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Harm reduction with pharmacotherapy for homeless people with alcohol dependence: Protocol for a randomized controlled trial

Collins, S. E. et al.

Contemporary clinical trials. VOL 38; NUMBER 2, ; 2014, 221-234 -- ELSEVIER SCIENCE B.V. AMSTERDAM Part 2; (pages 221-234) -- 2014

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  • Title:
    Harm reduction with pharmacotherapy for homeless people with alcohol dependence: Protocol for a randomized controlled trial
  • Author: Collins, S. E.;
    Saxon, A. J.;
    Duncan, M. H.;
    Smart, B. F.;
    Merrill, J. O.;
    Malone, D. K.;
    Jackson, T. R.;
    Clifasefi, S. L.;
    Joesch, J.;
    Ries, R. K.
  • Found In: Contemporary clinical trials. VOL 38; NUMBER 2, ; 2014, 221-234
  • Journal Title: Contemporary clinical trials.
  • Subjects: Medicine; Biotechnology; Pharmaceutical Chemistry; LCC: DA; Dewey: 616.027
  • Publication Details: ELSEVIER SCIENCE B.V. AMSTERDAM
  • Language: English
  • Abstract: Background: Interventions requiring abstinence from alcohol are neither preferred by nor shown to be highly effective with many homeless individuals with alcohol dependence. It is therefore important to develop lower-threshold, patient-centered interventions for this multimorbid and high-utilizing population. Harm-reduction counseling requires neither abstinence nor use reduction and pairs a compassionate style with patient-driven goal-setting. Extended-release naltrexone (XR-NTX), a monthly injectable formulation of an opioid receptor antagonist, reduces craving and may support achievement of harm-reduction goals. Together, harm-reduction counseling and XR-NTX may support alcohol harm reduction and quality-of-life improvement. Aims: Study aims include testing: a) the relative efficacy of XR-NTX and harm-reduction counseling compared to a community-based, supportive-services-as-usual control, b) theory-based mediators of treatment effects, and c) treatment effects on publicly funded service costs. Methods: This RCT involves four arms: a) XR-NTX+harm-reduction counseling, b) placebo+harm-reduction counseling, c) harm-reduction counseling only, and d) community-based, supportive-services-as-usual control conditions. Participants are currently/formerly homeless, alcohol dependent individuals (N=300). Outcomes include alcohol variables (i.e., craving, quantity/frequency, problems and biomarkers), health-related quality of life, and publicly funded service utilization and associated costs. Mediators include 10-point motivation rulers and the Penn Alcohol Craving Scale. XR-NTX and harm-reduction counseling are administered every 4weeks over the 12-week treatment course. Follow-up assessments are conducted at weeks 24 and 36. Discussion: If found efficacious, XR-NTX and harm-reduction counseling will be well-positioned to support reductions in alcohol-related harm, decreases in costs associated with publicly funded service utilization, and increases in quality of life among homeless, alcohol-dependent individuals.
  • Identifier: Journal ISSN: 1551-7144
  • Publication Date: 2014
  • Physical Description: Electronic
  • Shelfmark(s): 3425.177440
  • UIN: ETOCRN356397392

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