Opioid AddictionTCN-PATHSNCT04309565
Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support
A study testing Transitions Clinic Network Primary Care and Standard Primary Care in people with Opioid Addiction, run by Yale University at 5 sites in 2 countries.
Trial summary
TCN PATHS will recruit an anticipated 400 participants who are prescribed MOUD who are released from detention facilities. Each individual will be randomized to either 1) standard primary care (SPC) or 2) a Transitions Clinic Network (TCN) program primary care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Addiction
- What is being tested?
- Transitions Clinic Network Primary Care and Standard Primary Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 21 Apr 2021to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- English and Spanish-speaking,
- Meeting current DSM-5 criteria for OUD
Who cannot join
- acutely psychotic, suicidal or homicidal,
- require prescription opioids for acute pain, chronic pain or palliative care without OUD,
- have a planned relocation that makes it unlikely they would be able to complete the study and follow-up assessments,
- have a primary care provider that they already have established care with in the community,
- women of child-bearing age will be excluded if they are pregnant
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
UNC Chapel Hill
Chapel Hill, North Carolina, 27510
Hennepin Healthcare
Minneapolis, Minnesota, 55404
Yale
New Haven, Connecticut, 06511
Albert Einstein College of Medicine
The Bronx, New York, 10467
About this study
TCN PATHS will recruit an anticipated 400 participants who are prescribed MOUD who are released from detention facilities. Each individual will be randomized to either 1) standard primary care (SPC) or 2) a Transitions Clinic Network (TCN) program primary care. Participants will be followed for a year and complete surveys at baseline and at month 1, 3, 6, 9, and 12. At each of these points research staff will confirm MOUD status. Urine drug screenings will be completed at baseline, month 1, 6, and 12 if the participant is not incarcerated. When possible, research staff will collect electronic health records.
Read the detailed description
Purpose: The overall objective of this study is to assess whether the Transitions Clinic Network (TCN) program, which provides enhanced primary care and opioid use disorder (OUD) treatment for people recently released from incarceration, improves measures in the opioid treatment cascade compared to referral to standard primary care.
Participants: An anticipated 400 individuals currently receiving medications for OUD released from eight local jails (Durham, NC; Minneapolis, MN; Bronx, NY; Bridgeport and Niantic, CT; and Bayamón and Ponce, Puerto Rico)
Procedures: This is a hybrid type I effectiveness-implementation trial will randomize an anticipated 400 participants to one of two treatment conditions: TCN or standard primary care. People will complete the enrollment process while in jail (recruitment, screening, consent, baseline assessments, and randomization). Due to COVID-19 restrictions some jails are limiting researcher assess to people and some of our sites may enroll participants once they are released, this is referred to as a community enrollment. Post participants will meet with research assistants for a structured interview and urine toxicology screening at 1, 6, and 12 months, and a phone interview at months 3 and 9. 120 people will be selected to participate in Intensive Longitudinal Assessment (ILA) to access both the acceptability and appropriateness of the TCN intervention and the multi-level facilitators and barriers of OUD treatment engagement in the first 30 days following release from incarceration.
- Conditions
- Opioid Addiction
- Being tested
- Transitions Clinic Network Primary Care, Standard Primary Care
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitions Clinic Network Primary CareBehavioural
Transitions Clinic Network (TCN)- participants in this arm will be referred to a TCN program for primary care and community Opioid Treatment Program (OTP). All TCN programs have the ability to prescribe buprenorphine and Extended-release naltrexone (XR-NTX) and assist with referrals to methadone. The primary features of the TCN include (1) primary care and onsite MOUD or referral to community treatment when indicated, (2) addressing social determinants of OUD and care coordination through a Community Health Worker (CHW), and (3) addressing the discrimination and stigma that exist based on incarceration.
Standard Primary CareBehavioural
Those randomized to the standard primary care arm will be referred to primary care and community Opioid Treatment Program (OTP). Participants may receive buprenorphine or Extended-release naltrexone (XR-NTX) through primary care or with a community addiction treatment provider.
| Study group | Role | What they receive |
|---|---|---|
| Standard Primary Care | Active comparator | Those randomized to the standard primary care arm will be referred to primary care and community Opioid Treatment Program (OTP). Participants may receive buprenorphine or Extended-release naltrexone (XR-NTX) through primary care or with a community addiction treatment provider. Receives: Behavioral: Standard Primary Care |
| Transitions Clinic Network Primary Care | Experimental | Transitions Clinic Network (TCN)- participants in this arm will be referred to a TCN program for primary care and community Opioid Treatment Program (OTP). All TCN programs have the ability to prescribe buprenorphine and Extended-release naltrexone (XR-NTX) and assist with referrals to methadone. The primary features of the TCN include (1) primary care and onsite MOUD or referral to community treatment when indicated, (2) addressing social determinants of OUD and care coordination through a Community Health Worker (CHW), and (3) addressing the discrimination and stigma that exist based on incarceration. Receives: Behavioral: Transitions Clinic Network Primary Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement in opioid use disorder (OUD) treatment
The primary study outcome will be engagement in OUD treatment within 30 days of jail release, defined as treatment consistent with the American Society of Addiction Medicine's levels of care (1-4), which allows for a range of treatments and clinical settings consistent with patient's needs and preference (e.g., office-based providers of buprenorphine or naltrexone, OTPs, or intensive outpatient, inpatient, or residential treatments). Patients do not need to be receiving methadone, buprenorphine, or naltrexone formulations (MOUD) to be considered engaged in OUD treatment. This will be measured based on questions about engagement in OUD treatment. These responses will be used to calculate a count of participants engaged in OUD treatment. As appropriate, this information will be confirmed in the electronic health record or with the addiction treatment facilities after obtaining a signed release.
Measured: 30 days following jail release
Retention in OUD treatment
Retention in community OUD treatment will defined in accordance with the American Society of Addiction Medicine's levels of care (1-4), which allows for a range of treatments and clinical settings consistent with patient's needs and preference (e.g., office-based providers of buprenorphine or naltrexone, OTPs, or intensive outpatient, inpatient, or residential treatments). Patients do not need to be receiving MOUD to be considered retained in OUD treatment. Consistent with our prior research, this will be measured based on a Yes/No question about engagement in OUD treatment from the Treatment Services Review (TSR). These responses will be used to calculate a count of participants engaged in OUD treatment. As appropriate, this information will be confirmed in the electronic health record or with the addiction treatment facilities after obtaining a signed release. Re-incarceration (and resumption of MOUD in jail) will not count as retained in community OUD treatment.
Measured: 12 months following jail release
Retention on medication for OUD (MOUD)
Retention on MOUD will be defined as receipt of any of the 3 FDA approved medications for OUD (methadone, buprenorphine, naltrexone) within 7 days of the index date (release from jail/interview date) regardless of what MOUD participants were on at baseline prior to release. This measure will be collected by using self report and as appropriate, will confirm self-report in the electronic health record or with the addiction treatment facilities after obtaining a signed release.
Measured: 12 months following initial jail release
Percent days of illicit opioid use
Investigators will measure percent days of illicit opioid use during study time frames. Investigators will measure this by asking the participant how many days during the study time frame have they used illicit opioids. A urine toxicology that is positive for illicit opioids on testing will count as three days of using illicit opioids. Using the data from the
Measured: 12 months following initial jail release
Secondary outcomes (4)
Retention in primary care
Retention in primary care which is defined as 2 or more visits to primary care in twelve months. Participants will be asked to self-report the number of visits and this data will be used to count the number of participants retained in primary care.
Measured: 12 months following jail release
Overdose
Participants will be asked about overdose events using self-report, when applicable, be supplemented by data from the electronic health record which will indicate visits to the emergency department and hospitalizations for overdose. In at least four TCN program sites, investigators will have access to administrative payer data (Medicaid) where investigators will be able to examine time to overdose as a secondary outcome. This data will be used to calculate a count of participants experiencing an overdose event
Measured: 12 months following initial jail release
Time to Overdose
In at least four of the six TCN program sites, investigators will have access to administrative payer data (Medicaid) where investigators will be able to examine time to overdose as a secondary outcome. This data will be used to calculate time to overdose for each participant for each overdose event.
Measured: 12 months following initial jail release
Death
Participant death will be collected using the electronic health record. In at least four of the six TCN program sites, investigators will have access to vital statistics data where survival analyses will be conducting with mortality as a secondary outcome.
Measured: 12 months following initial jail release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start21 Apr 2021
- Primary completion30 Oct 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid AddictionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid type I effectiveness-implementation trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, University of Puerto Rico, University of Rochester, University of Miami, University of California, San Francisco, University of Connecticut, Albert Einstein College of Medicine, Hennepin Healthcare Research Institute, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Emily Wang, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309565
- Sponsor's protocol ID
- 2000027469
- Other IDs
- 1UG1DA050072-01
- Acronym
- TCN-PATHS
- Status last verified
- May 2026
- First submitted
- 12 Mar 2020
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Howell BA, Puglisi L, Clark K, Albizu-Garcia C, Ashkin E, Booth T, Brinkley-Rubinstein L, Fiellin DA, Fox AD, Maurer KF, Lin HJ, McCollister K, Murphy S, Morse DS, Shavit S, Wang K, Winkelman T, Wang EA. The Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support (TCN-PATHS): A hybrid type-1 effectiveness trial of enhanced primary care to improve opioid use disorder treatment outcomes following release from jail. J Subst Abuse Treat. 2021 Sep;128:108315. doi: 10.1016/j.jsat.2021.108315. Epub 2021 Jan 29.
PubMed 33583610
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support
- ClinicalTrials.gov ID
- NCT04309565
- Acronym / sponsor ID
- TCN-PATHS / 2000027469
- Conditions
- Opioid Addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, University of Puerto Rico, University of Rochester, University of Miami, University of California, San Francisco, University of Connecticut, Albert Einstein College of Medicine, Hennepin Healthcare Research Institute, National Institute on Drug Abuse (NIDA)
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TCN PATHS will recruit an anticipated 400 participants who are prescribed MOUD who are released from detention facilities. Each individual will be randomized to either 1) standard primary care (SPC) or 2) a Transitions Clinic Network (TCN) program primary care. Participants will be followed for a year and complete surveys at baseline and at month 1, 3, 6, 9, and 12. At each of these points research staff will confirm MOUD status. Urine drug screenings will be completed at baseline, month 1, 6, and 12 if the participant is not incarcerated. When possible, research staff will collect electronic health records.
Detailed description
Purpose: The overall objective of this study is to assess whether the Transitions Clinic Network (TCN) program, which provides enhanced primary care and opioid use disorder (OUD) treatment for people recently released from incarceration, improves measures in the opioid treatment cascade compared to referral to standard primary care.
Participants: An anticipated 400 individuals currently receiving medications for OUD released from eight local jails (Durham, NC; Minneapolis, MN; Bronx, NY; Bridgeport and Niantic, CT; and Bayamón and Ponce, Puerto Rico)
Procedures: This is a hybrid type I effectiveness-implementation trial will randomize an anticipated 400 participants to one of two treatment conditions: TCN or standard primary care. People will complete the enrollment process while in jail (recruitment, screening, consent, baseline assessments, and randomization). Due to COVID-19 restrictions some jails are limiting researcher assess to people and some of our sites may enroll participants once they are released, this is referred to as a community enrollment. Post participants will meet with research assistants for a structured interview and urine toxicology screening at 1, 6, and 12 months, and a phone interview at months 3 and 9. 120 people will be selected to participate in Intensive Longitudinal Assessment (ILA) to access both the acceptability and appropriateness of the TCN intervention and the multi-level facilitators and barriers of OUD treatment engagement in the first 30 days following release from incarceration.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Hybrid type I effectiveness-implementation trial
| Arm | Type | Receives |
|---|---|---|
| Standard Primary Care | Active comparator | Behavioral: Standard Primary CareThose randomized to the standard primary care arm will be referred to primary care and community Opioid Treatment Program (OTP). Participants may receive buprenorphine or Extended-release naltrexone (XR-NTX) through primary care or with a community addiction treatment provider. |
| Transitions Clinic Network Primary Care | Experimental | Behavioral: Transitions Clinic Network Primary CareTransitions Clinic Network (TCN)- participants in this arm will be referred to a TCN program for primary care and community Opioid Treatment Program (OTP). All TCN programs have the ability to prescribe buprenorphine and Extended-release naltrexone (XR-NTX) and assist with referrals to methadone. The primary features of the TCN include (1) primary care and onsite MOUD or referral to community treatment when indicated, (2) addressing social determinants of OUD and care coordination through a Community Health Worker (CHW), and (3) addressing the discrimination and stigma that exist based on incarceration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- English and Spanish-speaking,
- Meeting current DSM-5 criteria for OUD
Key exclusion criteria (5 listed)
- acutely psychotic, suicidal or homicidal,
- require prescription opioids for acute pain, chronic pain or palliative care without OUD,
- have a planned relocation that makes it unlikely they would be able to complete the study and follow-up assessments,
- have a primary care provider that they already have established care with in the community,
- women of child-bearing age will be excluded if they are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transitions Clinic Network Primary CareTransitions Clinic Network (TCN)- participants in this arm will be referred to a TCN program for primary care and community Opioid Treatment Program (OTP). All TCN programs have the ability to prescribe buprenorphine and Extended-release naltrexone (XR-NTX) and assist with referrals to methadone. The primary features of the TCN include (1) primary care and onsite MOUD or referral to community treatment when indicated, (2) addressing social determinants of OUD and care coordination through a Community Health Worker (CHW), and (3) addressing the discrimination and stigma that exist based on incarceration. | Behavioural | Transitions Clinic Network Primary Care |
| Standard Primary CareThose randomized to the standard primary care arm will be referred to primary care and community Opioid Treatment Program (OTP). Participants may receive buprenorphine or Extended-release naltrexone (XR-NTX) through primary care or with a community addiction treatment provider. | Behavioural | Standard Primary Care |
Primary outcome
Engagement in opioid use disorder (OUD) treatment
Time frame: 30 days following jail release
The primary study outcome will be engagement in OUD treatment within 30 days of jail release, defined as treatment consistent with the American Society of Addiction Medicine's levels of care (1-4), which allows for a range of treatments and clinical settings consistent with patient's needs and preference (e.g., office-based providers of buprenorphine or naltrexone, OTPs, or intensive outpatient, inpatient, or residential treatments). Patients do not need to be receiving methadone, buprenorphine, or naltrexone formulations (MOUD) to be considered engaged in OUD treatment. This will be measured based on questions about engagement in OUD treatment. These responses will be used to calculate a count of participants engaged in OUD treatment. As appropriate, this information will be confirmed in the electronic health record or with the addiction treatment facilities after obtaining a signed release.
Retention in OUD treatment
Time frame: 12 months following jail release
Retention in community OUD treatment will defined in accordance with the American Society of Addiction Medicine's levels of care (1-4), which allows for a range of treatments and clinical settings consistent with patient's needs and preference (e.g., office-based providers of buprenorphine or naltrexone, OTPs, or intensive outpatient, inpatient, or residential treatments). Patients do not need to be receiving MOUD to be considered retained in OUD treatment. Consistent with our prior research, this will be measured based on a Yes/No question about engagement in OUD treatment from the Treatment Services Review (TSR). These responses will be used to calculate a count of participants engaged in OUD treatment. As appropriate, this information will be confirmed in the electronic health record or with the addiction treatment facilities after obtaining a signed release. Re-incarceration (and resumption of MOUD in jail) will not count as retained in community OUD treatment.
Retention on medication for OUD (MOUD)
Time frame: 12 months following initial jail release
Retention on MOUD will be defined as receipt of any of the 3 FDA approved medications for OUD (methadone, buprenorphine, naltrexone) within 7 days of the index date (release from jail/interview date) regardless of what MOUD participants were on at baseline prior to release. This measure will be collected by using self report and as appropriate, will confirm self-report in the electronic health record or with the addiction treatment facilities after obtaining a signed release.
Percent days of illicit opioid use
Time frame: 12 months following initial jail release
Investigators will measure percent days of illicit opioid use during study time frames. Investigators will measure this by asking the participant how many days during the study time frame have they used illicit opioids. A urine toxicology that is positive for illicit opioids on testing will count as three days of using illicit opioids. Using the data from the
4 secondary outcomes
Retention in primary care
Time frame: 12 months following jail release
Overdose
Time frame: 12 months following initial jail release
Time to Overdose
Time frame: 12 months following initial jail release
Death
Time frame: 12 months following initial jail release
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 33583610Howell BA, Puglisi L, Clark K, Albizu-Garcia C, Ashkin E, Booth T, Brinkley-Rubinstein L, Fiellin DA, Fox AD, Maurer KF, Lin HJ, McCollister K, Murphy S, Morse DS, Shavit S, Wang K, Winkelman T, Wang EA. The Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support (TCN-PATHS): A hybrid type-1 effectiveness trial of enhanced primary care to improve opioid use disorder treatment outcomes following release from jail. J Subst Abuse Treat. 2021 Sep;128:108315. doi: 10.1016/j.jsat.2021.108315. Epub 2021 Jan 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Wang, MD principal investigator
Yale University
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitions Clinic Network Primary Care and Standard Primary Care in people with Opioid Addiction, run by Yale University at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement in opioid use disorder (OUD) treatment (time frame: 30 days following jail release). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04309565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.