Trial Outcomes & Findings for CoMBAT Opioid Use Disorder: A Combined Medication and Behavioral Activation Treatment for People Living With Opioid Use Disorder (NCT NCT04240093)
NCT ID: NCT04240093
Last Updated: 2023-05-26
Results Overview
Self-reported change in the number of missed methadone or buprenorphine doses in the past 30 days. Raw, unadjusted means at 6-month follow-up are reported.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
Baseline, 3 month follow-up, and 6 month follow-up
Results posted on
2023-05-26
Participant Flow
Participants were recruited via ads posted online (i.e., Craigslist) and in-person at outpatient substance use treatment clinics and community organizations serving people who use drugs in Rhode Island and Massachusetts. Substance use treatment providers and staff also provided direct referrals and snowball sampling was used.
A total of 44 individuals consented; of these, 12 individuals were lost to follow-up prior to randomization, resulting in a randomized sample of 32 participants (16 CoMBAT experimental arm; 16 Standard of Care control arm).
Participant milestones
| Measure |
Experimental
Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds
Behavioral Activation (BA) Therapy: 8 sessions of behavioral activation therapy
Substance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling
Medications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).
|
Standard of Care
Substance Abuse and Health Navigation Counseling (2 sessions) + Meds
Substance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling
Medications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
3 Month Follow-Up
|
14
|
16
|
|
Overall Study
6 Month Follow Up
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CoMBAT Opioid Use Disorder: A Combined Medication and Behavioral Activation Treatment for People Living With Opioid Use Disorder
Baseline characteristics by cohort
| Measure |
Experimental
n=16 Participants
Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds
Behavioral Activation (BA) Therapy: 8 sessions of behavioral activation therapy
Substance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling
Medications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).
|
Standard of Care
n=16 Participants
Substance Abuse and Health Navigation Counseling (2 sessions) + Meds
Substance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling
Medications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).
|
Total
n=32 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
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 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
|
39.9 years
STANDARD_DEVIATION 10.98 • n=5 Participants
|
39.4 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
39.6 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Medication Type
Methadone
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Medication Type
Buprenorphine
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 month follow-up, and 6 month follow-upPopulation: Intent to Treat Analysis. For the unadjusted means by time-point data, there were missing data for 2 participants in the CoMBAT experimental arm at the 3-month follow-up visit.
Self-reported change in the number of missed methadone or buprenorphine doses in the past 30 days. Raw, unadjusted means at 6-month follow-up are reported.
Outcome measures
| Measure |
CoMBAT (Experimental)
n=16 Participants
Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds
Behavioral Activation (BA) Therapy: 8 sessions of behavioral activation therapy
Substance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling
Medications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).
|
Standard of Care (SOC; Control)
n=16 Participants
Substance Abuse and Health Navigation Counseling (2 sessions) + Meds
Substance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling
Medications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).
|
|---|---|---|
|
Number of Missed Medication Doses - Past 30 Days
Baseline
|
3.13 Number of missed doses
Standard Deviation 3.48
|
2.81 Number of missed doses
Standard Deviation 3.00
|
|
Number of Missed Medication Doses - Past 30 Days
3 Month Follow-Up
|
3.71 Number of missed doses
Standard Deviation 4.41
|
2.25 Number of missed doses
Standard Deviation 3.00
|
|
Number of Missed Medication Doses - Past 30 Days
6 Month Follow-Up
|
1.19 Number of missed doses
Standard Deviation 2.43
|
1.69 Number of missed doses
Standard Deviation 4.29
|
PRIMARY outcome
Timeframe: Baseline, 3 month follow-up, and 6 month follow-upPopulation: Intent to Treat Analysis. For the unadjusted means by time-point data, there were missing data for 2 participants in the CoMBAT experimental arm at the 3-month follow-up visit.
Self-reported change in the number of medication-related clinic visits missed in the past 30 days from baseline to follow-up.
Outcome measures
| Measure |
CoMBAT (Experimental)
n=16 Participants
Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds
Behavioral Activation (BA) Therapy: 8 sessions of behavioral activation therapy
Substance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling
Medications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).
|
Standard of Care (SOC; Control)
n=16 Participants
Substance Abuse and Health Navigation Counseling (2 sessions) + Meds
Substance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling
Medications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).
|
|---|---|---|
|
Number of Missed Medication-related Visits - Past 30 Days
Baseline
|
1.13 Number of missed visits
Standard Deviation 1.20
|
0.94 Number of missed visits
Standard Deviation 0.85
|
|
Number of Missed Medication-related Visits - Past 30 Days
3 Month Follow-Up
|
0.14 Number of missed visits
Standard Deviation 0.36
|
0.25 Number of missed visits
Standard Deviation 0.45
|
|
Number of Missed Medication-related Visits - Past 30 Days
6 Month Follow-Up
|
0.06 Number of missed visits
Standard Deviation 0.03
|
0.06 Number of missed visits
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Baseline, 3 month follow-up, and 6 month follow-upPopulation: Intent to Treat Analysis. For the raw count data, there were missing data for 2 participants in the CoMBAT experimental arm at the 3-month follow-up visit.
Fentanyl or opiate-positive urine screen (opiates refer to natural opioids such as heroin, morphine so buprenorphine, methadone, and other synthetic opioids are not included)
Outcome measures
| Measure |
CoMBAT (Experimental)
n=16 Participants
Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds
Behavioral Activation (BA) Therapy: 8 sessions of behavioral activation therapy
Substance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling
Medications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).
|
Standard of Care (SOC; Control)
n=16 Participants
Substance Abuse and Health Navigation Counseling (2 sessions) + Meds
Substance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling
Medications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).
|
|---|---|---|
|
Fentanyl and Opiate-positive Urine Toxicology Screen
Baseline
|
6 Participants
|
3 Participants
|
|
Fentanyl and Opiate-positive Urine Toxicology Screen
3 Month Follow-Up
|
3 Participants
|
4 Participants
|
|
Fentanyl and Opiate-positive Urine Toxicology Screen
6 Month Follow-Up
|
2 Participants
|
3 Participants
|
Adverse Events
Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place