Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine

Opioid-use Disorder Clinical Trial

— OUTLAST-B  

Official title:

Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04991974
• Other study ID #: R01DA045724
• Secondary ID: R01DA045724
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• Start date: September 17, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Friends Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will examine the effectiveness of opioid use disorder (OUD) treatment linkage strategies for patients seen at sexual health clinics. This 3-arm RCT will compare Usual Care vs. Patient Navigation vs. Patient Navigation + Buprenorphine Initiation (UC vs. PN vs. PN+BUP).

Description:

This study, entitled Opioid Use Disorder Treatment Linkage at Sexual Health Clinics using Buprenorphine (OUTLAST-B), will examine opioid use disorder (OUD) treatment linkage strategies for people receiving sexual health services from public clinics and health departments. 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.

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 the sexual health clinic's buprenorphine-waivered provider (typically a nurse practitioner) 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 360
• Est. completion date: December 31, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

Behavioral:
• Patient 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).

Drug:
• Buprenorphine
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.

Locations

Country	Name	City	State
United States	Baltimore City Health Department Sexual Health Clinics	Baltimore	Maryland
United States	Friends Research Institute	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.	Baltimore City Health Department, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OUD treatment entry (number [%] of participants who enter OUD treatment)	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).	1 month
Secondary	OUD treatment retention	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.	6 months
Secondary	Opioid use (self-report)	Self-reported days of opioid use in the past 30 days	6 months
Secondary	Opioid use (urine test)	Opioid urine drug test	6 months
Secondary	Cocaine use (self-report)	Self-reported days of cocaine use in the past 30 days	6 months
Secondary	Cocaine use (urine test)	Cocaine urine drug test	6 months
Secondary	OUD diagnostic criteria	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.	6 months
Secondary	Opioid overdose	Participants will be asked at follow-up about non-fatal opioid overdose experiences. We will obtain medical examiner reports to confirm fatal overdoses.	6 months
Secondary	New Diagnoses of HIV/STIs	New diagnoses of HIV and sexually transmitted infections will be determined via self-report and health department records.	6 months
Secondary	Adherence to recommended HIV/STI treatment	Participants will be asked at follow-up whether they took as directed their specific HIV/STI medications, including (if applicable) any extended antibiotics for bacterial STDs, antiretroviral therapy for HIV+ participants, and PrEP to safeguard against acquiring HIV.	6 months
Secondary	Sex Risk Behaviors	Risky sex behaviors will be gauged by self-report, and include past 90 day frequency of unprotected sex and number of sex partners.	6 months
Secondary	Drug Risk Behaviors	Risky drug injection practices in the past 90-days, gauged by self-report	6 months