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

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.

Trial registration: ClinicalTrials.gov NCT01932801.

Keywords: Alcohol dependence; Alcohol treatment; Extended-release naltrexone; Harm reduction; Homelessness.

Figure 1

Intervention delivery and assessment timeline.

Figure 2

Harm-reduction goal elicitation protocol and forms.

Figure 3

Safer drinking tips are introduced by study interventionists with the following prompts: 1) If they have already mentioned wanting to reduce their drinking, this can be pointed out on the list, and this goal can be reinforced as a step towards safer drinking. 2) Inquire if they have ever done any of the things on the list to reduce the harm they experience while drinking. For example,“This is a list of things that you can do to drink more safely. Have you ever tried doing anything on this list before?” If so, ask participants: “How did that go?” or “What was that like for you?” Support participants’ self-efficacy by reinforcing these efforts. For example, “It's great that you have been able to keep from drinking while you sell your Real Change papers. What made you decide to do that? How were you able to do that?” 3) Ask if they would be willing to choose a couple of safer drinking tips over the next month (or until the next appointment)—circle these for participants and note these on the CRF under “Participant's Safer Drinking Plan.” 4) Inform participants you will check in with them during the next meeting about their safer drinking plan to see how it worked out for them. 5) Participants should receive the safer drinking tips handout (with their harm reduction goals on the back) to take with them.

Figure 4

Hypothesized primary intervention model. “Intercept” is the baseline measurement of the outcome variable (DV). HRC = harm reduction counseling only. “Slope” represents change in the DV over time. DV= outcome or dependent variable. D=latent variable disturbance (error). E=measured variable error.