Opioid-use Disorder, Medication Adherence, Health Care Utilization
Conditions
Keywords
Medications for opioid use disorder, Methadone, Buprenorphine, Behavioral Activation
Brief summary
This study seeks primarily to test, in a two-arm randomized controlled trial (RCT), the feasibility, acceptability, and preliminary efficacy of CoMBAT OUD, an intervention that integrates Behavioral Activation (BA) and substance abuse and health navigation counseling for individuals who are receiving medications for opioid use disorder (i.e., methadone; suboxone) to help them improve engagement in care and opioid use treatment outcomes. Participants will be randomized 1:1 to two arms: (1) the CoMBAT intervention (2 sessions of substance abuse and health navigation counseling + 8 sessions of BA counseling); or the (3) the standard of care (SOC) comparison condition, including two equivalent substance abuse and health navigation counseling. Participants will be followed for 6 months post-randomization, with assessments at months 3 and 6.
Detailed description
Opioid use disorder (OUD) is a chronic, relapsing disease and a major source of morbidity and mortality in the United States. Medications for opioid use disorder (i.e., methadone; buprenorphine) have been shown to reduce opioid use in diverse populations; however, long-term use of these medications and engagement in care are often suboptimal. Depression has been shown to contribute to medication discontinuation and care disengagement. Behavioral activation (BA) therapy is an evidence-based, behavioral treatment that has been shown to be effective in treating comorbid depression and substance use in diverse populations with smoking, alcohol, stimulant, and poly-substance use disorder. BA utilizes therapeutic techniques that help patients gradually increase goal-directed, potentially rewarding and pleasurable activities while decreasing the intensity and frequency of adverse events and consequences in order to improve mood. Given that BA utilizes strategies that can support individuals in alleviating depression and build the capacity to navigate life challenges, pairing BA with medications for OUD could help to ensure continued engagement in care and improve OUD treatment outcomes. This study, therefore, seeks to determine the feasibility of study procedures, enhance participant acceptability, and demonstrate preliminary efficacy of the CoMBAT (Combined Medication and Behavioral Activation Treatment) intervention. The investigators will enroll individuals currently being treated with methadone or buprenorphine for OUD in a pilot randomized controlled trial (RCT) of the CoMBAT intervention. Prior to randomization, participants will receive 2 health navigation and standard substance abuse counseling sessions. Participants will then be equally randomized to either: 1) the 8-session CoMBAT intervention; or 2) standard of care. The primary outcome is engagement in care. Secondary outcomes include self-reported days of opioid use and opioid-positive urinalysis. Intervention feasibility and acceptability will also be assessed. Participants will complete major assessment visits (survey and toxicology testing) at baseline and 3- and 6-months post-randomization.
Interventions
BEHAVIORALBehavioral Activation (BA) Therapy
8 sessions of behavioral activation therapy
BEHAVIORALSubstance Abuse and Health Navigation Counseling
2 standard substance abuse and health navigation counseling
OTHERMedications 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).
Sponsors
Boston University
University of Massachusetts, Boston
National Institute of General Medical Sciences (NIGMS)
Rhode Island Hospital
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two-arm RTC, randomized 1:1 to two arms: (1) the CoMBAT intervention (behavioral activation and substance abuse/health navigation) counseling, which lasts ten sessions; and (2) the standard of care comparison condition, including two equivalent substance abuse/ health navigation counseling sessions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 years or older * Initiated medications for opioid use \>= 30 day prior to screening * Current depressive symptoms * Plans to stay in Rhode Island or Massachusetts for at least 6-months * Able to read, speak, and understand English * Willing and able to provide informed consent
Exclusion criteria
* Does not plan to continue taking medications for opioid use disorder * Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview * Discovery of active suicidal ideation at the time of interview * In the second or third trimester of pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Missed Medication Doses - Past 30 Days | Baseline, 3 month follow-up, and 6 month follow-up | 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. |
| Number of Missed Medication-related Visits - Past 30 Days | Baseline, 3 month follow-up, and 6 month follow-up | Self-reported change in the number of medication-related clinic visits missed in the past 30 days from baseline to follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fentanyl and Opiate-positive Urine Toxicology Screen | Baseline, 3 month follow-up, and 6 month follow-up | 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) |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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). | 16 |
| 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). | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Standard of Care | Experimental | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 16 Participants | 31 Participants |
| Age, Continuous | 39.4 years STANDARD_DEVIATION 11.6 | 39.9 years STANDARD_DEVIATION 10.98 | 39.6 years STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 16 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Medication Type Buprenorphine | 5 Participants | 4 Participants | 9 Participants |
| Medication Type Methadone | 11 Participants | 12 Participants | 23 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 13 Participants | 12 Participants | 25 Participants |
| Region of Enrollment United States | 16 participants | 16 participants | 32 participants |
| Sex: Female, Male Female | 3 Participants | 8 Participants | 11 Participants |
| Sex: Female, Male Male | 13 Participants | 8 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Number of Missed Medication Doses - Past 30 Days
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.
Time frame: Baseline, 3 month follow-up, and 6 month follow-up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CoMBAT (Experimental) | Number of Missed Medication Doses - Past 30 Days | Baseline | 3.13 Number of missed doses | Standard Deviation 3.48 |
| CoMBAT (Experimental) | Number of Missed Medication Doses - Past 30 Days | 3 Month Follow-Up | 3.71 Number of missed doses | Standard Deviation 4.41 |
| CoMBAT (Experimental) | Number of Missed Medication Doses - Past 30 Days | 6 Month Follow-Up | 1.19 Number of missed doses | Standard Deviation 2.43 |
| Standard of Care (SOC; Control) | Number of Missed Medication Doses - Past 30 Days | 6 Month Follow-Up | 1.69 Number of missed doses | Standard Deviation 4.29 |
| Standard of Care (SOC; Control) | Number of Missed Medication Doses - Past 30 Days | Baseline | 2.81 Number of missed doses | Standard Deviation 3 |
| Standard of Care (SOC; Control) | Number of Missed Medication Doses - Past 30 Days | 3 Month Follow-Up | 2.25 Number of missed doses | Standard Deviation 3 |
Comparison: Hypothesis: The CoMBAT intervention arm would be superior to the Standard of Care control arm with regard to reductions in missed medication doses in the past 30 days at follow-up.p-value: 0.1795% CI: [-1.11, 0.2]Generalized estimating equations (GEE)
Primary
Number of Missed Medication-related Visits - Past 30 Days
Self-reported change in the number of medication-related clinic visits missed in the past 30 days from baseline to follow-up.
Time frame: Baseline, 3 month follow-up, and 6 month follow-up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CoMBAT (Experimental) | Number of Missed Medication-related Visits - Past 30 Days | Baseline | 1.13 Number of missed visits | Standard Deviation 1.2 |
| CoMBAT (Experimental) | Number of Missed Medication-related Visits - Past 30 Days | 3 Month Follow-Up | 0.14 Number of missed visits | Standard Deviation 0.36 |
| CoMBAT (Experimental) | Number of Missed Medication-related Visits - Past 30 Days | 6 Month Follow-Up | 0.06 Number of missed visits | Standard Deviation 0.03 |
| Standard of Care (SOC; Control) | Number of Missed Medication-related Visits - Past 30 Days | Baseline | 0.94 Number of missed visits | Standard Deviation 0.85 |
| Standard of Care (SOC; Control) | Number of Missed Medication-related Visits - Past 30 Days | 3 Month Follow-Up | 0.25 Number of missed visits | Standard Deviation 0.45 |
| Standard of Care (SOC; Control) | Number of Missed Medication-related Visits - Past 30 Days | 6 Month Follow-Up | 0.06 Number of missed visits | Standard Deviation 0.35 |
Comparison: Hypothesis: The CoMBAT intervention arm would be superior to the Standard of Care control arm with regard to reductions in missed medication-related visits in the past 30 days at follow-up.p-value: 0.995% CI: [-3.09, 2.72]Generalized estimating equation (GEE)
Secondary
Fentanyl and Opiate-positive Urine Toxicology Screen
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)
Time frame: Baseline, 3 month follow-up, and 6 month follow-up
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CoMBAT (Experimental) | Fentanyl and Opiate-positive Urine Toxicology Screen | Baseline | 6 Participants |
| CoMBAT (Experimental) | Fentanyl and Opiate-positive Urine Toxicology Screen | 3 Month Follow-Up | 3 Participants |
| CoMBAT (Experimental) | Fentanyl and Opiate-positive Urine Toxicology Screen | 6 Month Follow-Up | 2 Participants |
| Standard of Care (SOC; Control) | Fentanyl and Opiate-positive Urine Toxicology Screen | Baseline | 3 Participants |
| Standard of Care (SOC; Control) | Fentanyl and Opiate-positive Urine Toxicology Screen | 3 Month Follow-Up | 4 Participants |
| Standard of Care (SOC; Control) | Fentanyl and Opiate-positive Urine Toxicology Screen | 6 Month Follow-Up | 3 Participants |
Comparison: Hypothesis: Fewer participants in the CoMBAT experimental arm will have a positive opioid toxicology screen at the 6-month follow-up compared to participants in the SOC control arm.p-value: 0.0295% CI: [-8.72, -0.7]Generalized estimating equations (GEE)