Opioid-Related DisordersNCT03098407
Opioid Dependence Treatment Therapies in Pregnancy
A study testing Buprenorphine and Methadone in people with Opioid-Related Disorders and Pregnancy, run by University of Pittsburgh at 1 site in United States.
Trial summary
The incidence of opioid dependence in pregnancy increased over the last decade from 1.2 to 5.8 per 1,000 hospital births per year.1 While methadone is the current, standard treatment for opioid dependent (OD) pregnant women, buprenorphine recently emerged as an alternative. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Opioid-Related Disorders, Pregnancy
- What is being tested?
- Buprenorphine and Methadone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2017to 5 Oct 2020
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women 18+ years old, with a singleton pregnancy ≤ 28 weeks gestation confirmed by ultrasound, who meet Diagnostic and Statistical Manual-IV criteria for opioid dependence confirmed by urine drug screen (UDS), who are interested in opioid maintenance treatment and plan to receive prenatal care and deliver at Magee Womens Hospital (MWH) will be recruited.
Who cannot join
- (1) active, current dependence on benzodiazepines or alcohol
- (2) acute severe psychiatric condition in need of immediate treatment (e.g. suicidal ideations)
- (3) pending or legal action that could prohibit or interfere with participation (e.g. incarceration)
- (4) current, established treatment with methadone or buprenorphine. Exclusion criteria are based on the Substance Abuse and Mental Health Services Administration (SAMHSA) recommendations for office-based buprenorphine use.
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Pilot Randomized Comparative Effectiveness Clinical Trial of Buprenorphine vs. Methadone for the Treatment of Opioid Dependence in Pregnancy.
The incidence of opioid dependence in pregnancy increased over the last decade from 1.2 to 5.8 per 1,000 hospital births per year.1 While methadone is the current, standard treatment for opioid dependent (OD) pregnant women, buprenorphine recently emerged as an alternative. In a recent clinical trial (MOTHER), buprenorphine was associated with superior neonatal outcomes such as shorter duration of treatment for neonatal abstinence syndrome (NAS) compared to methadone. However, buprenorphine was also associated with greater study discontinuation (33% vs. 18%) and illicit opioid use (33% vs. 23%) compared to methadone. Treatment dropout often leads to relapse and resumption of high-risk behaviors, overshadowing any short-term improvement in neonatal outcomes. Therefore, The goal of this K23 proposal is to conduct a pilot study to establish the feasibility and acceptability of a randomized comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally licensed methadone programs for the treatment of OD pregnant women.
A pilot study is critical to develop the outcome measures, assessment tools and participant tracking techniques necessary for a future, large-scale comparative effectiveness clinical trial. An examination of feasibility and acceptability will also allow use to characterize the subpopulations of OD pregnant women willing to participate in treatment randomization, identify patient and provider characteristics associated with established treatment preferences and inform the development of strategies to improve participation and enhance the generalizability of the future large-scale clinical trial.
Read the detailed description
Objective:
The goal of this proposal is to conduct a pilot study to establish the feasibility and acceptability of a randomized comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally licensed methadone programs for the treatment of opioid dependent pregnant women.
Specific Aims:
Aim 1: Evaluate the feasibility of conducting a randomized study comparing office-based buprenorphine vs. federally licensed methadone programs for the treatment of OD pregnant women. OD pregnant women (n=50) will be randomized (1:1) to office-based buprenorphine vs. a federally licensed methadone program. Feasibility will be assessed by measuring the proportion of OD pregnant women who are eligible, who enroll, who remain in the study and by the ability to monitor treatment program factors (e.g. compliance with treatment provider/facility visits, counseling sessions, prenatal care visits, social services involvement) and maternal treatment outcomes such as treatment retention, illicit drug use and HIV risk behavior.
Aim 2: Describe the perspectives of OD pregnant women and their providers regarding buprenorphine vs. methadone for the treatment of opioid dependence in pregnancy. Study acceptability will be assessed by conducting qualitative semi-structured interviews with three groups: (1) pilot participants to determine their satisfaction with the assigned treatment program and identify mismatches between treatment program services and participants' needs; (2) prenatal care and opioid treatment providers to identify ways to improve the treatment process in pregnancy and to suggest ideas for care coordination; (3) OD pregnant women who are ineligible or who choose not to participate in the pilot trial will also be asked to participate in an interview to gain a broader perspective of attitudes and perspectives regarding opioid treatment programs in pregnancy.
Aim 3: Identify barriers and facilitators to treatment retention in the postpartum period and identify key functional outcomes relevant to reductions in illicit drug use during pregnancy. Illicit drug use relapse is most common in the immediate postpartum period when stresses associated with motherhood are the greatest. Therefore, pilot participants will be followed at 3, 6, 9 and 12 weeks postpartum to identify barriers and facilitators specific to the postpartum period that may impact treatment retention. The relationship between postpartum treatment retention and maternal functional outcomes will also be explored (e.g. breastfeeding, postpartum depression, motherhood satisfaction, infant custody, employment, and criminality).
Background:
The incidence of opioid dependence in pregnancy increased over the last decade from 1.2 to 5.8 per 1,000 hospital births per year. While methadone is the current, standard treatment for opioid dependent (OD) pregnant women, buprenorphine recently emerged as an alternative. In a recent clinical trial (MOTHER), buprenorphine was associated with superior neonatal outcomes such as shorter duration of treatment for neonatal abstinence syndrome (NAS) compared to methadone. However, buprenorphine was also associated with greater study discontinuation (33% vs. 18%) and illicit opioid use (33% vs. 23%) compared to methadone. Treatment dropout often leads to relapse and resumption of high-risk behaviors, overshadowing any short-term improvement in neonatal outcomes. Therefore, the next research question that emerges is which is the most effective treatment (buprenorphine vs. methadone) for a particular patient during pregnancy?
In clinical settings, differences in maternal characteristics, treatment program structure and patient and provider preferences may surpass the impact of pharmacology on maternal treatment outcomes (treatment retention, illicit drug use, HIV risk behavior). Buprenorphine is dispensed in office-based settings by a variety of providers and with less regulatory oversight than methadone. Methadone is dispensed from federally licensed facilities that often incorporate counseling and support services into treatment protocols. Successful office-based treatment relies on shared power and responsibility, close patient-provider relationships and careful attention to psychosocial co-morbidities. Failure to match patient problem severity to differences in treatment program structure may contribute to adverse maternal outcomes. Therefore, to understand the comparative effectiveness of buprenorphine vs. methadone in pregnancy, the impact of patient problem severity and treatment program structure on maternal (vs. neonatal) outcomes must be compared.
Significance:
Findings from this project will provide the preliminary data to support a comparative effectiveness clinical trial designed to compare the impact of office-based buprenorphine vs. federally licensed methadone programs on maternal treatment and postpartum functional outcomes in OD women. The ultimate goal of this line of research is develop evidence-based clinical guidelines to guide provider decision-making regarding the most effective treatment (buprenorphine vs. methadone) for a particular patient during pregnancy.
- Conditions
- Opioid-Related Disorders, Pregnancy
- Being tested
- Buprenorphine, Methadone
- 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.
BuprenorphineDrug
This is a pilot study to establish the feasibility and acceptability of a randomized comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally licensed methadone treatment programs for OD pregnant women.
MethadoneDrug
This is a pilot study to establish the feasibility and acceptability of a randomized comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally licensed methadone treatment programs for OD pregnant women.
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine Maintenance Treatment | Other | Buprenorphine Maintenance Treatment patients will receive instructions regarding a follow-up, outpatient appointment with the Pregnancy Recovery Center at Magee-Womens Hospital, which specializes in Opioid maintenance treatment for pregnant patients, for the next day following enrollment in the study for induction onto buprenorphine maintenance treatment. Receives: Drug: Buprenorphine |
| Methadone Maintenance Treatment | Other | Methadone Maintenance Treatment patients will be immediately admitted to Magee-Womens Hospital for an inpatient induction onto methadone maintenance treatment. Receives: Drug: Methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who are recruited, enrolled, retained, and who complete the study.
evaluate a minimum of 9 OD pregnant women per month for possible participation and enrollment, randomize a minimum of 4 participants per month to office-based buprenorphine (PRC) or methadone treatment facility (NATP) for a total of 50 participants over a 12 month enrollment period, retain ≥ 80% of randomized participants until 12 weeks postpartum, and maintain < 5% of incomplete data.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start20 Apr 2017
- Primary completion9 Oct 2019
- Study completion5 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (61)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Elizabeth Krans, MD, University of Pittsburgh
- Investigators
- Elizabeth E Krans, MD, MSc, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098407
- Sponsor's protocol ID
- PRO16020403
- Other IDs
- 1K23DA038789-01A1
- Status last verified
- Nov 2020
- First submitted
- 24 Oct 2016
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patrick SW, Schumacher RE, Benneyworth BD, Krans EE, McAllister JM, Davis MM. Neonatal abstinence syndrome and associated health care expenditures: United States, 2000-2009. JAMA. 2012 May 9;307(18):1934-40. doi: 10.1001/jama.2012.3951. Epub 2012 Apr 30.
PubMed 22546608Meyer MC, Johnston AM, Crocker AM, Heil SH. Methadone and buprenorphine for opioid dependence during pregnancy: a retrospective cohort study. J Addict Med. 2015 Mar-Apr;9(2):81-6. doi: 10.1097/ADM.0000000000000092.
PubMed 25622120Jones HE, Heil SH, Baewert A, Arria AM, Kaltenbach K, Martin PR, Coyle MG, Selby P, Stine SM, Fischer G. Buprenorphine treatment of opioid-dependent pregnant women: a comprehensive review. Addiction. 2012 Nov;107 Suppl 1(0 1):5-27. doi: 10.1111/j.1360-0443.2012.04035.x.
PubMed 23106923Goodman D. Buprenorphine for the treatment of perinatal opioid dependence: pharmacology and implications for antepartum, intrapartum, and postpartum care. J Midwifery Womens Health. 2011 May-Jun;56(3):240-7. doi: 10.1111/j.1542-2011.2011.00049.x.
PubMed 21535372Fischer G, Gombas W, Eder H, Jagsch R, Peternell A, Stuhlinger G, Pezawas L, Aschauer HN, Kasper S. Buprenorphine versus methadone maintenance for the treatment of opioid dependence. Addiction. 1999 Sep;94(9):1337-47. doi: 10.1046/j.1360-0443.1999.94913376.x.
PubMed 10615719Jones HE, Kaltenbach K, Heil SH, Stine SM, Coyle MG, Arria AM, O'Grady KE, Selby P, Martin PR, Fischer G. Neonatal abstinence syndrome after methadone or buprenorphine exposure. N Engl J Med. 2010 Dec 9;363(24):2320-31. doi: 10.1056/NEJMoa1005359.
PubMed 21142534Jones ES, Fiellin DA. Women and opioid dependence treatment: office-based versus opioid treatment program-based care? Subst Abus. 2007 Jun;28(2):3-8. doi: 10.1300/J465v28n02_02.
PubMed 19266708Korthuis PT, Gregg J, Rogers WE, McCarty D, Nicolaidis C, Boverman J. Patients' Reasons for Choosing Office-based Buprenorphine: Preference for Patient-Centered Care. J Addict Med. 2010 Dec;4(4):204-10. doi: 10.1097/ADM.0b013e3181cc9610.
PubMed 21170143Hansen HB, Siegel CE, Case BG, Bertollo DN, DiRocco D, Galanter M. Variation in use of buprenorphine and methadone treatment by racial, ethnic, and income characteristics of residential social areas in New York City. J Behav Health Serv Res. 2013 Jul;40(3):367-77. doi: 10.1007/s11414-013-9341-3.
PubMed 23702611Moore BA, Fiellin DA, Barry DT, Sullivan LE, Chawarski MC, O'Connor PG, Schottenfeld RS. Primary care office-based buprenorphine treatment: comparison of heroin and prescription opioid dependent patients. J Gen Intern Med. 2007 Apr;22(4):527-30. doi: 10.1007/s11606-007-0129-0.
PubMed 17372805Fiellin DA, Schottenfeld RS, Cutter CJ, Moore BA, Barry DT, O'Connor PG. Primary care-based buprenorphine taper vs maintenance therapy for prescription opioid dependence: a randomized clinical trial. JAMA Intern Med. 2014 Dec;174(12):1947-54. doi: 10.1001/jamainternmed.2014.5302.
PubMed 25330017Jones ES, Moore BA, Sindelar JL, O'Connor PG, Schottenfeld RS, Fiellin DA. Cost analysis of clinic and office-based treatment of opioid dependence: results with methadone and buprenorphine in clinically stable patients. Drug Alcohol Depend. 2009 Jan 1;99(1-3):132-40. doi: 10.1016/j.drugalcdep.2008.07.013. Epub 2008 Sep 19.
PubMed 18804923Fiellin DA, Kleber H, Trumble-Hejduk JG, McLellan AT, Kosten TR. Consensus statement on office-based treatment of opioid dependence using buprenorphine. J Subst Abuse Treat. 2004 Sep;27(2):153-9. doi: 10.1016/j.jsat.2004.06.005.
PubMed 15450648Stine SM, Heil SH, Kaltenbach K, Martin PR, Coyle MG, Fischer G, Arria AM, Selby P, Jones HE. Characteristics of opioid-using pregnant women who accept or refuse participation in a clinical trial: screening results from the MOTHER study. Am J Drug Alcohol Abuse. 2009;35(6):429-33. doi: 10.3109/00952990903374080.
PubMed 20014912Almario CV, Seligman NS, Dysart KC, Berghella V, Baxter JK. Risk factors for preterm birth among opiate-addicted gravid women in a methadone treatment program. Am J Obstet Gynecol. 2009 Sep;201(3):326.e1-6. doi: 10.1016/j.ajog.2009.05.052. Epub 2009 Jul 24.
PubMed 19631928
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Comparative Effectiveness Clinical Trial of Buprenorphine vs. Methadone for the Treatment of Opioid Dependence in Pregnancy.
- ClinicalTrials.gov ID
- NCT03098407
- Acronym / sponsor ID
- PRO16020403
- Conditions
- Opioid-Related Disorders, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 31 Mar 2017 (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.
The incidence of opioid dependence in pregnancy increased over the last decade from 1.2 to 5.8 per 1,000 hospital births per year.1 While methadone is the current, standard treatment for opioid dependent (OD) pregnant women, buprenorphine recently emerged as an alternative. In a recent clinical trial (MOTHER), buprenorphine was associated with superior neonatal outcomes such as shorter duration of treatment for neonatal abstinence syndrome (NAS) compared to methadone. However, buprenorphine was also associated with greater study discontinuation (33% vs. 18%) and illicit opioid use (33% vs. 23%) compared to methadone. Treatment dropout often leads to relapse and resumption of high-risk behaviors, overshadowing any short-term improvement in neonatal outcomes. Therefore, The goal of this K23 proposal is to conduct a pilot study to establish the feasibility and acceptability of a randomized comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally licensed methadone programs for the treatment of OD pregnant women.
A pilot study is critical to develop the outcome measures, assessment tools and participant tracking techniques necessary for a future, large-scale comparative effectiveness clinical trial. An examination of feasibility and acceptability will also allow use to characterize the subpopulations of OD pregnant women willing to participate in treatment randomization, identify patient and provider characteristics associated with established treatment preferences and inform the development of strategies to improve participation and enhance the generalizability of the future large-scale clinical trial.
Detailed description
Objective:
The goal of this proposal is to conduct a pilot study to establish the feasibility and acceptability of a randomized comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally licensed methadone programs for the treatment of opioid dependent pregnant women.
Specific Aims:
Aim 1: Evaluate the feasibility of conducting a randomized study comparing office-based buprenorphine vs. federally licensed methadone programs for the treatment of OD pregnant women. OD pregnant women (n=50) will be randomized (1:1) to office-based buprenorphine vs. a federally licensed methadone program. Feasibility will be assessed by measuring the proportion of OD pregnant women who are eligible, who enroll, who remain in the study and by the ability to monitor treatment program factors (e.g. compliance with treatment provider/facility visits, counseling sessions, prenatal care visits, social services involvement) and maternal treatment outcomes such as treatment retention, illicit drug use and HIV risk behavior.
Aim 2: Describe the perspectives of OD pregnant women and their providers regarding buprenorphine vs. methadone for the treatment of opioid dependence in pregnancy. Study acceptability will be assessed by conducting qualitative semi-structured interviews with three groups: (1) pilot participants to determine their satisfaction with the assigned treatment program and identify mismatches between treatment program services and participants' needs; (2) prenatal care and opioid treatment providers to identify ways to improve the treatment process in pregnancy and to suggest ideas for care coordination; (3) OD pregnant women who are ineligible or who choose not to participate in the pilot trial will also be asked to participate in an interview to gain a broader perspective of attitudes and perspectives regarding opioid treatment programs in pregnancy.
Aim 3: Identify barriers and facilitators to treatment retention in the postpartum period and identify key functional outcomes relevant to reductions in illicit drug use during pregnancy. Illicit drug use relapse is most common in the immediate postpartum period when stresses associated with motherhood are the greatest. Therefore, pilot participants will be followed at 3, 6, 9 and 12 weeks postpartum to identify barriers and facilitators specific to the postpartum period that may impact treatment retention. The relationship between postpartum treatment retention and maternal functional outcomes will also be explored (e.g. breastfeeding, postpartum depression, motherhood satisfaction, infant custody, employment, and criminality).
Background:
The incidence of opioid dependence in pregnancy increased over the last decade from 1.2 to 5.8 per 1,000 hospital births per year. While methadone is the current, standard treatment for opioid dependent (OD) pregnant women, buprenorphine recently emerged as an alternative. In a recent clinical trial (MOTHER), buprenorphine was associated with superior neonatal outcomes such as shorter duration of treatment for neonatal abstinence syndrome (NAS) compared to methadone. However, buprenorphine was also associated with greater study discontinuation (33% vs. 18%) and illicit opioid use (33% vs. 23%) compared to methadone. Treatment dropout often leads to relapse and resumption of high-risk behaviors, overshadowing any short-term improvement in neonatal outcomes. Therefore, the next research question that emerges is which is the most effective treatment (buprenorphine vs. methadone) for a particular patient during pregnancy?
In clinical settings, differences in maternal characteristics, treatment program structure and patient and provider preferences may surpass the impact of pharmacology on maternal treatment outcomes (treatment retention, illicit drug use, HIV risk behavior). Buprenorphine is dispensed in office-based settings by a variety of providers and with less regulatory oversight than methadone. Methadone is dispensed from federally licensed facilities that often incorporate counseling and support services into treatment protocols. Successful office-based treatment relies on shared power and responsibility, close patient-provider relationships and careful attention to psychosocial co-morbidities. Failure to match patient problem severity to differences in treatment program structure may contribute to adverse maternal outcomes. Therefore, to understand the comparative effectiveness of buprenorphine vs. methadone in pregnancy, the impact of patient problem severity and treatment program structure on maternal (vs. neonatal) outcomes must be compared.
Significance:
Findings from this project will provide the preliminary data to support a comparative effectiveness clinical trial designed to compare the impact of office-based buprenorphine vs. federally licensed methadone programs on maternal treatment and postpartum functional outcomes in OD women. The ultimate goal of this line of research is develop evidence-based clinical guidelines to guide provider decision-making regarding the most effective treatment (buprenorphine vs. methadone) for a particular patient during pregnancy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine Maintenance Treatment | Other | Drug: BuprenorphineBuprenorphine Maintenance Treatment patients will receive instructions regarding a follow-up, outpatient appointment with the Pregnancy Recovery Center at Magee-Womens Hospital, which specializes in Opioid maintenance treatment for pregnant patients, for the next day following enrollment in the study for induction onto buprenorphine maintenance treatment. |
| Methadone Maintenance Treatment | Other | Drug: MethadoneMethadone Maintenance Treatment patients will be immediately admitted to Magee-Womens Hospital for an inpatient induction onto methadone maintenance treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women 18+ years old, with a singleton pregnancy ≤ 28 weeks gestation confirmed by ultrasound, who meet Diagnostic and Statistical Manual-IV criteria for opioid dependence confirmed by urine drug screen (UDS), who are interested in opioid maintenance treatment and plan to receive prenatal care and deliver at Magee Womens Hospital (MWH) will be recruited.
Key exclusion criteria (4 listed)
- (1) active, current dependence on benzodiazepines or alcohol
- (2) acute severe psychiatric condition in need of immediate treatment (e.g. suicidal ideations)
- (3) pending or legal action that could prohibit or interfere with participation (e.g. incarceration)
- (4) current, established treatment with methadone or buprenorphine. Exclusion criteria are based on the Substance Abuse and Mental Health Services Administration (SAMHSA) recommendations for office-based buprenorphine use.
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 |
|---|---|---|
| BuprenorphineThis is a pilot study to establish the feasibility and acceptability of a randomized comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally licensed methadone treatment programs for OD pregnant women. | Drug | Buprenorphine Maintenance Treatment |
| MethadoneThis is a pilot study to establish the feasibility and acceptability of a randomized comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally licensed methadone treatment programs for OD pregnant women. | Drug | Methadone Maintenance Treatment |
Primary outcome
Number of participants who are recruited, enrolled, retained, and who complete the study.
Time frame: 12 Months
evaluate a minimum of 9 OD pregnant women per month for possible participation and enrollment, randomize a minimum of 4 participants per month to office-based buprenorphine (PRC) or methadone treatment facility (NATP) for a total of 50 participants over a 12 month enrollment period, retain ≥ 80% of randomized participants until 12 weeks postpartum, and maintain < 5% of incomplete data.
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 9 Nov 2020.
- Background: PubMed 22546608Patrick SW, Schumacher RE, Benneyworth BD, Krans EE, McAllister JM, Davis MM. Neonatal abstinence syndrome and associated health care expenditures: United States, 2000-2009. JAMA. 2012 May 9;307(18):1934-40. doi: 10.1001/jama.2012.3951. Epub 2012 Apr 30.
- Background: PubMed 25622120Meyer MC, Johnston AM, Crocker AM, Heil SH. Methadone and buprenorphine for opioid dependence during pregnancy: a retrospective cohort study. J Addict Med. 2015 Mar-Apr;9(2):81-6. doi: 10.1097/ADM.0000000000000092.
- Background: PubMed 23106923Jones HE, Heil SH, Baewert A, Arria AM, Kaltenbach K, Martin PR, Coyle MG, Selby P, Stine SM, Fischer G. Buprenorphine treatment of opioid-dependent pregnant women: a comprehensive review. Addiction. 2012 Nov;107 Suppl 1(0 1):5-27. doi: 10.1111/j.1360-0443.2012.04035.x.
- Background: PubMed 21535372Goodman D. Buprenorphine for the treatment of perinatal opioid dependence: pharmacology and implications for antepartum, intrapartum, and postpartum care. J Midwifery Womens Health. 2011 May-Jun;56(3):240-7. doi: 10.1111/j.1542-2011.2011.00049.x.
- Background: PubMed 10615719Fischer G, Gombas W, Eder H, Jagsch R, Peternell A, Stuhlinger G, Pezawas L, Aschauer HN, Kasper S. Buprenorphine versus methadone maintenance for the treatment of opioid dependence. Addiction. 1999 Sep;94(9):1337-47. doi: 10.1046/j.1360-0443.1999.94913376.x.
- Background: PubMed 21142534Jones HE, Kaltenbach K, Heil SH, Stine SM, Coyle MG, Arria AM, O'Grady KE, Selby P, Martin PR, Fischer G. Neonatal abstinence syndrome after methadone or buprenorphine exposure. N Engl J Med. 2010 Dec 9;363(24):2320-31. doi: 10.1056/NEJMoa1005359.
- Background: PubMed 19266708Jones ES, Fiellin DA. Women and opioid dependence treatment: office-based versus opioid treatment program-based care? Subst Abus. 2007 Jun;28(2):3-8. doi: 10.1300/J465v28n02_02.
- Background: PubMed 21170143Korthuis PT, Gregg J, Rogers WE, McCarty D, Nicolaidis C, Boverman J. Patients' Reasons for Choosing Office-based Buprenorphine: Preference for Patient-Centered Care. J Addict Med. 2010 Dec;4(4):204-10. doi: 10.1097/ADM.0b013e3181cc9610.
- Background: PubMed 23702611Hansen HB, Siegel CE, Case BG, Bertollo DN, DiRocco D, Galanter M. Variation in use of buprenorphine and methadone treatment by racial, ethnic, and income characteristics of residential social areas in New York City. J Behav Health Serv Res. 2013 Jul;40(3):367-77. doi: 10.1007/s11414-013-9341-3.
- Background: PubMed 17372805Moore BA, Fiellin DA, Barry DT, Sullivan LE, Chawarski MC, O'Connor PG, Schottenfeld RS. Primary care office-based buprenorphine treatment: comparison of heroin and prescription opioid dependent patients. J Gen Intern Med. 2007 Apr;22(4):527-30. doi: 10.1007/s11606-007-0129-0.
- Background: PubMed 25330017Fiellin DA, Schottenfeld RS, Cutter CJ, Moore BA, Barry DT, O'Connor PG. Primary care-based buprenorphine taper vs maintenance therapy for prescription opioid dependence: a randomized clinical trial. JAMA Intern Med. 2014 Dec;174(12):1947-54. doi: 10.1001/jamainternmed.2014.5302.
- Background: PubMed 18804923Jones ES, Moore BA, Sindelar JL, O'Connor PG, Schottenfeld RS, Fiellin DA. Cost analysis of clinic and office-based treatment of opioid dependence: results with methadone and buprenorphine in clinically stable patients. Drug Alcohol Depend. 2009 Jan 1;99(1-3):132-40. doi: 10.1016/j.drugalcdep.2008.07.013. Epub 2008 Sep 19.
- 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.
Elizabeth E Krans, MD, MSc principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buprenorphine and Methadone in people with Opioid-Related Disorders and Pregnancy, run by University of Pittsburgh at 1 site 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 1 inclusion and 4 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 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Number of participants who are recruited, enrolled, retained, and who complete the study. (time frame: 12 Months). 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 NCT03098407, which also lists 61 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 Nov 2020.