heroin for about methadone (5–24 wk) 10 years. qwk reported and may be opioid use biased. Excluded on the pregnancy, Only 45.6% of timeline breastfeeding, all patients follow-back significant medical completed the (TLFB) conditions, study, with a survey. naloxone relatively challenge; hepatic SOMs: large absolute failure; hx of reported diff of 15.3% AIDS-indicator opioid-free in completion disease; active days on rates between hepatitis or AST or TLFB; tx groups ALT >3x ULN; opioid favoring NTX intolerance or craving IMI. hypersensitivity to scores External naltrexone, (VAS Validity to VA: carmellose, or Possible in number of some pts, days of particularly in psychosis; bipolar retention; young age, disorder; major relapse to male, HIV+, depressive physiologic HCV+, disorder with opioid without suicidal ideation; dependence serious active present (naloxone medical or dependence on challenge psychiatric substances other test). illnesses, and than opioids or Other: HIV not on the heroin, including risk; SF-36; excluded alcohol; positive EuroQol-5 Diffs in urine test for general country and cocaine or health; CGI. health care amphetamines; system. Study naltrexone use Safety: authors within past 6 mo. TEAEs; VS; suggested labs Prohibited drugs: that ER-NTX including naltrexone, may be a tx to LFTs; buprenorphine, consider in injection levacetylmethadol, those whose site; EKGs methadone, other employment prescription prohibits opioids, opioid use, antipsychotics, those with a anticonvulsants, relatively antidepressants, recent and anxiolytics. addiction to opioids, and Permitted those who wish to anticonvulsants if secure their dosing was stable; recovery after and short-acting a successful insomnia drugs, course of such as zopiclone, agonist as required. therapy.
heroin for about 10 years. Excluded pregnancy, breastfeeding, significant medical conditions, naloxone challenge; hepatic failure; hx of AIDS-indicator disease; active hepatitis or AST or ALT >3x ULN; intolerance or hypersensitivity to naltrexone, carmellose, or psychosis; bipolar disorder; major depressive disorder with suicidal ideation; present dependence on substances other than opioids or heroin, including alcohol; positive urine test for cocaine or amphetamines; naltrexone use within past 6 mo. Prohibited drugs: naltrexone, buprenorphine, levacetylmethadol, methadone, other prescription opioids, antipsychotics, anticonvulsants, antidepressants, and anxiolytics. Permitted anticonvulsants if dosing was stable; and short-acting insomnia drugs, such as zopiclone, as required. methadone qwk opioid use on the timeline follow-back (TLFB) survey. SOMs: opioid-free days on TLFB; opioid craving scores (VAS number of days of retention; relapse to physiologic opioid dependence (naloxone challenge test). Other: HIV risk; SF-36; EuroQol-5 general health; CGI. Safety: TEAEs; VS; labs including LFTs; injection site; EKGs (5–24 wk) and may be biased. Only 45.6% of all patients completed the study, with a relatively large absolute diff of 15.3% in completion rates between tx groups favoring NTX IMI. External Validity to VA: Possible in some pts, particularly in young age, male, HIV+, HCV+, without serious active medical or psychiatric illnesses, and not on the excluded Diffs in country and health care system. Study authors suggested that ER-NTX may be a tx to consider in those whose employment prohibits opioid use, those with a relatively recent addiction to opioids, and those who wish to secure their recovery after a successful course of agonist therapy. reported reported
Naltrexone_ER_Susp_Inj_Monograph_Addendum_2014.docx