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Program Profile: Naltrexone for Federal Probationers

Evidence Rating: Promising - One study Promising - One study

Date: This profile was posted on June 13, 2011

Program Summary

A medication used in the treatment of opioid addiction, which works by antagonizing opioid receptors and blocking the effects of opiates consumed by addicts (usually in the form of heroin). The program is rated Promising. There was significantly less opioid use among the experimental group. The experimental group receiving naltrexone was significantly less likely to be reincarcerated.

Program Description

Program Goals

Naltrexone hydrochloride is a medication used in the treatment of opioid addiction. Approved by the Food and Drug Administration in 1985 for use in opioid dependence, the medication works by antagonizing opioid receptors and blocking the effects of opiates (usually in the form of heroin) consumed by addicts. Naltrexone can help patients avoid relapse in the early stages of detoxification treatment without increasing the severity of withdrawal symptoms. The medication is usually prescribed as part of a drug treatment program that includes counseling and other support services.

 

Program Components

A typical treatment regimen will vary by patient, depending on the extent of the opioid addiction. Some patients are required to take daily doses (usually 50mg per day), while other patients receive higher doses (100mg to 150mg) two or three times each week. Once a patient has detoxified from opioids and has stabilized on naltrexone, regular opioid drug use has little if any effect. Patients discover that intake of even large doses of opioids no longer produces the same effects as it once did. Opioid-seeking behavior can be reduced as long as patients continue to take naltrexone as prescribed, especially in conjunction with other drug treatment approaches, such as individual counseling sessions.

 

Despite the potential positive effects of naltrexone, the treatment is not always readily accepted by individuals with opioid addiction. Also, patient noncompliance with daily oral dosing protocols can hinder the effectiveness of the medication. There are several reasons these populations may be reluctant to try naltrexone. First, naltrexone treatment requires abstinence from all opioid use, and an individual must remain opioid free for at least 5 days. Many opioid addicts are unable to successfully detoxify and control their drug use for that length of time. Also, naltrexone, unlike other medications for opioid dependence such as methadone, has no opioid agonist effects and produces no physiological dependence. Thus, naltrexone does not provide patients with a positive mood state, and patients can stop taking the medication at any time without experiencing withdrawal symptoms.

 

Additional Information

Because noncompliance with daily or weekly naltrexone treatment is such an issue, some recent clinical research has begun to explore the effects of using naltrexone implants with opioid-dependent patients. The implants, which are either inserted or injected into patients, allow for sustained-release preparations of naltrexone medication over a period of months, instead of days, thereby reducing the number of subsequent treatment visits. The research is still preliminary, and the FDA has only recently approved use of an extended-release form of naltrexone administered by intramuscular injection once a month (FDA News Release 2010).

 

Though there have been numerous studies examining the efficacy of naltrexone treatment on opioid-addicted populations, there have been only a few studies that have specifically examined treatment effects on criminal justice–involved populations (Patapis and Nordstrom 2006).

Evaluation Outcomes

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Study 1

In the study by Cornish and colleagues (1997), only 52 percent of the experimental group remained on naltrexone for the entire study period. The highest rate of dropout occurred during the first month of the study (the majority occurred within the first week). Thirty-three percent of the control group was retained through the entire study. The retention rate for the experimental group was not significantly higher than the control group.

 

Opioid Use

Study participants receiving naltrexone had an average of 8 percent opioid-positive specimens, while members of the control group averaged 30 percent positive specimens. Overall drug use in the control group was higher than the experimental group. However, the only significant difference was in use of opioids (8 percent of the experimental group, compared with 30 percent of the control group). Cocaine use among both groups remained high (33 percent of the experimental group and 49 percent of the control group), but the difference was not significant.

 

Reincarceration

The experimental group receiving naltrexone was significantly less likely to be reincarcerated. Among the experimental group, 26 percent were reincarcerated for a probation violation, compared with 56 percent of the control group.

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Evaluation Methodology

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Study 1

A study from Cornish and colleagues (1997) looked at the ability of naltrexone therapy to reduce opioid use and reincarceration of Federal probationers with a history of opioid addiction. The study sample included individuals who had been assigned to serve a minimum of 2 years on Federal probation or parole. They were being supervised by probation officers of the Substance Abuse Program of the United States Federal Probation Office in Philadelphia, Pa. Sixty-eight probationers volunteered to participate in the study; 51 of these probationers completed the consent, initial evaluation, and induction into the study. The 51 enrolled subjects were randomly assigned in a 2:1 ratio to the experimental group (n= 34) or the control group (n= 17). The sample was 90 percent male, and 62 percent African American, 24 percent white, and 14 percent Latino, with an average age of 39 years. There were no statistically significant differences between the two groups.

 

Control group members were required to attend three orientation and counseling sessions each week during the first 2 weeks of the study. The sessions concentrated on obtaining drug use and treatment histories and provided information on AIDS education and risk reduction. Control group members also provided a monitored urine specimen and breathalyzer reading twice a week. During weeks 3 through 24 of the study, the control group saw their probation officer twice a week, and one of the two visits was randomly selected for group members to provide a monitored urine specimen and breathalyzer reading.

 

The experimental group received naltrexone treatment. Two days before the first scheduled medication visit, group members provided a supervised urine sample to ensure they were not actively using opioids. Group members who were found to be opioid dependent were offered detoxification at an inpatient facility. On the first day, a standard 0.8mg naloxone challenge (intravenous or subcutaneous) was administered to verify the absence of physical dependence on opioids. Experimental group members who had a positive naloxone challenge were asked to repeat the test 24 to 48 hours later. When the naloxone challenge was negative, group members received a 25mg oral dose of naltrexone. If no clinical evidence of opioid withdrawal manifested after 1 hour of observation, they were prescribed naltrexone 25mg daily for 2 days, followed by 50mg daily for 3 days. About 1 week after initiation, they were stabilized on a naltrexone regimen of 100mg on Tuesdays and 150mg on Fridays. This dosage and dispensing regimen was maintained throughout the study period. Once a week the experimental group members provided a directly observed urine sample and a breathalyzer reading from research staff (though these results were not shared with the probation office, and the probation office did not share its results with the research staff). All urine samples were analyzed for 10 substances, including opioids, amphetamines, cocaine, benzodiazepines, barbiturates, and various other sedatives, using the enzyme multiplied immunoassay technique. Study retention was determined by counting the number of weeks that group members remained in compliance with the treatment protocol. Those who had 2 consecutive weeks of absences were dropped from the study.

 

The study lasted 6 months, which was consistent with naltrexone treatment protocols of earlier clinical studies. Study participants were scheduled to meet with their probation/parole officer weekly for the first 6 months. Medication visits were scheduled for twice a week, with one visit scheduled to occur the same day as a probation office visit (the treatment office was across the hall from the probation office).

 

The outcomes of interests included opioid use, which was measured by positive urine samples, and reincarceration rates. The study used t–tests and chi-square tests to determine the significance of the differences between the experimental and control group outcomes.

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Cost

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There is no cost information available for this program.
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Evidence-Base (Studies Reviewed)

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These sources were used in the development of the program profile:

Study 1

Cornish, James W., David Metzger, George E. Woody, David Wilson, A. Thomas McLellan, Barry Vandergrift, and Charles P. O’Brien. 1997. “Naltrexone Pharmacotherapy for Opioid Dependent Federal Probationers.” Journal of Substance Abuse Treatment 14(6):529–34.


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Additional References

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These sources were used in the development of the program profile:

Coviello, Donna M., James W. Cornish, Kevin G. Lynch, Arthur I. Alterman, and Charles P. O’Brien. 2010. “A Randomized Trial of Oral Naltrexone for Treating Opioid-Dependent Offenders.” American Journal on Addictions 19:422–32.

Coviello, Donna M., James W. Cornish, Kevin G. Lynch, Tamara Y. Boney, Cynthia A. Clark, Joshua D. Lee, Peter D. Friedmann, Edward V. Nunes, Timothy W. Kinlock, Michael S. Gordon, Robert P. Schwartz, Elie S. Nuwayser, and Charles P. O’Brien. 2012. “A Multisite Pilot Study of Extended-Release Injectable Naltrexone Treatment for Previously Opioid-Dependent Parolees and Probationers.” Substance Abuse 33:48–59.

Food and Drug Administration (FDA) News Release. 2010. “FDA Approves Injectable Drug to Treat Opioid-Dependent Patients.” Oct. 12, 2010.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm229109.htm

Foster, John, Colin Brewer, and Terry Steele. 2003. “Naltrexone Implants Can Completely Prevent Early (1 Month) Relapse After Opiate Detoxification: A Pilot Study of Two Cohorts Totaling 101 Patients With a Note on Naltrexone Blood Levels.” Addiction Biology 8:211–17.

Hulse, Gary K., Noella Morris, Diane Arnold–Reed, and Robert J. Tait. 2009. “Improving Clinical Outcomes in Treating Heroin Dependence: Randomized, Controlled Trial of Oral and Implant Naltrexone.” Archives of General Psychiatry 66(10):1108–15.

Patapis, Nicholas S., and Benjamin R. Nordstrom. 2006. “Research on Naltrexone in the Criminal Justice System.” Journal of Substance Abuse Treatment 31:113–15.
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Related Practices

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Following are CrimeSolutions.gov-rated practices that are related to this program:

Opiate Maintenance Therapy for Dual Heroin–Cocaine Abusers
A medication-assisted treatment for opioid dependence, including methadone, buprenorphine, and Levo-Alpha-Acetymethadol (LAAM). The overall goals are to help opioid-addicted patients alleviate withdrawal symptoms, reduce or suppress opiate cravings, and reduce the illicit use of opioids (such as heroin). The practice is rated Effective for achieving higher sustained heroin abstinence for dual heroin–cocaine abusers, but No Effects for cocaine abstinence for dual abusers.

Evidence Ratings for Outcomes:
Effective - One Meta-Analysis Drugs & Substance Abuse - Heroin/opioids
No Effects - One Meta-Analysis Drugs & Substance Abuse - Cocaine/crack cocaine
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Program Snapshot

Age: 18+

Gender: Both

Race/Ethnicity: Black, Hispanic, White

Geography: Suburban, Urban

Setting (Delivery): Inpatient/Outpatient, Other Community Setting

Program Type: Alcohol and Drug Therapy/Treatment, Aftercare/Reentry, Individual Therapy, Probation/Parole Services

Targeted Population: Alcohol and Other Drug (AOD) Offenders

Current Program Status: Active

Researcher:
David S. Metzger
Director
HIV Prevention Research Division, University of Pennsylvania, Department of Psychiatry
3535 Market Street, Suite 4000
Philadelphia PA 19104
Phone: 215.746.7377
Email