title: Feasibility and safety of extended-release naltrexone treatment of opioid and alcohol use disorder in HIV clinics: a pilot/feasibility randomized trial.
abstract: OBJECTIVE
  HIV-infected people with substance use disorders are least likely to benefit from advances in HIV treatment. Integration of extended-release naltrexone (XR-NTX) into HIV clinics may increase engagement in the HIV care continuum by decreasing substance use. We aimed to compare (1) XR-NTX treatment initiation, (2) retention and (3) safety of XR-NTX versus treatment as usual (TAU) for treating opioid use disorder (OUD) and/or alcohol use disorder (AUD) in HIV clinics.
  
  
  METHODS
  Non-blinded randomized trial of XR-NTX versus pharmacotherapy TAU.
  
  
  METHODS
  HIV primary care clinics in Vancouver, BC, Canada and Chicago, IL, USA.
  
  
  METHODS
  Fifty-one HIV-infected patients seeking treatment for OUD (n = 16), AUD (n = 27) or both OUD and AUD (n = 8).
  
  
  METHODS
  Primary outcomes were XR-NTX initiation (receipt of first injection within 4 weeks of randomization) and retention at 16 weeks. Secondary outcomes generated point estimates for change in substance use, HIV viral suppression [HIV RNA polymerase chain reaction (pcr) < 200 copies/ml] and safety.
  
  
  RESULTS
  Two-thirds (68%) of participants assigned to XR-NTX initiated treatment, and 88% of these were retained on XR-NTX at 16 weeks. In comparison, 96% of TAU participants initiated treatment, but only 50% were retained on medication at 16 weeks. Mean days of opioid use in past 30 days decreased from 17.3 to 4.1 for TAU and from 20.3 to 7.7 for XR-NTX. Mean heavy drinking days decreased from 15.6 to 5.7 for TAU and 12.5 to 2.8 for XR-NTX. Among those with OUD, HIV suppression improved from 67 to 80% for XR-NTX and 58 to 75% for TAU. XR-NTX was well tolerated, with no precipitated withdrawals and one serious injection-site reaction.
  
  
  CONCLUSIONS
  Extended-release naltrexone (XR-NTX) is feasible and safe for treatment of opioid use disorder and alcohol use disorder in HIV clinics. Treatment initiation appears to be lower and retention greater for XR-NTX compared with treatment as usual (clinicaltrials.gov NCT01908062).
authors.affiliation: Oregon Health and Science University, Portland, OR, USA.
authors.forename: Philip T
authors.initials: PT
authors.lastname: Korthuis
authors.affiliation: University of California, San Francisco, CA, USA.
authors.forename: Paula J
authors.initials: PJ
authors.lastname: Lum
authors.affiliation: Ruth M. Rothstein CORE Center, Chicago, IL, USA.
authors.forename: Pamela
authors.initials: P
authors.lastname: Vergara-Rodriguez
authors.affiliation: British Columbia Centre for Excellence in HIV/AIDS, Vancouver, BC, Canada.|University of British Columbia, Vancouver, BC, Canada.
authors.forename: Keith
authors.initials: K
authors.lastname: Ahamad
authors.affiliation: British Columbia Centre for Excellence in HIV/AIDS, Vancouver, BC, Canada.|University of British Columbia, Vancouver, BC, Canada.
authors.forename: Evan
authors.initials: E
authors.lastname: Wood
authors.affiliation: Oregon Health and Science University, Portland, OR, USA.
authors.forename: Lynn E
authors.initials: LE
authors.lastname: Kunkel
authors.affiliation: EMMES Corporation, Rockville, MD, USA.
authors.forename: Neal L
authors.initials: NL
authors.lastname: Oden
authors.affiliation: EMMES Corporation, Rockville, MD, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Lindblad
authors.affiliation: University of California, San Francisco, CA, USA.
authors.forename: James L
authors.initials: JL
authors.lastname: Sorensen
authors.affiliation: Ruth M. Rothstein CORE Center, Chicago, IL, USA.
authors.forename: Virgilio
authors.initials: V
authors.lastname: Arenas
authors.affiliation: Oregon Health and Science University, Portland, OR, USA.
authors.forename: Doan
authors.initials: D
authors.lastname: Ha
authors.affiliation: National Institutes of Health, National Institute on Drug Abuse, Bethesda, MD, USA.
authors.forename: Raul N
authors.initials: RN
authors.lastname: Mandler
authors.affiliation: Oregon Health and Science University, Portland, OR, USA.
authors.forename: Dennis
authors.initials: D
authors.lastname: McCarty
mesh_terms: D000437:Alcoholism / Q000150:complications / Q000188:drug therapy*; D001955:British Columbia; D002641:Chicago; D003692:Delayed-Action Preparations / Q000009:adverse effects / Q000627:therapeutic use; D005240:Feasibility Studies; D005260:Female; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000009:adverse effects / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D009293:Opioid-Related Disorders / Q000150:complications / Q000188:drug therapy*; D010865:Pilot Projects; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D009292:Narcotic Antagonists; D009271:Naltrexone
keywords: Alcohol; HIV; extended-release naltrexone; injection drug use; opioid-related disorders; randomized clinical trial