Opioid Dependence
Conditions
Keywords
Opioid dependence, Buprenorphine, primary care treatment, extended-release buprenorphine
Brief summary
This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry.
Interventions
DRUGBuprenorphine Extended Release
XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.
SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.
Sponsors
New York City Health and Hospitals Corporation
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults \>18yo incarcerated in NYC jails with known release dates. * DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence). * Currently maintained on sublingual buprenorphine-naloxone in the NYC jail opioid treatment program.
Exclusion criteria
* Individual not interested in XRB treatment. Current SLB patients are otherwise by definition appropriate for XRB. * Pregnant or planning conception. A urine dipstick pregnancy (hCG) test will be administered at baseline. The test detects human chorionic gonadotropin (hCG) in urine with a sensitivity/specificity of: 25 mIU hCG/ml, \>99%. Time to result is four minutes. If negative, a urine pregnancy test will be administered bi-weekly thereafter to ensure that a participant is not pregnant * No severe or acute medical or psychiatric disability preventing safe study participation or making follow-up unlikely.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Mean In-jail Medical Visits Per Day Following Randomization and Induction on Study Medication | Post-randomization and pre-release, (0-3 months) | Jail medical clinic visits per day following study medication induciton, mean |
| Urine Samples Opioid-negative | 8 weeks | number of opioid-negative urine samples |
| the # of Participants Re-incarcerated | 8 weeks | Re-incarceration |
| # of Participants Retained on Any Form of Community Buprenorphine (Not Randomzied tx) at Week 8 | 8 Weeks | Retained on any form of community buprenorphine treatment at Week 8 |
| # of Participants Retained on Their Randomly Assigned Treatment at Week 8 | 8 weeks | Retained on assigned treatment at Week 8 |
| Mean # of Weeks (0-8) on Any Buprenorphine Treatment | 8 weeks | Weeks (0-8) on buprenorphine treatment, mean (SD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled | 0-3 months (pre-release) | Received assigned study medication prior to release as scheduled |
| The # of Participants That Received Their Randomly Assigned Study Medication | 8 Weeks | Received assigned study medication |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Buprenorphine Extended-Release XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.
Buprenorphine Extended Release: XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle. | 26 |
| Sublingual Buprenorphine SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.
Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets): SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response. | 26 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 7 |
Baseline characteristics
| Characteristic | Buprenorphine Extended-Release | Total | Sublingual Buprenorphine |
|---|---|---|---|
| Age, Continuous | 43.1 years STANDARD_DEVIATION 9.2 | 42.7 years STANDARD_DEVIATION 10 | 42.3 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 23 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 29 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 15 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 17 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 19 Participants | 12 Participants |
| Region of Enrollment United States | 26 participants | 52 participants | 26 participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Male | 23 Participants | 45 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 5 / 26 | 3 / 26 |
| serious Total, serious adverse events | 2 / 26 | 0 / 26 |
Outcome results
Primary
Mean # of Weeks (0-8) on Any Buprenorphine Treatment
Weeks (0-8) on buprenorphine treatment, mean (SD)
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buprenorphine Extended-Release | Mean # of Weeks (0-8) on Any Buprenorphine Treatment | 6.1 weeks | Standard Deviation 3.5 |
| Sublingual Buprenorphine | Mean # of Weeks (0-8) on Any Buprenorphine Treatment | 2.6 weeks | Standard Deviation 3.2 |
Primary
# of Participants Retained on Any Form of Community Buprenorphine (Not Randomzied tx) at Week 8
Retained on any form of community buprenorphine treatment at Week 8
Time frame: 8 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buprenorphine Extended-Release | # of Participants Retained on Any Form of Community Buprenorphine (Not Randomzied tx) at Week 8 | 18 Participants |
| Sublingual Buprenorphine | # of Participants Retained on Any Form of Community Buprenorphine (Not Randomzied tx) at Week 8 | 9 Participants |
Primary
# of Participants Retained on Their Randomly Assigned Treatment at Week 8
Retained on assigned treatment at Week 8
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buprenorphine Extended-Release | # of Participants Retained on Their Randomly Assigned Treatment at Week 8 | 15 Participants |
| Sublingual Buprenorphine | # of Participants Retained on Their Randomly Assigned Treatment at Week 8 | 9 Participants |
Primary
The Mean In-jail Medical Visits Per Day Following Randomization and Induction on Study Medication
Jail medical clinic visits per day following study medication induciton, mean
Time frame: Post-randomization and pre-release, (0-3 months)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Buprenorphine Extended-Release | The Mean In-jail Medical Visits Per Day Following Randomization and Induction on Study Medication | 0.11 jail clinic visits per day |
| Sublingual Buprenorphine | The Mean In-jail Medical Visits Per Day Following Randomization and Induction on Study Medication | 1.06 jail clinic visits per day |
Primary
the # of Participants Re-incarcerated
Re-incarceration
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buprenorphine Extended-Release | the # of Participants Re-incarcerated | 2 Participants |
| Sublingual Buprenorphine | the # of Participants Re-incarcerated | 4 Participants |
Primary
Urine Samples Opioid-negative
number of opioid-negative urine samples
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Buprenorphine Extended-Release | Urine Samples Opioid-negative | 72 urine samples |
| Sublingual Buprenorphine | Urine Samples Opioid-negative | 50 urine samples |
Secondary
The # of Participants That Received Their Randomly Assigned Study Medication
Received assigned study medication
Time frame: 8 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buprenorphine Extended-Release | The # of Participants That Received Their Randomly Assigned Study Medication | 24 Participants |
| Sublingual Buprenorphine | The # of Participants That Received Their Randomly Assigned Study Medication | 26 Participants |
Secondary
The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled
Received assigned study medication prior to release as scheduled
Time frame: 0-3 months (pre-release)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buprenorphine Extended-Release | The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled | 21 Participants |
| Sublingual Buprenorphine | The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled | 26 Participants |