Injectable Buprenorphine in Prison: A Preference Trial
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorLifespan
About this trial
The goal of this pilot trial is to compare two branded extended-release buprenorphine (XR-B) formulations (Sublocade vs. Brixadi) to explore how they improve treatment retention after release from prison among incarcerated individuals with opioid use disorder (OUD) who are transitioning back into the community.
The main question it aims to answer are:
How do Sublocade and Brixadi compare in terms of feasibility, acceptability, and effectiveness? Does giving people a choice of medication affect how well they stay in treatment?
Using a partially randomized preference trial approach, there will be a comparison between participants who choose their XR-B formulation to those who are randomly assigned to see if patient preference influences treatment outcomes. The trial is a hybrid implementation-effectiveness trial.
Participants will:
* Choose which medication they prefer or be randomly assigned if they don't have a preference. * Receive monthly injections of either Sublocade or Brixadi before and after release from prison. * Complete surveys and clinical assessments on treatment experience and acceptability. * Be monitored for treatment retention, opioid use, and adverse events for six months post-release.
Researchers will compare the two treatments to see which one works better for people leaving prison and if allowing people to choose their treatment improves results.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
be at least 18 years of age and incarcerated in the RIDOC facility,
be currently diagnosed with OUD and enrolled in the RIDOC MOUD program,
have an expected release date within 120 days of study enrollment,
have an interest in XR-B and
Disqualifiers
individuals who are pregnant or planning conception,
diagnosed with a severe or acute medical or psychiatric disability preventing safe study participation or making follow-up unlikely,
have a release date within 21 days of initiation, or
have previously had an allergy to buprenorphine. Post-enrollment exclusion will include individuals if there is a change in release date beyond the 120 days and therefore no longer meet original inclusion criteria. These individuals would return to usual MOUD care.
Trial design
Design model
Parallel
Treatments tested in this trial
Brixadi (Injectable Buprenorphine)
DrugBrixadi comes in several doses and can be administered on a weekly or monthly basis. For clinical reasons (i.e., each patient will already be on a stable dose of MOUD in a setting without significant illicit opioid use), the monthly injection will be used. The approximately equivalent to the 300mg Sublocade dose is 96mg of Brixadi. The maximum dose is 128mg. Brixadi can be administered in the abdomen, buttocks, or triceps. Participants in the Brixadi treatment arm will be given one or more Brixadi injections each month prior to release from prison and each month after release. They can continue to receive the medication after the conclusion of the trial. Brixadi is covered by most Medicaid health insurances in the state of Rhode Island.
Sublocade
DrugSublocade is a 100mg or 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. Participants in the Sublocade treatment arm will be given monthly Sublocade injections, as clinically indicated, each month prior to release from prison and each month after release. They can continue to receive the medication after the conclusion of the trial. Sublocade is covered by most Medicaid health insurances in the state of Rhode Island. The standard dosing schedule is two months of 300mg followed by monthly 100mg injections. To maximize real-world generalizability, the medication dosing will be determined by clinical indication of the provider who will have the flexibility to provide medication dosing based on their clinical acumen and/or shared decision-making.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: SublocadeActive comparator 1 intervention
Group B: BrixadiActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Preliminary Effectiveness
Preliminary Effectiveness will be measured through rates of community treatment continuation post-release. Outpatient treatment engagement over the first three months post-release will be assessed using study records of CPC Recovery Clinic follow-up appointments. For patients that do not follow at the CPC Recovery Clinic, statewide administrative data from the Rhode Island Prescription Drug Monitoring Program (PDMP) database covering community pharmacy fills of buprenorphine products will be used to supplement treatment retention outcomes. PDMP data will also be used to track community treatment continuation for all participants from three to six months post-release. Participants will be logged as continuing buprenorphine treatment at each month if: (1) CPC Recovery Clinic records show that they were present at their scheduled follow-up visit, or (2) the PDMP indicates that they continued treatment elsewhere and have not had a gap of more than 30 days in dispensed medication.
Time frame
3 months post-release2
Implementation Outcomes: Acceptability
Acceptability will be measured through initial patient preference, in-facility treatment retention, and the validated Acceptability of Intervention Measure (AIM). The Acceptability of Intervention Measure (AIM) assesses the extent to which an intervention is perceived as satisfactory or agreeable by stakeholders. Scores are calculated using a 5-point Likert scale, where 1 = Completely Disagree and 5 = Completely Agree. The minimum possible score is 1, and the maximum possible score is 5. Higher scores indicate greater acceptability of the intervention.
Time frame
Baseline, Immediately after the intervention3
Implementation Outcomes: Feasibility
Feasibility will be measured by the validated Feasibility of Intervention Measure (FIM) and enrollment rates. The Feasibility of Intervention Measure (FIM) evaluates the degree to which an intervention can be successfully used or implemented within a given setting. Scores are calculated using a 5-point Likert scale, where 1 = Completely Disagree and 5 = Completely Agree. The minimum possible score is 1, and the maximum possible score is 5. Higher scores indicate greater feasibility of implementing the intervention.
Time frame
Baseline, Immediately after the intervention4
Implementation Outcomes: Appropriateness
Appropriateness will be measured by the validated Intervention Appropriateness Measure (IAM). The Appropriateness of Intervention Measure (IAM) measures how well an intervention fits with the setting, needs, or problem it is intended to address. Scores are calculated using a 5-point Likert scale, where 1 = Completely Disagree and 5 = Completely Agree. The minimum possible score is 1, and the maximum possible score is 5. Higher scores indicate greater perceived appropriateness of the intervention.
Time frame
Baseline, Immediately after the interventionSecondary outcomes
1
Client Outcomes: Satisfaction
Treatment Satisfaction will be assessed using a modified version of the previously validated Treatment Satisfaction Questionnaire for Medication (TSQM-9) after each in-facility injection. TSQM scoring is by domain and each domain score is computed by summing the individual TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100, 100 as highly satisfied.
Time frame
During the intervention2
Client Outcomes: Function - Healthcare Utilization
Healthcare utilization will be assessed using emergency department or hospital visits will be tracked using Rhode Island Hospital CPC Recovery Clinic Electronic Medical Record data.
Time frame
During the intervention3
Client Outcomes: Function - Recidivism
Reincarceration will be tracked using RIDOC administrative data identifying return to jail or prison.
Time frame
During the intervention, 3 months after the intervention4
Client Outcomes: Treatment Satisfaction
Treatment Satisfaction will be assessed using a modified version of the previously validated Treatment Satisfaction Questionnaire for Medication (TSQM-9) after each in-facility injection.
Time frame
During the interventionSponsors and contacts
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Lifespan
Lead sponsor
Rhode Island Hospital
Sponsor institution
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov