"Government agencies and professional societies,* including the American Society of Addiction Medicine, have recommended against using AAROD in clinical settings (9). There is insufficient knowledge regarding how widely AAROD is used in the United States and the frequency of AAROD-associated adverse events in community practice settings. At least seven deaths occurred following AAROD among 2,350 procedures performed in one practice during 1995–1999.†

Heroin
"• Heroin was reported as the primary substance of abuse for 26 percent of TEDS admissions aged 12 and older in 2015 [Table 1.1b].

"• Sixty-seven percent of primary heroin admissions were non-Hispanic White (41 percent were males and 26 percent were females). Non-Hispanic Blacks made up 14 percent (9 percent were males and 5 percent were females). Admissions of Puerto Rican origin made up 7 percent of primary heroin admissions (6 percent were males and 1 percent were females) [Table 2.3b]. See Chapter 3 for additional data on heroin admissions.

"For more than 45 years, research has confirmed that opioid agonist therapy (ie, methadone hydrochloride) is a highly effective treatment for opioid addiction provided outside primary care.^4-6"

"However, one problem markedly reduces naltrexone’s efficacy and has limited its use for treating heroin and other forms of opioid dependence worldwide: patients often do not like it and do not take it on a daily basis.

"Findings from a 24-week randomized controlled trial comparing extended-release injectable naltrexone (Vivitrol, Alkermes) to placebo in individuals with current opioid dependence have been considered in the recent indication for extended-release injectable naltrexone for the treatment of opioid dependence. In this trial, subjects having completed 30-day detoxification were recruited from 13 sites in Russia received either 380 mg intramuscular injections of extended-release naltrexone (n = 126) or placebo injection (n = 124) every 4 weeks for 24 weeks.

"A randomized, double-blind, placebo-controlled trial examined the treatment efficacy of long-acting injectable naltrexone (Naltrel, DrugAbuse Sciences) for relapse prevention in 60 heroin-dependent i­ndividuals. Patients were stratified by sex and years of heroin use and randomized to receive placebo, 192 mg, or 384 mg of long-acting naltrexone intramuscular injections dosed on weeks 1 and 5. In addition to ­medication, patients received relapse prevention therapy and had urine monitored for drug relapse.

"In order to overcome the issues of poor t­reatment adherence with oral naltrexone, a number of sustained-release implants have been developed internationally for use in alcohol and opioid dependence. A non-randomized retrospective review examined two types of sustained-release naltrexone implants, oral naltrexone, and historical controls revealed a significant difference between immediate and sustained-­release injectable naltrexone in individuals opioid-free 12 months after initiating treatment.

"Despite the ease of outpatient dosing and its ability to effectively block the euphoric effects of ?-opioid agonists, naltrexone has had limited success for relapse prevention when compared with maintenance t­herapy with methadone or buprenorphine.

"Originally approved for use in the treatment of opioid dependence by the United States Food and Drug administration (FDA) in 1984, naltrexone is a competitive ?-opioid receptor antagonist with negligible agonist effects, blocking euphoric and physiological effects of opioid agonists.^11,12 Naltrexone does not cause the development of dependence or tolerance over time, and dosing cessation does not result in withdrawal.¹³

"There is evidence from published and unpublished observational studies that opiate substitution treatment is associated with an average 54% reduction in the risk of new HIV infection among people who inject drugs. There is weak evidence to suggest that greater benefit might be associated with longer measured duration of exposure to opiate substitution treatment.