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Feasibility and Safety of Extended-Release Naltrexone Treatment of Opioid and Alcohol Use Disorder in HIV Clinics: A Pilot/Feasibility Randomized Trial.

Addiction 2017;112(6):1036-1044. [doi: 10.1111/add.13753]

P. Todd Korthuis, MD, MPH (Oregon Healty & Science University, WS Node), Paula J. Lum, MD, MPH (University of California, San Francisco, WS Node), Pamela Vergara-Rodriguez, MD (CORE Center, OV Node), Keith Ahamad, MD (University of British Columbia, WS Node), Evan Wood, MD, PhD (University of British Columbia, WS Node), Lynn E. Kunkel, MD (Oregon Health & Science University, WS Node), Neal L. Oden, PhD (EMMES Corporation, CTN DSC), Robert Lindblad, MD (EMMES Corporation, CTN CCC), James L. Sorensen, PhD (University of California, San Francisco, WS Node), Virgilio Arenas, MD (CORE Center, OV Node), Doan Ha, MPH, DrPH (Oregon Health & Science University, WS Node), Raul N. Mandler, MD (NIDA Center for the Clinical Trials Network), Dennis McCarty, PhD (Oregon Health & Science University, WS Node).

This is the Primary Outcomes Article for CTN-0055. HIV-infected persons 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. This non-blinded, randomized trial, CTN-0055 (CHOICES), compared 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. The study was set in HIV primary care clinics in Vancouver, British Columbia, and Chicago, Illinois. Fifty-one HIV-infected patients seeking treatment for opioid use disorder (OUD, n=16), alcohol use disorder (AUD, n=27), or both (n=8) were randomized. 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 pcr < 200 copies/mL), and safety.

Results found that two-thirds (68%) of participants assigned to XR-NTX initiated treatment, and 88% of these were retained on XR-NTX at 16 weeks. By 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 19 to 10 for TAU (n=12) and from 18-13 for XR-NTX (n=10). Mean heavy drinking days decreased from 18 to 7 for TAU (n=11) and 13 to 6 for XR-NTX (n=12). 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 1 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. The findings underscore the need for a multi-site trial to test the potential of XR-NTX for improving engagement in the HIV care continuum. Use of long-acting addiction pharmacotherapies such as XR-NTX may improve the capacity for HIV-infected patients with substance use disorders to better engage in HIV treatment and close gaps in the HIV care continuum. (Article (Peer-Reviewed), PDF, English, 2017)

Keywords: Alcohol | Co-occurring disorders | CTN primary outcomes | HIV/AIDS | Naltrexone | Opioid dependence | Pharmacological therapy | Retention - Treatment | Vivitrol | Addiction (journal)

Document No: 1247, PMID: 28061017, PMCID: PMC5408318 (available 6/1/2018).

Submitted by Jack Blaine, MD, NIDA CCTN, 1/6/2017.

Ahamad, Keith mail
Arenas, Virgilio
Ha, Doan mail
Korthuis, P. Todd mail
Kunkel, Lynn E. mail
Lindblad, Robert search mail
Lum, Paula J. mail
Mandler, Raul N. mail
McCarty, Dennis search mail
Oden, Neal L. mail
Sorensen, James L. mail
Vergara-Rodriguez, Pamela mail
Wood, Evan mail
NIDA-CTN-0055 www
Western States (Lead) www
Ohio Valley www
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Supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute.
The materials on this site have neither been created nor reviewed by NIDA.
Updated 6/2017 --
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