Randomized controlled trial of harm reduction treatment for alcohol (HaRT-A) for people experiencing homelessness and alcohol use disorder.

BACKGROUND: People experiencing homelessness are disproportionately affected by alcohol use disorder (AUD). Abstinence-based treatment, however, does not optimally engage or treat this population. Thus, harm reduction treatment for alcohol (HaRT-A) was developed together with people with lived experience of homelessness and AUD and community-based agencies that serve them. HaRT-A is a compassionate and pragmatic approach that aims to help people reduce alcohol-related harm and improve quality of life (QoL) without requiring abstinence or use reduction. A three-month, two-arm randomized controlled trial was conducted to test the initial efficacy of HaRT-A compared to a services-as-usual control condition. METHODS: People experiencing homelessness and AUD (N = 168; 24% women) were recruited in community-based clinical and social services settings. Self-reported alcohol use, alcohol-related harm, motivation, and QoL as well as urinary ethyl glucuronide were assessed over a 3-month follow-up. Participants were randomized to receive HaRT-A or services as usual. Over four sessions, HaRT-A interventionists delivered three components: a) collaborative tracking of participant-preferred alcohol metrics, b) elicitation of harm-reduction and QoL goals, and c) discussion of safer-drinking strategies. RESULTS: Compared to control participants, HaRT-A participants reported significantly greater increases in confidence to engage in harm reduction and decreases in peak alcohol use, alcohol-related harm, AUD symptoms, and positive urinary ethyl glucuronide tests (ps < .05). Findings were inconclusive regarding group differences on QoL (ps > .12). CONCLUSION: A low-barrier, low-intensity, patient-driven, harm-reduction approach has at least short-term efficacy in improving AUD outcomes in this population. Future studies are needed to establish its longer-term efficacy.

Finding harmony so the music plays on: pragmatic trial design considerations to promote organizational sustainment of an empirically-supported behavior therapy.

BACKGROUND: Pragmatic trials of empirically-supported behavior therapies may inform clinical and policy decisions concerning therapy sustainment. This retrospective trial design paper describes and discusses pragmatic features of a hybrid type III implementation/effectiveness trial of a contingency management (CM) intervention at an opioid treatment program. Prior reporting (Hartzler et al., J Subst Abuse Treat 46:429-438, 2014; Hartzler, Subst Abuse Treat Prev Policy 10:30, 2015) notes success in recruiting program staff for voluntary participation, durable impacts of CM training on staff-level outcomes, provisional setting implementation of the intervention, documentation of clinical effectiveness, and post-trial sustainment of CM. METHODS/DESIGN: Six pragmatic design features, and both scientific and practical bases for their inclusion in the trial, are presented: (1) a collaborative intervention design process, (2) voluntary recruitment of program staff for therapy training and implementation, (3) serial training outcome assessments, with quasi-experimental staff randomization to either single or multiple baseline assessment conditions, (4) designation of a 90-day period immediately after training in which the setting implemented the intervention on a provisional basis, (5) inclusive patient eligibility for receipt of the CM intervention, and (6) designation of two staff as local implementation leaders to oversee clinical/administrative issues in provisional implementation. DISCUSSION: Each pragmatic trial design feature is argued to have contributed to sustainment of CM. Contributions implicate the building of setting proprietorship for the CM intervention, culling of internal staff expertise in its delivery, iterative use of assessment methods that limited setting burden, documentation of setting-specific clinical effectiveness, expanded penetration of CM among staff during provisional implementation, and promotion of setting self-reliance in the oversight of sustainable implementation procedures. It is hoped this discussion offers ideas for how to impact local clinical and policy decisions via effective behavior therapy dissemination.

Extended-release naltrexone and harm reduction counseling for chronically homeless people with alcohol dependence.

BACKGROUND: Abstinence-based alcohol interventions are minimally desirable to and effective for chronically homeless individuals with alcohol dependence who have multimorbidity and high publicly funded service utilization and associated costs. Lower-barrier, patient-centered combined pharmacobehavioral interventions may more effectively treat this population. Harm reduction counseling involves a nonjudgmental, empathic style and patient-driven goal setting that requires neither abstinence nor use reduction. Extended-release naltrexone (XR-NTX), a monthly injectable formulation of an opioid receptor antagonist, reduces craving, is safe and effective for active drinkers, and may thereby support harm reduction goal setting. The aims of this 12-week, single-arm pilot were to initially document some aspects of feasibility, acceptability, and alcohol outcomes following XR-NTX administration and harm reduction counseling for chronically homeless individuals with alcohol dependence. METHODS: Participants were currently/formerly chronically homeless, alcohol-dependent individuals (N = 31) from 2 community-based agencies in the US Pacific Northwest. Measures included self-reported alcohol craving, quantity/frequency, problems, and biomarkers (ethyl glucuronide [EtG], liver transaminases). XR-NTX and harm reduction counseling were administered monthly over the 3-month treatment course. RESULTS: Of the 45 individuals approached, 43 were interested in participation. The first injection was received by 31 participants, and 24 complied with all study procedures. Participants reported the treatment was acceptable. Participants evinced decreases in alcohol craving (33%), typical (25%) and peak (34%) use, frequency (17%), problems (60%), and EtG from the baseline to the 12-week follow-up (Ps < .05). CONCLUSIONS: XR-NTX and harm reduction counseling are promising means of supporting reductions in alcohol use and alcohol-related harm among chronically homeless, alcohol-dependent individuals.

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. 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.

Disseminating contingency management: impacts of staff training and implementation at an opiate treatment program.

Guided by a comprehensive implementation model, this study examined training/implementation processes for a tailored contingency management (CM) intervention instituted at a Clinical Trials Network-affiliate opioid treatment program (OTP). Staff-level training outcomes (intervention delivery skill, knowledge, and adoption readiness) were assessed before and after a 16-hour training, and again following a 90-day trial implementation period. Management-level implementation outcomes (intervention cost, feasibility, and sustainability) were assessed at study conclusion in a qualitative interview with OTP management. Intervention effectiveness was also assessed via independent chart review of trial CM implementation vs. a historical control period. Results included: 1) robust, durable increases in delivery skill, knowledge, and adoption readiness among trained staff; 2) positive managerial perspectives of intervention cost, feasibility, and sustainability; and 3) significant clinical impacts on targeted patient indices. Collective results offer support for the study's collaborative intervention design and the applied, skills-based focus of staff training processes. Implications for CM dissemination are discussed.

Social workers and delivery of evidence-based psychosocial treatments for substance use disorders.

Social workers encounter individuals with substance use disorders (SUDs) in a variety of settings. With changes in health care policy and a movement toward integration of health and behavioral health services, social workers will play an increased role vis-á-vis SUD. As direct service providers, administrators, care managers, and policy makers, they will select, deliver, or advocate for delivery of evidence-based SUD treatment practices. This article provides an overview of effective psychosocial SUD treatment approaches. In addition to describing the treatments, the article discusses empirical support, populations for whom the treatments are known to be efficacious, and implementation issues.

Methadone medical maintenance in primary care. An implementation evaluation.

BACKGROUND: Methadone is effective treatment for opioid addiction, but regulations restrict its use. Methadone medical maintenance treats stabilized methadone patients in a medical setting, but only experimental programs have been studied. OBJECTIVE: To evaluate the implementation of the first methadone medical maintenance program established outside a research setting. DESIGN: One-year program evaluation. SETTING: A public hospital and a community opioid treatment program. PARTICIPANTS: Methadone patients with >1 year of clinical stability. Eleven generalist physicians and 4 hospital pharmacists. INTERVENTIONS: Regulatory exemptions were requested. Physicians and pharmacists were trained. Patients were transferred to the medical setting and permitted 1-month supplies of methadone. MEASUREMENTS: Patient eligibility and willingness to enroll, treatment retention, urine toxicology results, change in addiction severity and functional status, medical services provided, patient and physician satisfaction, and physician attitudes toward methadone maintenance. RESULTS: Regulatory exemptions were obtained after a 14-month process, and the program was cited in federal policy as acceptable for widespread implementation. Forty-nine of 684 patients (7.2%) met stability criteria, and 30 enrolled. Twenty-eight were retained for 1 year, and 2 transferred to other programs. Two patients had opioid-positive urine tests and were managed in the medical setting. Previously unmet medical needs were addressed, and the Addiction Severity Index (ASI) medical composite score improved over time (P=.02). Patient and physician satisfaction were high, and physician attitudes toward methadone maintenance treatment became more positive (P=.007). CONCLUSIONS: Methadone medical maintenance is complex to arrange but feasible outside a research setting, and can result in good clinical outcomes.

Primary heroin users + drug-free treatment: an equation for success?

This study of persons referred to publicly funded drug-free substance abuse treatment in Washington State compares 122 primary heroin users (those specifying heroin as a drug of choice) with 532 persons who preferred other substances. Information on treatment entry and completion was obtained through review of client charts at the referral agency. Follow-up interviews with 587 participants provided self-reports of substance use during a 90-day period 3-6 months following removal from the treatment waitlist. Primary heroin users were significantly less likely than others to enter the treatment programs to which they were referred. Among treatment entrants, primary heroin users were somewhat less likely than other users to complete inpatient programs but no less likely to complete outpatient programs. The heroin preference group reported less abstinence and greater frequency of use during the follow-up period than did other users, patterns that almost entirely coincided with the lower treatment compliance in the heroin group. The authors note the importance of investigating methods for increasing treatment entry rates for opiate users who desire drug-free treatment.

Acupuncture for the treatment of cocaine addiction: a randomized controlled trial.

CONTEXT: Auricular acupuncture is widely used to treat cocaine addiction in the United States and Europe. However, evidence from controlled studies regarding this treatment's effectiveness has been inconsistent. OBJECTIVE: To investigate the effectiveness of auricular acupuncture as a treatment for cocaine addiction. DESIGN: Randomized, controlled, single-blind clinical trial conducted from November 1996 to April 1999. SETTING: Six community-based clinics in the United States: 3 hospital-affiliated clinics and 3 methadone maintenance programs. PATIENTS: Six hundred twenty cocaine-dependent adult patients (mean age, 38.8 years; 69.2% men); 412 used cocaine only and 208 used both opiates and cocaine and were receiving methadone maintenance. INTERVENTION: Patients were randomly assigned to receive auricular acupuncture (n = 222), a needle-insertion control condition (n = 203), or a relaxation control condition (n = 195). Treatments were offered 5 times weekly for 8 weeks. Concurrent drug counseling was also offered to patients in all conditions. MAIN OUTCOME MEASURES: Cocaine use during treatment and at the 3- and 6-month postrandomization follow-up based on urine toxicology screens; retention in treatment. RESULTS: Intent-to-treat analysis of urine samples showed a significant overall reduction in cocaine use (odds ratio, 1.40; 95% confidence interval, 1.11-1.74; P =.002) but no differences by treatment condition (P =.90 for acupuncture vs both control conditions). There were also no differences between the conditions in treatment retention (44%-46% for the full 8 weeks). Counseling sessions in all 3 conditions were poorly attended. CONCLUSIONS: Within the clinical context of this study, acupuncture was not more effective than a needle insertion or relaxation control in reducing cocaine use. Our study does not support the use of acupuncture as a stand-alone treatment for cocaine addiction or in contexts in which patients receive only minimal concurrent psychosocial treatment. Research will be needed to examine acupuncture's contribution to addiction treatment when provided in an ancillary role.

Treatment practice and research issues in improving opioid treatment outcomes.

Providers of treatment for opioid addiction have entered a new era of accountability, as Federal and State regulators increasingly demand objective evidence of treatment effectiveness. Since the length of treatment is associated with success of treatment, opioid treatment programs that demonstrate an ability to retain patients can make a strong case that they are effective. The challenge to opioid treatment providers is to examine their practices and begin organizational change to incorporate scientifically proven practices to improve patient retention. The challenge to the research community is to partner more effectively with community-based providers to help them through the transition.