group n=12 Participants Will receive incentives for behaviors that are inputs to abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care. Additionally, patients will be registered for a mobile phone app provided by DynamiCare Health and provided with a linked debit card. The app will prompt patients to complete actions that are inputs to abstinence an average of three times per week. These actions will be tailored to the patient's individual needs, and may include: * Drug adherence to prescribed SUD pharmacotherapy * Attendance at individual and group psychotherapy sessions App + Inputs Contingency Management: The app has programmed contingencies whereby incentives can be earned for behaviors that are inputs to abstaining from drug use (e.g., attending psychotherapy or taking SUD psychopharmacology).	Combination Group n=8 Participants Will receive interventions from both Inputs and Outputs groups, as well as standard of care therapy services and urine drug tests an average of three times per week, total. Interventions include incentives for: * Drug adherence to prescribed SUD pharmacotherapy * Attendance at individual and group psychotherapy sessions * Random saliva tests App + Inputs Contingency Management: The app has programmed contingencies whereby incentives can be earned for behaviors that are inputs to abstaining from drug use (e.g., attending psychotherapy or taking SUD psychopharmacology). App + Outcomes Contingency Management: The app has programmed contingencies whereby incentives can be earned for outcomes of abstaining from drug use (e.g., drug-negative saliva samples on saliva opioid tests).	Total n=32 Participants Total of all reporting groups	Outcomes Group n=12 Participants During the intervention period, the "Outcomes" group will receive incentives for abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care and a similar mobile app and debit card as the Inputs group. However, the app will prompt patients in this group to submit saliva drug tests through their mobile phones on a random schedule (averaging three tests per week). Patients will receive immediate financial rewards in exchange for submitting drug-negative samples. Saliva tests typically have a window of detection between 24-48 hr after drug use. App + Outcomes Contingency Management: The app has programmed contingencies whereby incentives can be earned for outcomes of abstaining from drug use (e.g., drug-negative saliva samples on saliva opioid tests).
Age, Continuous	34.0 years STANDARD_DEVIATION 8.4 • n=7 Participants	29.9 years STANDARD_DEVIATION 8.8 • n=5 Participants	34.6 years STANDARD_DEVIATION 10.1 • n=4 Participants	38.3 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=7 Participants • One participant withdrew and three did not download the app	4 Participants n=5 Participants • One participant withdrew and three did not download the app	10 Participants n=4 Participants • One participant withdrew and three did not download the app	3 Participants n=5 Participants • One participant withdrew and three did not download the app
Sex: Female, Male Male	9 Participants n=7 Participants • One participant withdrew and three did not download the app	4 Participants n=5 Participants • One participant withdrew and three did not download the app	22 Participants n=4 Participants • One participant withdrew and three did not download the app	9 Participants n=5 Participants • One participant withdrew and three did not download the app
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=7 Participants	8 Participants n=5 Participants	26 Participants n=4 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=7 Participants	7 Participants n=5 Participants	28 Participants n=4 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=7 Participants	8 participants n=5 Participants	32 participants n=4 Participants	12 participants n=5 Participants
Employment Full-Time (30+ hr/week)	3 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	2 Participants n=5 Participants
Employment Part-Time (<30 hr/week)	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=5 Participants
Employment Unemployed	8 Participants n=7 Participants	7 Participants n=5 Participants	25 Participants n=4 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Time = 4 weeks

Population: These were any participant who had a saliva test or urine test on file at Week 4.

Outcome measures

Outcome measures
Measure	Outcomes Group n=7 Participants During the intervention period, the "Outcomes" group will receive incentives for abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care and a similar mobile app and debit card as the Inputs group. However, the app will prompt patients in this group to submit saliva drug tests through their mobile phones on a random schedule (averaging three tests per week). Patients will receive immediate financial rewards in exchange for submitting drug-negative samples. Saliva tests typically have a window of detection between 24-48 hr after drug use. App + Outcomes Contingency Management: The app has programmed contingencies whereby incentives can be earned for outcomes of abstaining from drug use (e.g., drug-negative saliva samples on saliva opioid tests).	Inputs Group n=6 Participants Will receive incentives for behaviors that are inputs to abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care. Additionally, patients will be registered for a mobile phone app provided by DynamiCare Health and provided with a linked debit card. The app will prompt patients to complete actions that are inputs to abstinence an average of three times per week. These actions will be tailored to the patient's individual needs, and may include: * Drug adherence to prescribed SUD pharmacotherapy * Attendance at individual and group psychotherapy sessions App + Inputs Contingency Management: The app has programmed contingencies whereby incentives can be earned for behaviors that are inputs to abstaining from drug use (e.g., attending psychotherapy or taking SUD psychopharmacology).	Combination Group n=5 Participants Will receive interventions from both Inputs and Outputs groups, as well as standard of care therapy services and urine drug tests an average of three times per week, total. Interventions include incentives for: * Drug adherence to prescribed SUD pharmacotherapy * Attendance at individual and group psychotherapy sessions * Random saliva tests App + Inputs Contingency Management: The app has programmed contingencies whereby incentives can be earned for behaviors that are inputs to abstaining from drug use (e.g., attending psychotherapy or taking SUD psychopharmacology). App + Outcomes Contingency Management: The app has programmed contingencies whereby incentives can be earned for outcomes of abstaining from drug use (e.g., drug-negative saliva samples on saliva opioid tests).
Continuous Abstinence From Opioid Use	6 Participants	5 Participants	5 Participants

PRIMARY outcome

Timeframe: Time = 8 weeks

Population: These were any participant who had a saliva test or urine test on file at Week 8.

Outcome measures

Outcome measures
Measure	Outcomes Group n=6 Participants During the intervention period, the "Outcomes" group will receive incentives for abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care and a similar mobile app and debit card as the Inputs group. However, the app will prompt patients in this group to submit saliva drug tests through their mobile phones on a random schedule (averaging three tests per week). Patients will receive immediate financial rewards in exchange for submitting drug-negative samples. Saliva tests typically have a window of detection between 24-48 hr after drug use. App + Outcomes Contingency Management: The app has programmed contingencies whereby incentives can be earned for outcomes of abstaining from drug use (e.g., drug-negative saliva samples on saliva opioid tests).	Inputs Group n=6 Participants Will receive incentives for behaviors that are inputs to abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care. Additionally, patients will be registered for a mobile phone app provided by DynamiCare Health and provided with a linked debit card. The app will prompt patients to complete actions that are inputs to abstinence an average of three times per week. These actions will be tailored to the patient's individual needs, and may include: * Drug adherence to prescribed SUD pharmacotherapy * Attendance at individual and group psychotherapy sessions App + Inputs Contingency Management: The app has programmed contingencies whereby incentives can be earned for behaviors that are inputs to abstaining from drug use (e.g., attending psychotherapy or taking SUD psychopharmacology).	Combination Group n=4 Participants Will receive interventions from both Inputs and Outputs groups, as well as standard of care therapy services and urine drug tests an average of three times per week, total. Interventions include incentives for: * Drug adherence to prescribed SUD pharmacotherapy * Attendance at individual and group psychotherapy sessions * Random saliva tests App + Inputs Contingency Management: The app has programmed contingencies whereby incentives can be earned for behaviors that are inputs to abstaining from drug use (e.g., attending psychotherapy or taking SUD psychopharmacology). App + Outcomes Contingency Management: The app has programmed contingencies whereby incentives can be earned for outcomes of abstaining from drug use (e.g., drug-negative saliva samples on saliva opioid tests).
Continuous Abstinence From Opioid Use	6 Participants	5 Participants	3 Participants

PRIMARY outcome

Timeframe: Time = 12 weeks

Population: These were any participant who had a saliva test or urine test on file at Week 12.

The primary endpoint is the % of opioid-negative saliva or urine tests in each group at Week 12

Outcome measures

Outcome measures
Measure	Outcomes Group n=7 Participants During the intervention period, the "Outcomes" group will receive incentives for abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care and a similar mobile app and debit card as the Inputs group. However, the app will prompt patients in this group to submit saliva drug tests through their mobile phones on a random schedule (averaging three tests per week). Patients will receive immediate financial rewards in exchange for submitting drug-negative samples. Saliva tests typically have a window of detection between 24-48 hr after drug use. App + Outcomes Contingency Management: The app has programmed contingencies whereby incentives can be earned for outcomes of abstaining from drug use (e.g., drug-negative saliva samples on saliva opioid tests).	Inputs Group n=8 Participants Will receive incentives for behaviors that are inputs to abstaining from drug use. Patients in this group will receive the same services and urine drug-test schedule as standard of care. Additionally, patients will be registered for a mobile phone app provided by DynamiCare Health and provided with a linked debit card. The app will prompt patients to complete actions that are inputs to abstinence an average of three times per week. These actions will be tailored to the patient's individual needs, and may include: * Drug adherence to prescribed SUD pharmacotherapy * Attendance at individual and group psychotherapy sessions App + Inputs Contingency Management: The app has programmed contingencies whereby incentives can be earned for behaviors that are inputs to abstaining from drug use (e.g., attending psychotherapy or taking SUD psychopharmacology).	Combination Group n=5 Participants Will receive interventions from both Inputs and Outputs groups, as well as standard of care therapy services and urine drug tests an average of three times per week, total. Interventions include incentives for: * Drug adherence to prescribed SUD pharmacotherapy * Attendance at individual and group psychotherapy sessions * Random saliva tests App + Inputs Contingency Management: The app has programmed contingencies whereby incentives can be earned for behaviors that are inputs to abstaining from drug use (e.g., attending psychotherapy or taking SUD psychopharmacology). App + Outcomes Contingency Management: The app has programmed contingencies whereby incentives can be earned for outcomes of abstaining from drug use (e.g., drug-negative saliva samples on saliva opioid tests).
Opioid-negative Saliva Tests at Week 12	6 Participants	5 Participants	3 Participants

Adverse Events

Outcomes Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inputs Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Combination Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mindy Waite, Behavioral Health Research Scientist

Aurora Health Care

Phone: 414-773-4323

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place