Susan E Collins1, Andrew J Saxon2, Mark H Duncan3, Brian F Smart4, Joseph O Merrill5, Daniel K Malone6, T Ron Jackson7, Seema L Clifasefi8, Jutta Joesch9, Richard K Ries10. 1. Department of Psychiatry and Behavioral Sciences, University of Washington - Harborview Medical Center, 325 Ninth Ave Box 359911, Seattle, WA 98195, USA. Electronic address: collinss@uw.edu. 2. VA Puget Sound Health Care System, 1660 S. Columbian Way, Seattle, WA 98108, USA; Department of Psychiatry and Behavioral Sciences, University of Washington, 1100 45th St. Box 354944, Seattle, WA 98195, USA. Electronic address: andrew.saxon@va.gov. 3. Department of Psychiatry and Behavioral Sciences, University of Washington - Harborview Medical Center, 325 Ninth Ave Box 359911, Seattle, WA 98195, USA. Electronic address: mhduncan@uw.edu. 4. Department of Psychiatry and Behavioral Sciences, University of Washington - Harborview Medical Center, 325 Ninth Ave Box 359911, Seattle, WA 98195, USA. Electronic address: smartb@uw.edu. 5. Department of Medicine, University of Washington - Harborview Medical Center, 325 Ninth Ave, Box 359780, Seattle, WA 98195, USA. Electronic address: joem@uw.edu. 6. Downtown Emergency Service Center (DESC), 515 Third Ave, Seattle, WA 98104, USA. Electronic address: dmalone@desc.org. 7. Evergreen Treatment Services - REACH, 1700 Airport Way S, Seattle, WA 98134, USA. Electronic address: ronjack@uw.edu. 8. Department of Psychiatry and Behavioral Sciences, University of Washington, 1100 45th St. Box 354944, Seattle, WA 98195, USA. Electronic address: seemac@uw.edu. 9. Department of Psychiatry and Behavioral Sciences, University of Washington - Harborview Medical Center, 325 Ninth Ave Box 359911, Seattle, WA 98195, USA. Electronic address: Jutta.Joesch@kingcounty.gov. 10. Department of Psychiatry and Behavioral Sciences, University of Washington - Harborview Medical Center, 325 Ninth Ave Box 359911, Seattle, WA 98195, USA. Electronic address: rries@uw.edu.
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.
RCT Entities:
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.
Authors: Helen M Pettinati; Charles P O'Brien; Amanda R Rabinowitz; Shoshana P Wortman; David W Oslin; Kyle M Kampman; Charles A Dackis Journal: J Clin Psychopharmacol Date: 2006-12 Impact factor: 3.153
Authors: Dilip V Jeste; Barton W Palmer; Paul S Appelbaum; Shahrokh Golshan; Danielle Glorioso; Laura B Dunn; Kathleen Kim; Thomas Meeks; Helena C Kraemer Journal: Arch Gen Psychiatry Date: 2007-08
Authors: Raymond F Anton; Stephanie S O'Malley; Domenic A Ciraulo; Ron A Cisler; David Couper; Dennis M Donovan; David R Gastfriend; James D Hosking; Bankole A Johnson; Joseph S LoCastro; Richard Longabaugh; Barbara J Mason; Margaret E Mattson; William R Miller; Helen M Pettinati; Carrie L Randall; Robert Swift; Roger D Weiss; Lauren D Williams; Allen Zweben Journal: JAMA Date: 2006-05-03 Impact factor: 56.272
Authors: Susan E Collins; Seema L Clifasefi; Lonnie A Nelson; Joey Stanton; Silvi C Goldstein; Emily M Taylor; Gail Hoffmann; Victor L King; Alyssa S Hatsukami; Zohar Lev Cunningham; Ellie Taylor; Nigel Mayberry; Daniel K Malone; T Ron Jackson Journal: Int J Drug Policy Date: 2019-03-06
Authors: Susan E Collins; Silvi C Goldstein; Victorio L King; Victoria E Orfaly; Jingyan Gu; Alex Clark; Alexander Vess; Gary Lee; Emily M Taylor; Taurmini Fentress; Ashley K Braid; Seema L Clifasefi Journal: J Community Psychol Date: 2020-12-10