Context Sustained-release naltrexone implants may improve outcomes of nonagonist treatment of opioid addiction. Objective To compare outcomes of naltrexone implants, oral naltrexone hydrochloride, and nonmedication treatment. Design Six-month double-blind, double-dummy, randomized trial. Setting Addiction treatment programs in St Petersburg, Russia. Participants Three hundred six opioid-addicted patients recently undergoing detoxification. Interventions Biweekly counseling and 1 of the following 3 treatments for 24 weeks: (1) 1000-mg naltrexone implant and oral placebo (NI+OP group; 102 patients); (2) placebo implant and 50-mg oral naltrexone hydrochloride (PI+ON group; 102 patients); or (3) placebo implant and oral placebo (PI+OP group; 102 patients). Main Outcome Measure Percentage of patients retained in treatment without relapse. Results By month 6, 54 of 102 patients in the NI+OP group (52.9%) remained in treatment without relapse compared with 16 of 102 patients in the PI+ON group (15.7%) (survival analysis, log-rank test, P<.001) and 11 of 102 patients in the PI+OP group (10.8%) (P<.001). The PI+ON vs PI+OP comparison showed a nonsignificant trend favoring the PI+ON group (P=.07). Counting missing test results as positive, the proportion of urine screening tests yielding negative results for opiates was 63.6% (95% CI, 60%-66%) for the NI+OP group; 42.7% (40%-45%) for the PI+ON group; and 34.1% (32%-37%) for the PI+OP group (P<.001, Fisher exact test, compared with the NI+OP group). Twelve wound infections occurred among 244 implantations (4.9%) in the NI+OP group, 2 among 181 (1.1%) in the PI+ON group, and 1 among 148 (0.7%) in the PI+OP group (P=.02). All events were in the first 2 weeks after implantation and resolved with antibiotic therapy. Four local-site reactions (redness and swelling) occurred in the second month after implantation in the NI+OP group (P=.12), and all resolved with antiallergy medication treatment. Other nonlocal-site adverse effects were reported in 8 of 886 visits (0.9%) in the NI+OP group, 4 of 522 visits (0.8%) in the PI+ON group, and 3 of 394 visits (0.8%) in the PI+ON group; all resolved and none were serious. No evidence of increased deaths from overdose after naltrexone treatment ended was found. Conclusions The implant is more effective than oral naltrexone or placebo. More patients in the NI+OP than in the other groups develop wound infections or local irritation, but none are serious and all resolve with treatment.
Although advances in pharmacotherapy have enabled people living with HIV/AIDS to live longer, fuller lives, some leave medical care, resulting in sub-optimal treatment and increased health risk to themselves and others. Forty-one patients who dropped out of an urban, publically funded primary care HIV clinic were contacted and encouraged by outreach staff to return. Participants were interviewed within two weeks of returning, and themes associated with dropping out and returning were elicited and content analyzed. Dropping out was associated with drug/alcohol use, unstable housing/homelessness, psychiatric disorders, incarceration, problems with HIV medications, inability to accept the diagnosis, relocation, stigma, problems with the clinic, and forgetfulness. Returning was associated with health concerns, substance abuse treatment/recovery, stable housing, incarceration/release, positive feelings about the clinic, spirituality, and assistance from family/relocation. Because a large number of patients reported substance abuse, depression, and past suicide attempts. Clinic staff should assess substance use, depression, and suicidal ideation at each primary care visit and encourage patients to obtain substance abuse treatment and mental health care. Future interventions could include providing SBIRT and/or onsite mental health and substance abuse treatment, all of which may boost retention.
BackgroundPatients with untreated substance use disorders (SUDs) are at risk for frequent emergency department visits and repeated hospitalizations. Project Engage, a US pilot program at Wilmington Hospital in Delaware, was conducted to facilitate entry of these patients to SUD treatment after discharge. Patients identified as having hazardous or harmful alcohol consumption based on results of the Alcohol Use Disorders Identification Test-Primary Care (AUDIT-PC), administered to all patients at admission, received bedside assessment with motivational interviewing and facilitated referral to treatment by a patient engagement specialist (PES). This program evaluation provides descriptive information on self-reported rates of SUD treatment initiation of all patients and health-care utilization and costs for a subset of patients.MethodsProgram-level data on treatment entry after discharge were examined retrospectively. Insurance claims data for two small cohorts who entered treatment after discharge (2009, n = 18, and 2010, n = 25) were reviewed over a six-month period in 2009 (three months pre- and post-Project Engage), or over a 12-month period in 2010 (six months pre- and post-Project Engage). These data provided descriptive information on health-care utilization and costs. (Data on those who participated in Project Engage but did not enter treatment were unavailable).ResultsBetween September 1, 2008, and December 30, 2010, 415 patients participated in Project Engage, and 180 (43%) were admitted for SUD treatment. For a small cohort who participated between June 1, 2009, and November 30, 2009 (n = 18), insurance claims demonstrated a 33% ($35,938) decrease in inpatient medical admissions, a 38% ($4,248) decrease in emergency department visits, a 42% ($1,579) increase in behavioral health/substance abuse (BH/SA) inpatient admissions, and a 33% ($847) increase in outpatient BH/SA admissions, for an overall decrease of $37,760. For a small cohort who participated between June 1, 2010, and November 30, 2010 (n = 25), claims demonstrated a 58% ($68,422) decrease in inpatient medical admissions; a 13% ($3,308) decrease in emergency department visits; a 32% ($18,119) decrease in BH/SA inpatient admissions, and a 32% ($963) increase in outpatient BH/SA admissions, for an overall decrease of $88,886.ConclusionsThese findings demonstrate that a large percentage of patients entered SUD treatment after participating in Project Engage, a novel intervention with facilitated referral to treatment. Although the findings are limited by the retrospective nature of the data and the small sample sizes, they do suggest a potentially cost-effective addition to existing hospital services if replicated in prospective studies with larger samples and controls.
Background Naltrexone is a μ-opioid receptor antagonist that blocks opioid effects. Craving, depression, anxiety, and anhedonia are common among opioid dependent individuals and concerns have been raised that naltrexone increases them due to blocking endogenous opioids. Here we present data that addresses these concerns. Objective Assess the relationship between affective responses and naltrexone treatment. Methods Opioid dependent patients (N=306) were enrolled in a three cell (102ss/cell) randomized, double blind, double dummy, placebo-controlled 6-month trial comparing extended release implantable naltrexone with oral naltrexone and placebo (oral and implant). Monthly assessments of affective responses used a Visual Analog Scale for opioid craving, the Beck Depression Inventory, Spielberger Anxiety Test, and the Ferguson and Chapman Anhedonia Scales. Between group outcomes were analyzed using mixed model analysis of variance (Mixed ANOVA) and repeated measures and the Tukey test for those who remained and treatment and did not relapse, and between the last measure before dropout with the same measure for those remaining in treatment. Results Depression, anxiety, and anhedonia were elevated at baseline but reduced to normal within the first 1-2 months for patients who remained in treatment and did not relapse. Other than a slight increase in two anxiety measures at week two, there were no significant between group differences prior to treatment dropout. Conclusion These data do not support concerns that naltrexone treatment of opioid dependence increases craving, depression, anxiety or anhedonia.
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