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


OBJECTIVE
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.


CONCLUSIONS
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.
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.
Susan E
SE
Collins
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.
Andrew J
AJ
Saxon
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.
Mark H
MH
Duncan
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.
Brian F
BF
Smart
Department of Medicine, University of Washington - Harborview Medical Center, 325 Ninth Ave, Box 359780, Seattle, WA 98195, USA. Electronic address: joem@uw.edu.
Joseph O
JO
Merrill
Downtown Emergency Service Center (DESC), 515 Third Ave, Seattle, WA 98104, USA. Electronic address: dmalone@desc.org.
Daniel K
DK
Malone
Evergreen Treatment Services - REACH, 1700 Airport Way S, Seattle, WA 98134, USA. Electronic address: ronjack@uw.edu.
T Ron
TR
Jackson
Department of Psychiatry and Behavioral Sciences, University of Washington, 1100 45th St. Box 354944, Seattle, WA 98195, USA. Electronic address: seemac@uw.edu.
Seema L
SL
Clifasefi
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.
Jutta
J
Joesch
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.
Richard K
RK
Ries
D000328:Adult; D000368:Aged; D000428:Alcohol Drinking / Q000188:drug therapy; D000437:Alcoholism / Q000188:drug therapy / Q000628:therapy*; D015415:Biomarkers; D003376:Counseling / Q000379:methods*; D066249:Craving / Q000187:drug effects; D003692:Delayed-Action Preparations; D005260:Female; D040261:Harm Reduction; D006296:Health Services / Q000191:economics / Q000706:statistics & numerical data; D006703:Ill-Housed Persons; D006801:Humans; D008297:Male; D008875:Middle Aged; D009042:Motivation; D009271:Naltrexone / Q000008:administration & dosage / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D011632:Public Assistance; D011788:Quality of Life; D012107:Research Design
D015415:Biomarkers; D003692:Delayed-Action Preparations; D009292:Narcotic Antagonists; D009271:Naltrexone
Alcohol dependence; Alcohol treatment; Extended-release naltrexone; Harm reduction; Homelessness