Opioid UseNCT04521920
Providing Suboxone and PrEP Using Telemedicine
A study testing Suboxone and PrEP in people with Opioid Use and Opioid-use Disorder, run by Duke University at 3 sites in United States.
Trial summary
The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, and pre-exposure prophylaxis (PrEP) for HIV prevention for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Opioid-use Disorder, Risk Reduction
- What is being tested?
- Suboxone and PrEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Nov 2020to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of self-report injection opioid use in the past 6 months
- Participate in SSPs,
- HIV negative
- Willing to take bup/nx and PrEP for 6 months
- No medical contraindications for these medications
- Not pregnant
Show all 10Show fewer
- 18 years or older
- Not currently taking PrEP
- Not currently taking any form of MOUD
- History of sharing injection or drug preparation equipment or risk of sexual acquisition of HIV (such as engaging in sex work or men who have sex with men) in the past 6 months
Who cannot join
- Positive pregnancy test including during the course of the study
- Positive HIV test at enrollment
- Altered mental status in which participant cannot sign a consent form
- Renal insufficiency/failure
- Hepatitis B surface antigen positive
- Becoming incarcerated during the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Queen City Needle Exchnge
Charlotte, North Carolina, 28215
Duke Department of Population Health Sciences
Durham, North Carolina, 27701
North Carolina Harm Reduction Coalition
Wilmington, North Carolina, 28403
About this study
Official title: Providing Comprehensive Harm Reduction Via Telemedicine for PWID Using Syringe Services Programs: a Feasibility Study
The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, and pre-exposure prophylaxis (PrEP) for HIV prevention for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess the acceptability and feasibility of using telemedicine to implement the program.
The initial visit will be conducted in person or remotely via telemedicine given COVID-19 protocols at the SSP sites in Charlotte and Wilmington, North Carolina (NC); follow-up visits will be conducted via telemedicine.
Read the detailed description
The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, and pre-exposure prophylaxis (PrEP) for HIV prevention for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess the acceptability and feasibility of using telemedicine to implement the program.
The study objectives are the following:
- To assess uptake and persistence to bup/nx and PrEP as part of a comprehensive harm reduction program among people who inject drugs using SSPs.
- To assess feasibility and acceptability of implementing a telemedicine-based MOUD and PrEP program
The study population is people who inject drugs, specifically opioids, and who access services at SSPs in Charlotte and Wilmington, NC. The study team will enroll 20 PWID accessing the participating SSPs in Charlotte and Wilmington, NC (10 from each site). Participants will be enrolled in the study for 6 months. At the end of the study, they will be referred to MOUD and PrEP providers identified in the community.
Data collection
Enrollment visit:
The study coordinator will administer the SOCRATES 8D and a baseline survey to collect demographics, HIV risk behaviors, and substance use history. Participants will undergo laboratory testing at the SSP to determine eligibility and enrolled participants will be prescribed bup/nx and PrEP free of charge.
Follow up visits:
Follow-up visits will be conducted via telemedicine at the SSPs. For the first month (Month 1), telemedicine visits will be weekly with each study participant to ensure that they are stable on the appropriate bup/nx dose. Starting at Month 2, the telemedicine visits will take place monthly. Participants will be asked to complete a questionnaire at Month 3 and Month 6 which include questions on HIV risk and drug use, as well as adherence evaluation for both bup/nx and PrEP.
By the end of the study, we hope to determine the following:
- The proportion of persons who demonstrate no or minimal opioid use
- The proportion of persons who remain HIV negative.
- Retention or persistence in care
We will also examine whether participants are more apt to remain on paired/combined therapy compared to individual treatment.
Under the secondary ID, IRB Pro00104148, we will conduct an ancillary study to contribute to the overall feasibility purpose of the primary study (Pro00104147) by collecting qualitative data from program users. The ancillary study will include conducting in-depth interviews (IDIs) with 10 to 20 participants in the primary study at the end of their month 1 telemedicine visit and at the end of their month 6 telemedicine visit (completion of the primary study). We will use applied thematic analysis to analyze participants' narratives. We chose to position this assessment within an ancillary protocol rather that embed it within the primary study in order to reduce the potential for socially desirable responses.
- Conditions
- Opioid Use, Opioid-use Disorder, Risk Reduction, Hiv
- Being tested
- Suboxone, PrEP
- Keywords
- opioid, medication for opioid use disorder, syringe services program, telemedicine, PrEP, HIV prevention, retention in care, suboxone, buprenorphine, feasibility, acceptability
- Medical subject headings
- Opioid-Related Disorders, Risk Reduction Behavior, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuboxoneDrug
Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
PrEPDrug
Also called Pre-Exposure Prophylaxis (PrEP)
Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
| Study group | Role | What they receive |
|---|---|---|
| Medication and telemedicine follow up | Experimental | All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine Receives: Drug: Suboxone; Drug: PrEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Demonstrate no or Minimal Opioid Use at 3 Months
Defined as self-reported opioid use in prior month
Measured: 3 months
Number of Participants Who Demonstrate no or Minimal Opioid Use at 6 Months
Defined as self-reported opioid use in prior month.
Measured: 6 months
Number of Participants Who Remain HIV Negative at 3 Months
Measured via negative HIV test.
Measured: 3 months
Number of Participants Who Remain HIV Negative at 6 Months
Measured via negative HIV test.
Measured: 6 months
Persistence in Care at 3 Months
Defined as the number of participants who remain on treatment (MOUD or PrEP).
Measured: 3 months
Persistence in Care at 6 Months
Defined as the number of participants who remain on treatment (MOUD or PrEP).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start9 Nov 2020
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Duke 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehri McKellar, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521920
- Sponsor's protocol ID
- Pro00104147
- Other IDs
- Pro00104148
- Status last verified
- Jun 2023
- First submitted
- 18 Aug 2020
- Last updated
- 9 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share IPD with other researchers.
Publications
Mars SG, Bourgois P, Karandinos G, Montero F, Ciccarone D. "Every 'never' I ever said came true": transitions from opioid pills to heroin injecting. Int J Drug Policy. 2014 Mar;25(2):257-66. doi: 10.1016/j.drugpo.2013.10.004. Epub 2013 Oct 19.
PubMed 24238956Lankenau SE, Teti M, Silva K, Jackson Bloom J, Harocopos A, Treese M. Initiation into prescription opioid misuse amongst young injection drug users. Int J Drug Policy. 2012 Jan;23(1):37-44. doi: 10.1016/j.drugpo.2011.05.014. Epub 2011 Jun 20.
PubMed 21689917Young AM, Havens JR. Transition from first illicit drug use to first injection drug use among rural Appalachian drug users: a cross-sectional comparison and retrospective survival analysis. Addiction. 2012 Mar;107(3):587-96. doi: 10.1111/j.1360-0443.2011.03635.x. Epub 2011 Oct 26.
PubMed 21883604Al-Tayyib AA, Rice E, Rhoades H, Riggs P. Association between prescription drug misuse and injection among runaway and homeless youth. Drug Alcohol Depend. 2014 Jan 1;134:406-409. doi: 10.1016/j.drugalcdep.2013.10.027. Epub 2013 Nov 7.
PubMed 24300900Valdez A, Neaigus A, Cepeda A. Potential risk factors for injecting among Mexican American non-injecting heroin users. J Ethn Subst Abuse. 2007;6(2):49-73. doi: 10.1300/J233v06n02_05.
PubMed 18192204Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Kitisin P, Natrujirote P, Kittimunkong S, Chuachoowong R, Gvetadze RJ, McNicholl JM, Paxton LA, Curlin ME, Hendrix CW, Vanichseni S; Bangkok Tenofovir Study Group. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2013 Jun 15;381(9883):2083-90. doi: 10.1016/S0140-6736(13)61127-7. Epub 2013 Jun 13.
PubMed 23769234Velander JR. Suboxone: Rationale, Science, Misconceptions. Ochsner J. 2018 Spring;18(1):23-29. No abstract available.
PubMed 29559865Sullivan LE, Moore BA, Chawarski MC, Pantalon MV, Barry D, O'Connor PG, Schottenfeld RS, Fiellin DA. Buprenorphine/naloxone treatment in primary care is associated with decreased human immunodeficiency virus risk behaviors. J Subst Abuse Treat. 2008 Jul;35(1):87-92. doi: 10.1016/j.jsat.2007.08.004. Epub 2007 Oct 15.
PubMed 17933486Bazzi AR, Biancarelli DL, Childs E, Drainoni ML, Edeza A, Salhaney P, Mimiaga MJ, Biello KB. Limited Knowledge and Mixed Interest in Pre-Exposure Prophylaxis for HIV Prevention Among People Who Inject Drugs. AIDS Patient Care STDS. 2018 Dec;32(12):529-537. doi: 10.1089/apc.2018.0126. Epub 2018 Oct 11.
PubMed 30311777Edelman EJ, Moore BA, Calabrese SK, Berkenblit G, Cunningham C, Patel V, Phillips K, Tetrault JM, Shah M, Fiellin DA, Blackstock O. Primary Care Physicians' Willingness to Prescribe HIV Pre-exposure Prophylaxis for People who Inject Drugs. AIDS Behav. 2017 Apr;21(4):1025-1033. doi: 10.1007/s10461-016-1612-6.
PubMed 27896552Molfenter T, Fitzgerald M, Jacobson N, McCarty D, Quanbeck A, Zehner M. Barriers to Buprenorphine Expansion in Ohio: A Time-Elapsed Qualitative Study. J Psychoactive Drugs. 2019 Jul-Aug;51(3):272-279. doi: 10.1080/02791072.2019.1566583. Epub 2019 Feb 7.
PubMed 30732542Haffajee RL, Lin LA, Bohnert ASB, Goldstick JE. Characteristics of US Counties With High Opioid Overdose Mortality and Low Capacity to Deliver Medications for Opioid Use Disorder. JAMA Netw Open. 2019 Jun 5;2(6):e196373. doi: 10.1001/jamanetworkopen.2019.6373.
PubMed 31251376Zheng W, Nickasch M, Lander L, Wen S, Xiao M, Marshalek P, Dix E, Sullivan C. Treatment Outcome Comparison Between Telepsychiatry and Face-to-face Buprenorphine Medication-assisted Treatment for Opioid Use Disorder: A 2-Year Retrospective Data Analysis. J Addict Med. 2017 Mar/Apr;11(2):138-144. doi: 10.1097/ADM.0000000000000287.
PubMed 28107210Weintraub E, Greenblatt AD, Chang J, Himelhoch S, Welsh C. Expanding access to buprenorphine treatment in rural areas with the use of telemedicine. Am J Addict. 2018 Dec;27(8):612-617. doi: 10.1111/ajad.12805. Epub 2018 Sep 28.
PubMed 30265425Centers for Disease Control and Prevention. Revised guidelines for HIV counseling, testing, and referral. MMWR Recomm Rep. 2001 Nov 9;50(RR-19):1-57; quiz CE1-19a1-CE6-19a1.
PubMed 11718472
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Comprehensive Harm Reduction Via Telemedicine for PWID Using Syringe Services Programs: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04521920
- Acronym / sponsor ID
- Pro00104147
- Conditions
- Opioid Use, Opioid-use Disorder, Risk Reduction, Hiv
- Keywords
- opioid, medication for opioid use disorder, syringe services program, telemedicine, PrEP, HIV prevention, retention in care, suboxone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Posted 8 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, and pre-exposure prophylaxis (PrEP) for HIV prevention for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess the acceptability and feasibility of using telemedicine to implement the program.
The initial visit will be conducted in person or remotely via telemedicine given COVID-19 protocols at the SSP sites in Charlotte and Wilmington, North Carolina (NC); follow-up visits will be conducted via telemedicine.
Detailed description
The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, and pre-exposure prophylaxis (PrEP) for HIV prevention for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess the acceptability and feasibility of using telemedicine to implement the program.
The study objectives are the following:
- To assess uptake and persistence to bup/nx and PrEP as part of a comprehensive harm reduction program among people who inject drugs using SSPs.
- To assess feasibility and acceptability of implementing a telemedicine-based MOUD and PrEP program
The study population is people who inject drugs, specifically opioids, and who access services at SSPs in Charlotte and Wilmington, NC. The study team will enroll 20 PWID accessing the participating SSPs in Charlotte and Wilmington, NC (10 from each site). Participants will be enrolled in the study for 6 months. At the end of the study, they will be referred to MOUD and PrEP providers identified in the community.
Data collection
Enrollment visit:
The study coordinator will administer the SOCRATES 8D and a baseline survey to collect demographics, HIV risk behaviors, and substance use history. Participants will undergo laboratory testing at the SSP to determine eligibility and enrolled participants will be prescribed bup/nx and PrEP free of charge.
Follow up visits:
Follow-up visits will be conducted via telemedicine at the SSPs. For the first month (Month 1), telemedicine visits will be weekly with each study participant to ensure that they are stable on the appropriate bup/nx dose. Starting at Month 2, the telemedicine visits will take place monthly. Participants will be asked to complete a questionnaire at Month 3 and Month 6 which include questions on HIV risk and drug use, as well as adherence evaluation for both bup/nx and PrEP.
By the end of the study, we hope to determine the following:
- The proportion of persons who demonstrate no or minimal opioid use
- The proportion of persons who remain HIV negative.
- Retention or persistence in care
We will also examine whether participants are more apt to remain on paired/combined therapy compared to individual treatment.
Under the secondary ID, IRB Pro00104148, we will conduct an ancillary study to contribute to the overall feasibility purpose of the primary study (Pro00104147) by collecting qualitative data from program users. The ancillary study will include conducting in-depth interviews (IDIs) with 10 to 20 participants in the primary study at the end of their month 1 telemedicine visit and at the end of their month 6 telemedicine visit (completion of the primary study). We will use applied thematic analysis to analyze participants' narratives. We chose to position this assessment within an ancillary protocol rather that embed it within the primary study in order to reduce the potential for socially desirable responses.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medication and telemedicine follow up | Experimental | Drug: Suboxone, Drug: PrEPAll participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- History of self-report injection opioid use in the past 6 months
- Participate in SSPs,
- HIV negative
- Willing to take bup/nx and PrEP for 6 months
- No medical contraindications for these medications
Key exclusion criteria (6 listed)
- Positive pregnancy test including during the course of the study
- Positive HIV test at enrollment
- Altered mental status in which participant cannot sign a consent form
- Renal insufficiency/failure
- Hepatitis B surface antigen positive
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 |
|---|---|---|
| SuboxoneEnrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up. | Drug | Medication and telemedicine follow up |
| PrEPAlso: Pre-Exposure Prophylaxis (PrEP)Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up. | Drug | Medication and telemedicine follow up |
Primary outcome
Number of Participants Who Demonstrate no or Minimal Opioid Use at 3 Months
Time frame: 3 months
Defined as self-reported opioid use in prior month
Number of Participants Who Demonstrate no or Minimal Opioid Use at 6 Months
Time frame: 6 months
Defined as self-reported opioid use in prior month.
Number of Participants Who Remain HIV Negative at 3 Months
Time frame: 3 months
Measured via negative HIV test.
Number of Participants Who Remain HIV Negative at 6 Months
Time frame: 6 months
Measured via negative HIV test.
Persistence in Care at 3 Months
Time frame: 3 months
Defined as the number of participants who remain on treatment (MOUD or PrEP).
Persistence in Care at 6 Months
Time frame: 6 months
Defined as the number of participants who remain on treatment (MOUD or PrEP).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24238956Mars SG, Bourgois P, Karandinos G, Montero F, Ciccarone D. "Every 'never' I ever said came true": transitions from opioid pills to heroin injecting. Int J Drug Policy. 2014 Mar;25(2):257-66. doi: 10.1016/j.drugpo.2013.10.004. Epub 2013 Oct 19.
- Background: PubMed 21689917Lankenau SE, Teti M, Silva K, Jackson Bloom J, Harocopos A, Treese M. Initiation into prescription opioid misuse amongst young injection drug users. Int J Drug Policy. 2012 Jan;23(1):37-44. doi: 10.1016/j.drugpo.2011.05.014. Epub 2011 Jun 20.
- Background: PubMed 21883604Young AM, Havens JR. Transition from first illicit drug use to first injection drug use among rural Appalachian drug users: a cross-sectional comparison and retrospective survival analysis. Addiction. 2012 Mar;107(3):587-96. doi: 10.1111/j.1360-0443.2011.03635.x. Epub 2011 Oct 26.
- Background: PubMed 24300900Al-Tayyib AA, Rice E, Rhoades H, Riggs P. Association between prescription drug misuse and injection among runaway and homeless youth. Drug Alcohol Depend. 2014 Jan 1;134:406-409. doi: 10.1016/j.drugalcdep.2013.10.027. Epub 2013 Nov 7.
- Background: PubMed 18192204Valdez A, Neaigus A, Cepeda A. Potential risk factors for injecting among Mexican American non-injecting heroin users. J Ethn Subst Abuse. 2007;6(2):49-73. doi: 10.1300/J233v06n02_05.
- Background: PubMed 23769234Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Kitisin P, Natrujirote P, Kittimunkong S, Chuachoowong R, Gvetadze RJ, McNicholl JM, Paxton LA, Curlin ME, Hendrix CW, Vanichseni S; Bangkok Tenofovir Study Group. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2013 Jun 15;381(9883):2083-90. doi: 10.1016/S0140-6736(13)61127-7. Epub 2013 Jun 13.
- Background: PubMed 29559865Velander JR. Suboxone: Rationale, Science, Misconceptions. Ochsner J. 2018 Spring;18(1):23-29. No abstract available.
- Background: PubMed 17933486Sullivan LE, Moore BA, Chawarski MC, Pantalon MV, Barry D, O'Connor PG, Schottenfeld RS, Fiellin DA. Buprenorphine/naloxone treatment in primary care is associated with decreased human immunodeficiency virus risk behaviors. J Subst Abuse Treat. 2008 Jul;35(1):87-92. doi: 10.1016/j.jsat.2007.08.004. Epub 2007 Oct 15.
- Background: PubMed 30311777Bazzi AR, Biancarelli DL, Childs E, Drainoni ML, Edeza A, Salhaney P, Mimiaga MJ, Biello KB. Limited Knowledge and Mixed Interest in Pre-Exposure Prophylaxis for HIV Prevention Among People Who Inject Drugs. AIDS Patient Care STDS. 2018 Dec;32(12):529-537. doi: 10.1089/apc.2018.0126. Epub 2018 Oct 11.
- Background: PubMed 27896552Edelman EJ, Moore BA, Calabrese SK, Berkenblit G, Cunningham C, Patel V, Phillips K, Tetrault JM, Shah M, Fiellin DA, Blackstock O. Primary Care Physicians' Willingness to Prescribe HIV Pre-exposure Prophylaxis for People who Inject Drugs. AIDS Behav. 2017 Apr;21(4):1025-1033. doi: 10.1007/s10461-016-1612-6.
- Background: PubMed 30732542Molfenter T, Fitzgerald M, Jacobson N, McCarty D, Quanbeck A, Zehner M. Barriers to Buprenorphine Expansion in Ohio: A Time-Elapsed Qualitative Study. J Psychoactive Drugs. 2019 Jul-Aug;51(3):272-279. doi: 10.1080/02791072.2019.1566583. Epub 2019 Feb 7.
- Background: PubMed 31251376Haffajee RL, Lin LA, Bohnert ASB, Goldstick JE. Characteristics of US Counties With High Opioid Overdose Mortality and Low Capacity to Deliver Medications for Opioid Use Disorder. JAMA Netw Open. 2019 Jun 5;2(6):e196373. doi: 10.1001/jamanetworkopen.2019.6373.
- Individual participant dataSharing planned: No. We will not share IPD with other researchers.
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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.
Mehri McKellar, MD principal investigator
Duke Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suboxone and PrEP in people with Opioid Use and Opioid-use Disorder, run by Duke University at 3 sites in United States.
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 10 inclusion and 6 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 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 8 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Demonstrate no or Minimal Opioid Use at 3 Months (time frame: 3 months). The study lists 6 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 NCT04521920, which also lists 17 linked publications.
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 9 Jun 2023.