Buprenorphine: FDA-Approved Medication for Opioid Use Disorder

Target Population

Buprenorphine MOUD is designed for individuals who have an opioid use disorder.

Dosage

Buprenorphine MOUD dosage varies by individual and mode of administration. Duration is based on individual needs. The frequency of counseling and social support services varies based on individual needs.

Location/Delivery Setting

Location/Delivery Settings Observed in the Research

• Mental Health Center, Treatment Center, Therapist Office
• Hospital/Medical Center

Program or Service Documentation

Book/Manual/Available documentation used for review

Substance Abuse and Mental Health Services Administration (SAMHSA). (2021). Medications for opioid use disorder: For healthcare and addiction professionals, policymakers, patients, and families (HHS Publication No. PEP21-02-01-002) in conjunction with labeling for FDA-approved buprenorphine products.

Note: The details on Dosage; Location; Education, Certifications, and Training; Other Supporting Materials; and For More Information sections above are provided to website users for informational purposes only. This information is not exhaustive and may be subject to change.

Results of Search and Review	Number of Studies Identified and Reviewed for Buprenorphine: FDA-Approved Medication for Opioid Use Disorder
Identified in Search	2
Eligible for Review	2
Rated High	0
Rated Moderate	2
Rated Low	0
Reviewed Only for Risk of Harm	0

Outcome	Effect Size	95% Confidence Interval	Implied Percentile Effect	N of Studies (Findings)	N of Participants	Summary of Findings
Child well-being: Physical development and health	0.46	[0.12, 0.81]	17	1 (8)	131	Favorable: 4 No Effect: 4 Unfavorable: 0
Adult well-being: Parent/caregiver substance use	-0.13	[-0.30, 0.05]	-5	2 (7)	924	Favorable: 0 No Effect: 4 Unfavorable: 3
Adult well-being: Parent/caregiver criminal behavior	-0.03	[-0.27, 0.21]	-1	1 (10)	303	Favorable: 0 No Effect: 10 Unfavorable: 0
Adult well-being: Parent/caregiver physical health	0.40	[0.16, 0.65]	15	2 (7)	1211	Favorable: 2 No Effect: 5 Unfavorable: 0

Note: For the effect sizes and implied percentile effects reported in the table, a positive number favors the intervention condition and a negative number favors the comparison condition. A range of comparison conditions, including no intervention, minimal intervention, placebo or attention, treatment as usual, and head-to-head comparison conditions are eligible for review (see Section 4.1.7 of the Handbook Version 2.0). Different types of comparison conditions may affect the magnitude of the effect sizes across studies. For example, an intervention compared to a no treatment comparison condition may produce a larger effect size than the same intervention compared to another intervention because the other intervention may itself be effective. The effect sizes shown may be derived from samples that overlap across studies. See the Individual Study Findings table for information about the specific comparison conditions used in each study and the Studies Reviewed section for information about any overlapping samples. The effect sizes presented here are provided for informational purposes only and are not used in determining a program or service rating. Effect sizes for some outcomes were not able to be calculated by the Prevention Services Clearinghouse.

Outcome	Effect Size	Implied Percentile Effect	Months after treatment when outcome measured	Number of Participants
Child well-being: Physical development and health
Study 15758 - Buprenorphine MOUD vs. Methadone Maintenance Therapy MOUD (Jones, 2010)
Treated for Neonatal Abstinence Syndrome (%)	0.24	9	0	129
Neonatal Abstinence Syndrome Peak Score	Favorable *	not calculated	0	129
Infant's Head Circumference (cm)	Favorable *	not calculated	0	130
Weight at Birth (g)	Favorable *	not calculated	0	131
Length at Birth (cm)	Favorable *	not calculated	0	130
Preterm Birth (< 37 Weeks) (%)	0.69	25	0	131
Apgar Score: 1 Minute	Null	not calculated	0	131
Apgar Score: 5 Minute	Null	not calculated	0	131
Adult well-being: Parent/caregiver substance use
Study 15757 - Buprenorphine MOUD/Naloxone vs. Methadone Maintenance Therapy MOUD (Hser, 2016)
Number of Days of Other Opiates/Analgesics Use in Past 30 Days	-0.07	-2	48	795
Number of Days of Heroin Use in Past 30 Days	-0.05	-2	48	795
Positive Urine Test on Heroin or Opiate Use (%)	-0.20 *	-7	48	795
Positive Opioid Urine Test at Follow-up or Any Self-Reported Opioid Use in Past 30 Days (%)	-0.15 *	-6	48	795
Any Use of Other Opiates/Analgesics in Past 30 Days (%)	-0.21 *	-8	48	795
Any Heroin Use in Past 30 Days (%)	-0.08	-3	48	795
Study 15758 - Buprenorphine MOUD vs. Methadone Maintenance Therapy MOUD (Jones, 2010)
Positive Drug Screen at Delivery (%)	0.35	13	0	129
Adult well-being: Parent/caregiver criminal behavior
Study 15757 - Buprenorphine MOUD/Naloxone vs. Methadone Maintenance Therapy MOUD (California Jail Administrative Data Sample) (Evans, 2019)
Ever Arrested in Years 1 to 5 (%)	-0.06	-2	54	303
Number of Arrests in Years 1 to 5	-0.06	-2	54	303
Number of Drug-Related Arrests in Years 1 to 5	-0.06	-2	54	303
Number of Property Arrests in Years 1 to 5	0.13	5	54	303
Number of Violent Offense Arrests in Years 1 to 5	0.06	2	54	303
Number of Other Offense Arrests in Years 1 to 5	-0.22	-8	54	303
Ever Incarcerated in Years 1 to 5 (%)	0.01	0	54	303
Number of Misdemeanor Offense Arrests in Years 1 to 5	-0.05	-2	54	303
Number of Felony Offense Arrests in Years 1 to 5	-0.04	-1	54	303
Number of Moderate Offense Arrests in Years 1 to 5	-0.05	-2	54	303
Adult well-being: Parent/caregiver physical health
Study 15757 - Buprenorphine MOUD/Naloxone vs. Methadone Maintenance Therapy MOUD (Administrative Data Sample) (Hser, 2016)
Mortality (%)	0.34 *	13	66	1080
Time to Mortality (Survival Analysis)	Null	not calculated	66	1080
Study 15758 - Buprenorphine MOUD vs. Methadone Maintenance Therapy MOUD (Jones, 2010)
Maternal Cesarean Section (%)	0.22	8	0	131
Maternal Weight Gain (kg)	Null	not calculated	0	125
Abnormal Fetal Presentation During Delivery (%)	0.68	25	0	129
Medical Complications at Delivery (%)	0.51 *	19	0	131
Number of Prenatal Obstetrical Visits	Null	not calculated	0	131

*p <.05

Note: For the effect sizes and implied percentile effects reported in the table, a positive number favors the intervention condition and a negative number favors the comparison condition. Effect sizes and implied percentile effects were calculated by the Prevention Services Clearinghouse as described in the Handbook of Standards and Procedures, Version 2.0, Sections 6.4 and 6.5 and may not align with effect sizes reported in individual publications. The Prevention Services Clearinghouse uses information reported in study documents and, when necessary, information provided by study authors in response to author queries to assign study ratings and calculate effect sizes (see Section 8.4.2 in the Handbook of Standards and Procedures, Version 2.0). The Prevention Services Clearinghouse typically relies on study-reported p-values to form the basis of the assessment of statistical significance for a finding, but will perform its own statistical test of a finding using any available information in study documents or author queries, as needed (see Section 6.3 in the Handbook of Standards and Procedures, Version 2.0). As a result, the effect sizes and statistical significance reported in the table may not align with the estimates as they are reported in study documents. Effect sizes for some outcomes were not able to be calculated by the Prevention Services Clearinghouse.

Only publications with eligible contrasts that met design and execution standards are included in the individual study findings table.

Full citations for the studies shown in the table are available in the "Studies Reviewed" section.

The participant characteristics display is an initial version. We encourage those interested in providing feedback to send suggestions to preventionservices@abtglobal.com.

The table below displays locations, the year, and participant demographics for studies that received moderate or high ratings on design and execution and that reported the information. Participant characteristics for studies with more than one intervention versus comparison group pair that received moderate or high ratings are shown separately in the table. Please note, the information presented here uses terminology directly from the study documents, when available. Studies that received moderate or high ratings on design and execution that did not include relevant participant demographic information would not be represented in this table.

For more information on how Clearinghouse reviewers record the information in the table, please see our Resource Guide on Study Participant Characteristics and Settings.

Characteristics of the Participants in the Studies with Moderate or High Ratings
Study Location	Study Year	Demographic Characteristics	Populations of Interest*	Household Socioeconomic Status
Study 15758 - Buprenorphine MOUD vs. Methadone Maintenance Therapy MOUD
Characteristics of the Adults, Parents, or Caregivers
Baltimore, MD; Burlington, VT; Detroit, MI; Philadelphia, PA; Providence, RI; Nashville, TN, USA; Vienna, Austria	2005	Average age: 26.6 years 88% White 9% Black 2.8% Other 100% Female	100% Pregnant women	16% Employed
Study 15757 - Buprenorphine MOUD/Naloxone vs. Methadone Maintenance Therapy MOUD
Characteristics of the Adults, Parents, or Caregivers
California, Connecticut, Oregon, Pennsylvania, Washington, USA	2006	Average age: 37.4 years; Age range: 18-55+ years 73% White 11% Hispanic 9% African American 7% Other 66% Male 34% Female	--	--
Study 15757 - Buprenorphine MOUD/Naloxone vs. Methadone Maintenance Therapy MOUD (California Jail Administrative Data Sample)
Characteristics of the Adults, Parents, or Caregivers
California, USA	2006	Average age: 42.4 years; Age range: 18-55+ years 56% White 22% Hispanic 14% Black 8% Other 33% Female	--	--
Study 15757 - Buprenorphine MOUD/Naloxone vs. Methadone Maintenance Therapy MOUD (Administrative Data Sample)
Characteristics of the Adults, Parents, or Caregivers
California, Connecticut, New York, Oregon, Pennsylvania, Washington, USA	2006	Average age: 37.6 years; Age range: 18-55+ years 71% White 12% Hispanic 9% African American 8% Other 67% Male 33% Female	--	--

“--” indicates information not reported in the study.

* The information about disabilities is based on initial coding. For more information on how the Clearinghouse recorded disability information for the initial release, please see our Resource Guide on Study Participant Characteristics and Settings.

Note: Citations for the documents associated with each 5-digit study number shown in the table can be found in the “Studies Reviewed” section below. Study settings and participant demographics are recorded for all studies that received moderate or high ratings on design and execution and that reported the information. Studies that did not report any information about setting or participant demographics are not displayed. For more information on how participant characteristics are recorded, please see our Resource Guide on Study Participant Characteristics and Settings.

Sometimes study results are reported in more than one document, or a single document reports results from multiple studies. Studies are identified below by their Prevention Services Clearinghouse study identification numbers. To receive a rating of supported or well-supported, the favorable evidence for a program or service must have been obtained from research conducted in a usual care or practice setting.

Studies Rated Moderate

Study 15757

Hser, Y.-I., Evans, E., Huang, D., Weiss, R., Saxon, A., Carroll, K. M., Woody, G., Liu, D., Wakim, P., Matthews, A. G., Hatch-Maillette, M., Jelstrom, E., Wiest, K., McLaughlin, P., & Ling, W. (2016). Long-term outcomes after randomization to buprenorphine/naloxone versus methadone in a multi-site trial. Addiction, 111(4), 695-705. https://doi.org/10.1111/add.13238

Saxon, A. J., Ling, W., Hillhouse, M., Thomas, C., Hasson, A., Ang, A., Doraimani, G., Tasissa, G., Lokhnygina, Y., Leimberger, J., Bruce, R. D., McCarthy, J., Wiest, K., McLaughlin, P., Bilangi, R., Cohen, A., Woody, G., & Jacobs, P. (2013). Buprenorphine/Naloxone and methadone effects on laboratory indices of liver health: A randomized trial. Drug and Alcohol Dependence, 128(1-2), 71-76. https://doi.org/10.1016/j.drugalcdep.2012.08.002

Hser, Y.-I., Zhu, Y., Fei, Z., Mooney, L. J., Evans, E. A., Kelleghan, A., Matthews, A., Yoo, C., & Saxon, A. J. (2022). Long-term follow-up assessment of opioid use outcomes among individuals with comorbid mental disorders and opioid use disorder treated with buprenorphine or methadone in a randomized clinical trial. Addiction, 117(1), 151-161. https://doi.org/10.1111/add.15594

Saxon, A. J., Hser, Y.-I., Woody, G., & Ling, W. (2013). Medication-assisted treatment for opioid addiction: Methadone and buprenorphine. Journal of Food and Drug Analysis, 21(4), S69-S72. https://doi.org/10.1016/j.jfda.2013.09.037

Hser, Y.-I., Saxon, A. J., Huang, D., Hasson, A., Thomas, C., Hillhouse, M., Jacobs, P., Teruya, C., McLaughlin, P., Wiest, K., Cohen, A., & Ling, W. (2014). Treatment retention among patients randomized to buprenorphine/naloxone compared to methadone in a multi-site trial. Addiction, 109(1), 79-87. https://doi.org/10.1111/add.12333

Hser, Y.-I., Huang, D., Saxon, A. J., Woody, G., Moskowitz, A. L., Matthews, A. G., & Ling, W. (2017). Distinctive trajectories of opioid use over an extended follow-up of patients in a multisite trial on buprenorphine + naloxone and methadone. Journal of Addiction Medicine, 11(1), 63-69. https://doi.org/10.1097/ADM.0000000000000274

Zhu, Y., Evans, E. A., Mooney, L. J., Saxon, A. J., Kelleghan, A., Yoo, C., & Hser, Y.-I. (2018). Correlates of long-term opioid abstinence after randomization to methadone versus buprenorphine/naloxone in a multi-site trial. Journal of Neuroimmune Pharmacology, 13, 488-497. https://doi.org/10.1007/s11481-018-9801-x

Evans, E. A., Zhu, Y., Yoo, C., Huang, D., & Hser, Y.-I. (2019). Criminal justice outcomes over 5 years after randomization to buprenorphine-naloxone or methadone treatment for opioid use disorder. Addiction, 114(8), 1396-1404. https://doi.org/10.1111/add.14620

Zhu, Y., Mooney, L. J., Yoo, C., Evans, E. A., Kelleghan, A., Saxon, A. J., Curtis, M. E., & Hser, Y.-I. (2021). Psychiatric comorbidity and treatment outcomes in patients with opioid use disorder: Results from a multisite trial of buprenorphine-naloxone and methadone. Drug and Alcohol Dependence, 228, Article 108996. https://doi.org/10.1016/j.drugalcdep.2021.108996

This study was conducted in a usual care or practice setting (Handbook Version 2.0, Section 7.2.2)
Study 15758

Jones, H. E., Kaltenbach, K., Heil, S. H., Stine, S. M., Coyle, M. G., Arria, A. M., O'Grady, K. E., Selby, P., Martin, P. R., & Fischer, G. (2010). Neonatal abstinence syndrome after methadone or buprenorphine exposure. The New England Journal of Medicine, 363(24), 2320-2331. https://doi.org/10.1056/NEJMoa1005359

This study was conducted in a usual care or practice setting (Handbook Version 2.0, Section 7.2.2)

Studies Not Eligible for Review

The studies shown include only those that were reviewed under the Fast-Track Evidence Review Procedure for Food and Drug Administration (FDA)-approved Medications for Opioid Use Disorder (MOUD) as Part of Comprehensive Treatment Plans. Other studies identified are not shown and are not included in the count of studies identified in the Extent of Evidence table, as the review process concluded when review of further studies could not change the program or service rating. For more information, please visit the FAQ on the Fast-Track Procedure.