Opioid-use Disorder
Conditions
Brief summary
This study will examine the effectiveness of opioid use disorder (OUD) treatment linkage strategies for patients identified at sexual health clinics and through community outreach and referrals. This 3-arm RCT will compare Usual Care vs. Patient Navigation vs. Patient Navigation + Buprenorphine Initiation (UC vs. PN vs. PN+BUP).
Detailed description
This study, entitled Opioid Use Disorder Treatment Linkage at Strategic Touchpoints using Buprenorphine (OUTLAST-B), will examine opioid use disorder (OUD) treatment linkage strategies for people with untreated OUD, recruiting from sexual health clinics and through community outreach and referrals. This three-arm, parallel randomized clinical trial (RCT) will compare Usual Care (UC), vs. referral via Patient Navigation (PN), vs. Patient Navigation with buprenorphine initiation (PN+BUP). The UC Arm will include standard services at the sexual health clinic / city health department (if applicable), enhanced with brief overdose prevention education (including access to naloxone). The PN Arm will include all UC Arm services, with the addition of a Patient Navigator who will assist the participant in selecting a community OUD treatment program, facilitate an intake appointment, help to resolve barriers and coordinate OUD treatment entry, and support early retention in OUD treatment. The PN+BUP Arm will include all PN Arm services, with the addition of meeting with a study clinician to initiate buprenorphine treatment, as a bridge until successful transfer to OUD treatment in the community. Research assessments consisting of a structured interview battery and biomarkers for drug use and sexually transmitted infections will be conducted at baseline, 3-, and 6-month follow-up. Selected outcomes will be examined through 12-months via health record linkage methods. The study will examine participant outcomes in the domains of: (1) OUD treatment entry and retention, (2) Opioid use and related problems (including fatal and non-fatal overdose), and (3) HIV/STD-related outcomes.
Interventions
BEHAVIORALPatient Navigation
A Patient Navigator will work with participants to facilitate their entry into OUD treatment in the community (e.g., by selecting a program, scheduling intake appointments, and addressing barriers to facilitate successful treatment linkage).
DRUGBuprenorphine
Buprenorphine is an FDA-approved medication for opioid dependence, and will be used in this study consistent with its approved use (but will be initiated in the novel setting of sexual health clinics in this health services study). Participants will meet with an sexual health clinic provider who holds a waiver to prescribe buprenorphine. Participants will initiate buprenorphine treatment via a home induction under the direction of the provider. Because barriers to transfer may take some time to overcome, participants will be able to receive additional bridge buprenorphine up to two times (up to 15 days' supply at a time) until successful transfer to OUD treatment in the community.
Sponsors
Friends Research Institute, Inc.
National Institute on Drug Abuse (NIDA)
Baltimore City Health Department
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 or older 2. Opioid use in the past 30 days 3. DSM-5 diagnostic criteria for OUD with physiological dependence 4. Willing to try buprenorphine treatment.
Exclusion criteria
1. current enrollment in OUD treatment with buprenorphine, methadone, or extended-release naltrexone 2. clinical contraindication with buprenorphine (e.g., allergy to buprenorphine or naloxone, chronic pain management with opioid agonists) 3. regular use of illicit long-acting opioid agonists (e.g., methadone; due to potential challenges with dose induction) 4. heavy alcohol use that, in the judgement of the prescribing provider, raises a safety concern that precludes eligibility for buprenorphine induction 5. high dose or intravenous benzodiazepine misuse 6. pregnancy (due to special needs; will be treated outside of the study) 7. unstable medical or psychiatric illness (e.g., psychosis or active suicidal ideation) 8. inability to provide informed consent (e.g., failure to pass consent quiz)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OUD treatment entry (number [%] of participants who enter OUD treatment) | 1 month | The primary outcome for the trial is OUD treatment entry by 1 month post-enrollment, defined as admission to a buprenorphine provider (either office-based care or a specialty OUD program), or other licensed OUD treatment program (e.g., methadone, medical detox followed by behavioral treatment). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OUD treatment retention | 6 months | Treatment retention will be examined as a secondary outcome and will be determined by self-report, with confirmation of admission/discharge dates through provider records if available. |
| Opioid use (self-report) | 6 months | Self-reported days of opioid use in the past 30 days |
| Opioid use (urine test) | 6 months | Opioid urine drug test |
| Cocaine use (self-report) | 6 months | Self-reported days of cocaine use in the past 30 days |
| Cocaine use (urine test) | 6 months | Cocaine urine drug test |
| OUD diagnostic criteria | 6 months | Opioid use disorder diagnostic criteria will be assessed using items from the OUD criteria checklist derived from the modified World Mental Health-Composite International Diagnostic Interview (WMH-CIDI) items that map to the diagnostic criteria. The time frame of the criteria will be modified to past 30 days to capture acute changes. |
| Opioid overdose | 6 months | Participants will be asked at follow-up about non-fatal opioid overdose experiences. We will obtain medical examiner reports to confirm fatal overdoses. |
| Sex Risk Behaviors | 6 months | Risky sex behaviors will be gauged by self-report, and include past 90 day frequency of unprotected sex and number of sex partners. |
| Drug Risk Behaviors | 6 months | Risky drug injection practices in the past 90-days, gauged by self-report |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJan Gryczynski
Friends Research Institute, Inc.
Outcome results
None listed