Trial Outcomes & Findings for Collaborative Care for Opioid Dependence And Pain Pilot Study (NCT NCT04121546)

NCT ID: NCT04121546

Last Updated: 2024-03-01

Results Overview

Percentage change in daily opioid morphine milligram equivalent (MME) dose

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2024-03-01

Participant Flow

Participant milestones

Measure	Intervention Arm Patients will receive the telecare intervention. Telecare Intervention: Patients will meet with a care coordinator to discuss current opioid use pattern and potential reduction strategies. Participants will fill out baseline measures. A 6 week positive psychology intervention will also be introduced in which patients will practice different techniques each week over 6 weeks, and will then practice incorporating a single technique into daily practice for the remaining 6 weeks. During the first 6 weeks, patients will have weekly check in meetings with a care manager to report on any withdrawal symptoms. These meetings will space to ever other week during the remaining 6 weeks. Possible treatment adjustments will be discussed between the care coordinator and primary investigator at weekly meetings. At the completion of the 12 week study, patients will complete outcome measures.	Usual Care Arm Patients will receive usual care.
Overall Study STARTED	2	4
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Intervention Arm Patients will receive the telecare intervention. Telecare Intervention: Patients will meet with a care coordinator to discuss current opioid use pattern and potential reduction strategies. Participants will fill out baseline measures. A 6 week positive psychology intervention will also be introduced in which patients will practice different techniques each week over 6 weeks, and will then practice incorporating a single technique into daily practice for the remaining 6 weeks. During the first 6 weeks, patients will have weekly check in meetings with a care manager to report on any withdrawal symptoms. These meetings will space to ever other week during the remaining 6 weeks. Possible treatment adjustments will be discussed between the care coordinator and primary investigator at weekly meetings. At the completion of the 12 week study, patients will complete outcome measures.	Usual Care Arm Patients will receive usual care.
Overall Study Lost to Follow-up	1	3

Baseline Characteristics

Collaborative Care for Opioid Dependence And Pain Pilot Study

Baseline characteristics by cohort

Measure	Intervention Arm n=2 Participants Patients will receive the telecare intervention. Telecare Intervention: Patients will meet with a care coordinator to discuss current opioid use pattern and potential reduction strategies. Participants will fill out baseline measures. A 6 week positive psychology intervention will also be introduced in which patients will practice different techniques each week over 6 weeks, and will then practice incorporating a single technique into daily practice for the remaining 6 weeks. During the first 6 weeks, patients will have weekly check in meetings with a care manager to report on any withdrawal symptoms. These meetings will space to ever other week during the remaining 6 weeks. Possible treatment adjustments will be discussed between the care coordinator and primary investigator at weekly meetings. At the completion of the 12 week study, patients will complete outcome measures.	Usual Care Arm n=4 Participants Patients will receive usual care.	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	49.0 years STANDARD_DEVIATION 12.7 • n=5 Participants	61.0 years STANDARD_DEVIATION 6.8 • n=7 Participants	57.0 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Opioid Dose	35.0 Morphine Milligram Equivalents STANDARD_DEVIATION 35.4 • n=5 Participants	27.5 Morphine Milligram Equivalents STANDARD_DEVIATION 21.8 • n=7 Participants	30 Morphine Milligram Equivalents STANDARD_DEVIATION 23.5 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Participants who completed the 12 week survey were included for analysis.

Percentage change in daily opioid morphine milligram equivalent (MME) dose

Outcome measures

Measure	Intervention Arm n=1 Participants Patients will receive the telecare intervention. Telecare Intervention: Patients will meet with a care coordinator to discuss current opioid use pattern and potential reduction strategies. Participants will fill out baseline measures. A 6 week positive psychology intervention will also be introduced in which patients will practice different techniques each week over 6 weeks, and will then practice incorporating a single technique into daily practice for the remaining 6 weeks. During the first 6 weeks, patients will have weekly check in meetings with a care manager to report on any withdrawal symptoms. These meetings will space to ever other week during the remaining 6 weeks. Possible treatment adjustments will be discussed between the care coordinator and primary investigator at weekly meetings. At the completion of the 12 week study, patients will complete outcome measures.	Usual Care Arm n=1 Participants Patients will receive usual care.
Opioid Dose Change	62.5 percentage of MME reduction Interval 62.5 to 62.5	50 percentage of MME reduction Interval 50.0 to 50.0

SECONDARY outcome

Timeframe: 12 weeks

The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.1 - Pain Interference 8a is an 8-item scale from the PROMIS item bank which assesses self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Each item has a 5-point Likert response, with total scores ranging from 8 - 40, with higher numbers corresponding to worse pain interference outcomes. For this outcome, the score at baseline was subtracted from the score at 12 weeks to determine the change score, with negative change scores demonstrating symptom improvement (i.e. less pain interference).

Outcome measures

Measure	Intervention Arm n=1 Participants Patients will receive the telecare intervention. Telecare Intervention: Patients will meet with a care coordinator to discuss current opioid use pattern and potential reduction strategies. Participants will fill out baseline measures. A 6 week positive psychology intervention will also be introduced in which patients will practice different techniques each week over 6 weeks, and will then practice incorporating a single technique into daily practice for the remaining 6 weeks. During the first 6 weeks, patients will have weekly check in meetings with a care manager to report on any withdrawal symptoms. These meetings will space to ever other week during the remaining 6 weeks. Possible treatment adjustments will be discussed between the care coordinator and primary investigator at weekly meetings. At the completion of the 12 week study, patients will complete outcome measures.	Usual Care Arm n=1 Participants Patients will receive usual care.
Change in PROMIS Pain Interference	-0.25 scores on a scale Interval -0.25 to -0.25	-0.63 scores on a scale Interval -0.63 to -0.63

Adverse Events

Intervention Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Usual Care Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention Arm n=2 participants at risk Patients will receive the telecare intervention. Telecare Intervention: Patients will meet with a care coordinator to discuss current opioid use pattern and potential reduction strategies. Participants will fill out baseline measures. A 6 week positive psychology intervention will also be introduced in which patients will practice different techniques each week over 6 weeks, and will then practice incorporating a single technique into daily practice for the remaining 6 weeks. During the first 6 weeks, patients will have weekly check in meetings with a care manager to report on any withdrawal symptoms. These meetings will space to ever other week during the remaining 6 weeks. Possible treatment adjustments will be discussed between the care coordinator and primary investigator at weekly meetings. At the completion of the 12 week study, patients will complete outcome measures.	Usual Care Arm n=4 participants at risk Patients will receive usual care.
Psychiatric disorders opioid withdrawal	50.0% 1/2 • Number of events 1 • 12 weeks	0.00% 0/4 • 12 weeks

Additional Information

Dr. Michael Bushey

Indiana University School of Medicine

Phone: 3179637300

Email: mabushey@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place