Naltrexone: FDA-Approved Medication for Opioid Use Disorder

Target Population

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

Dosage

Naltrexone 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

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 naltrexone 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 Naltrexone: FDA-Approved Medication for Opioid Use Disorder
Identified in Search	2
Eligible for Review	2
Rated High	2
Rated Moderate	0
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
Adult well-being: Parent/caregiver criminal behavior	0.38	[-0.20, 0.96]	14	2 (16)	359	Favorable: 2 No Effect: 10 Unfavorable: 4

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.

Outcome	Effect Size	Implied Percentile Effect	Months after treatment when outcome measured	Number of Participants
Adult well-being: Parent/caregiver criminal behavior
Study 15772 - Naltrexone MOUD vs. Enhanced Treatment as Usual (Cornish, 1997)
Reincarcerated for Probation Violations (%)	0.77 *	27	0	51
Study 15770 - Naltrexone MOUD vs. Treatment as Usual (Soares, 2019)
Any Parole Violation Arrest (%)	0.25 *	10	13	308
Any Drug Offense Arrest (%)	-0.16	-6	13	308
Any Larceny Arrest (%)	-0.01	0	13	308
Any Other Offense Arrest (%)	-0.06	-2	13	308
Any Assault Arrest (%)	-0.36 *	-14	13	308
Any Trespass Arrest (%)	-0.08	-3	13	308
Any Stolen Property Arrest (%)	-0.12	-4	13	308
Any Weapons Violation Arrest (%)	-1.07 *	-35	13	308
Any Vandalism Arrest (%)	-0.78 *	-28	13	308
Any Burglary Arrest (%)	0.00	0	13	308
Any Disorderly Conduct Arrest (%)	-0.11	-4	13	308
Any DUI Arrest (%)	-0.11	-4	13	308
Any Robbery Arrest (%)	0.03	1	13	308
Any Fraud Arrest (%)	-0.35 *	-13	13	308
Any Arrest (%)	-0.17	-6	13	308

*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.

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 15772 - Naltrexone MOUD vs. Enhanced Treatment as Usual
Characteristics of the Adults, Parents, or Caregivers
Philadelphia, PA	--	Average age: 39 years 62% African American 24% White 14% Latino 90% Male	--	--
Study 15770 - Naltrexone MOUD vs. Treatment as Usual
Characteristics of the Adults, Parents, or Caregivers
Baltimore, MD; Philadelphia, PA; Providence, RI; New York, NY, USA	2009	Average age: 43.8 years 50% Black 27% Hispanic 20% White 85% Male	100% met DSM-IV criteria for opioid dependence	18% Current Employment

“--” 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 High

Study 15772

Cornish, J. W., Metzger, D., Woody, G. E., Wilson, D., McLellan, A. T., Vandergrift, B., & O'Brien, C. P. (1997). Naltrexone pharmacotherapy for opioid dependent federal probationers. Journal of Substance Abuse Treatment, 14(6), 529-534. https://doi.org/10.1016/s0740-5472(97)00020-2

This study was conducted in a usual care or practice setting (Handbook Version 2.0, Section 7.2.2)
Study 15770

Lee, J. D., Friedmann, P. D., Kinlock, T. W., Nunes, E. V., Boney, T. Y., Hoskinson, R. A., Jr, Wilson, D., McDonald, R., Rotrosen, J., Gourevitch, M. N., Gordon, M., Fishman, M., Chen, D. T., Bonnie, R. J., Cornish, J. W., Murphy, S. M., & O'Brien, C. P. (2016). Extended-release naltrexone to prevent opioid relapse in criminal justice offenders. The New England Journal of Medicine, 374(13), 1232-1242. https://doi.org/10.1056/NEJMoa1505409

Soares, W. E., 3rd, Wilson, D., Gordon, M. S., Lee, J. D., Nunes, E. V., O'Brien, C. P., Shroff, M., & Friedmann, P. D. (2019). Incidence of future arrests in adults involved in the criminal justice system with opioid use disorder receiving extended release naltrexone compared to treatment as usual. Drug and Alcohol Dependence, 194, 482-486. https://doi.org/10.1016/j.drugalcdep.2018.10.035

Soares, W. E., 3rd, Wilson, D., Rathlev, N., Lee, J. D., Gordon, M., Nunes, E. V., O'Brien, C. P., & Friedmann, P. D. (2018). Healthcare utilization in adults with opioid dependence receiving extended release naltrexone compared to treatment as usual. Journal of Substance Abuse Treatment, 85, 66-69. https://doi.org/10.1016/j.jsat.2017.05.009

Lee, J. D., Friedmann, P. D., Boney, T. Y., Hoskinson, R. A., Jr, McDonald, R., Gordon, M., Fishman, M., Chen, D. T., Bonnie, R. J., Kinlock, T. W., Nunes, E. V., Cornish, J. W., & O'Brien, C. P. (2015). Extended-release naltrexone to prevent relapse among opioid dependent, criminal justice system involved adults: rationale and design of a randomized controlled effectiveness trial. Contemporary Clinical Trials, 41, 110-117. https://doi.org/10.1016/j.cct.2015.01.005

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 Medication 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.