Clinical trial NCT01932801: Harm Reduction With Pharmacotherapy (HaRP)
Official title: Harm Reduction With Pharmacotherapy for Homeless Adults With Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Use Disorder
Keywords: harm reduction, naltrexone, alcohol use disorder, homelessness
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Alkermes, Inc.
First posted: 2013-08-30
Enrollment: 308
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to test the efficacy of extended-release naltrexone and harm reduction counseling in reducing alcohol-related harm among homeless people with alcohol dependence.

Detailed description: Homelessness and alcohol dependence are commonly co-occurring and serious public health issues. Unfortunately, abstinence-based alcohol treatment approaches are minimally effective in engaging and successfully treating homeless individuals with alcohol dependence. There have therefore been calls for more flexible and client-centered approaches tailored to this population's needs. Innovative, low-barrier approaches (e.g., Housing First and alcohol management programs) have been applied with this population and are efficacious in reducing alcohol use and related problems as well as utilization of publicly funded services and associated costs. Such approaches have been referred to as harm-reduction interventions because they focus on reducing alcohol-related harm for affected individuals and their communities without requiring a commitment to abstinence-based goals. Although psychosocial, harm-reduction approaches are beginning to proliferate for this population, there are few pharmacological counterparts to support and enhance these efforts. One medication that could address this treatment gap is extended-release naltrexone (XR-NTX; marketed as Vivitrol®). XR-NTX is a 30-day, extended release formulation of the opioid receptor antagonist, naltrexone, and is administered monthly via gluteal intramuscular injection. The proposed Phase II study features a four-arm RCT (N=300) designed to test the efficacy of XR-NTX as a pharmacological adjunct to existing psychosocial harm-reduction services provided by community agencies to homeless people with alcohol dependence. The proposed study will include a 24-week follow-up and will test the relative efficacy of 3 active treatment combinations-1) XR-NTX+harm reduction counseling, 2) placebo+harm reduction counseling and 3) harm reduction counseling only (HRC)-compared to the services as usual (TAU) that all participants receive from community agencies. This proposed design will allow us to dismantle active treatment components and thereby detect potential "placebo effects" of both the administration of an injection and attention from a medical professional. In this study, there are three primary specific aims. First, we will test the relative efficacy of XR-NTX, placebo and HRC compared to TAU in decreasing alcohol quantity, frequency and alcohol-related problems. Second, we will test hypothesized mediators of the intervention effects. Specifically, we hypothesize that the active treatments will precipitate increases in motivation to change and decreases in craving, which, in turn, will mediate the active treatment effects on alcohol outcomes. Finally, we will test treatment effects on publicly funded service costs (i.e., emergency medical services, ER visits, hospital admissions, and county jail). It is hypothesized that XR-NTX, placebo and HRC groups will show greater decreases in publicly funded service costs than the TAU group.

Eligibility criteria: Inclusion Criteria:

* being a registered client at one of the named partnering sites
* being at least 21 years of age (for legal reasons)
* agreeing to use an adequate form of birth control (if female and in childbearing years) fulfilling criteria for current alcohol dependence according to DSM-IV-TR criteria as determined by the SCID-I/P

Exclusion Criteria:

* refusal or inability to consent to participation in research
* constituting a risk to safety and security of other clients or staff
* known sensitivity or allergy to naltrexone/XR-NTX
* current treatment with naltrexone/XR-NTX
* being pregnant or nursing
* suicide attempts within the past year
* renal insufficiency/serum creatinine level \> 1.5
* current opioid dependence according to the DSM-IV-TR criteria
* liver transaminases (AST, ALT) \> 5 times the upper limit of normal (ULN)
* clinical diagnosis of decompensated liver disease

Primary outcomes:
measure: Alcohol Quantity
timeFrame: Baseline, week 4, week 8, week 12, week 24, week 36
measure: Alcohol-related Harm
timeFrame: Baseline, week 4, week 8, week 12, week 24, week 36
measure: Alcohol Frequency
timeFrame: baseline, week 0, week 4, week 8, week 12, week 24, week 36
Secondary outcomes:
measure: Motivation to Change Ruler
timeFrame: baseline, week 4, week 8, week 12, week 24, week 36
measure: Alcohol Craving
timeFrame: baseline, week 4, week 8, week 12, week 24, week 36
measure: Publicly Funded Service Utilization Costs
timeFrame: 2yr pretest, 12-week treatment period, 24-week follow-up period
Other outcomes:
measure: Adverse Events Due to the Study Medication
timeFrame: baseline, week 4, week 8, week 12, week 24, week 36
Locations:
city: Seattle
country: United States
facility: University of Washington - Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Susan E Collins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Collins SE, Saxon AJ, Duncan MH, Smart BF, Merrill JO, Malone DK, Jackson TR, Clifasefi SL, Joesch J, Ries RK. Harm reduction with pharmacotherapy for homeless people with alcohol dependence: protocol for a randomized controlled trial. Contemp Clin Trials. 2014 Jul;38(2):221-34. doi: 10.1016/j.cct.2014.05.008. Epub 2014 May 17.
citation: Collins SE, Duncan MH, Saxon AJ, Taylor EM, Mayberry N, Merrill JO, Hoffmann GE, Clifasefi SL, Ries RK. Combining behavioral harm-reduction treatment and extended-release naltrexone for people experiencing homelessness and alcohol use disorder in the USA: a randomised clinical trial. Lancet Psychiatry. 2021 Apr;8(4):287-300. doi: 10.1016/S2215-0366(20)30489-2. Epub 2021 Mar 10.
citation: Fentress TSP, Wald S, Brah A, Leemon G, Reyes R, Alkhamees F, Kramer M, Taylor EM, Wildhood M, Frohe T, Duncan MH, Clifasefi SL, Collins SE. Dual study describing patient-driven harm reduction goal-setting among people experiencing homelessness and alcohol use disorder. Exp Clin Psychopharmacol. 2021 Jun;29(3):261-271. doi: 10.1037/pha0000470.
citation: Goldstein SC, Spillane NS, Tate MC, Nelson LA, Collins SE. Measurement invariance and other psychometric properties of the Short Inventory of Problems (SIP-2R) across racial groups in adults experiencing homelessness and alcohol use disorder. Psychol Addict Behav. 2023 Mar;37(2):199-208. doi: 10.1037/adb0000833. Epub 2022 May 5.