Can abuse deterrent formulations make a difference? Expectation and speculation

It is critical that issues surrounding the abuse and misuse of prescription opioids be balanced with the need for these medications for the treatment of pain. One way to decrease the abuse of prescription opioid medications is to develop abuse deterrent formulations (or ADFs) that in some way prevent drug abusers from extracting out the active ingredient in order to employ alternate routes of administration, such as injection, snorting, and smoking. Several factors including the pharmacokinetic profile of the drug, the features of the drug formulation that make it attractive or unattractive for abuse, the type of drug abuser, the progression of one's addiction pathway, and one's social environment may all play a role in the abuse of prescription opioids and what methods are used to abuse these drugs. This paper will examine these factors in order to understand how they affect the abuse of prescription opioids and routes of administration, and how the development of ADFs may alter these patterns

Current progress of DNA vaccine studies in humans

Despite remarkable progress in the field of DNA vaccine research since its discovery in the early 1990 s, the formal acceptance of this novel technology as a new modality of human vaccines depends on the successful demonstration of its safety and efficacy in advanced clinical trials. Although clinical trials conducted so far have provided overwhelming evidence that DNA vaccines are well tolerated and have an excellent safety profile, the early designs of DNA vaccines failed to demonstrate sufficient immunogenicity in humans. However, studies conducted over the last few years have led to promising results, particularly when DNA vaccines were used in combination with other forms of vaccines. Here, we provide a review of the data from reported DNA vaccine clinical studies with an emphasis on the ability of DNA vaccines to elicit antigen-specific, cell-mediated and antibody responses in humans. The majority of these trials are designed to test candidate vaccines against several major human pathogens and the remaining studies tested the immunogenicity of therapeutic vaccines against cancer

Typologies of Prescription Opioid Use in a Large Sample of Adults Assessed for Substance Abuse Treatment

Background: As a population, non-medical prescription opioid users are not well-defined. We aimed to derive and describe typologies of prescription opioid use and nonmedical use using latent class analysis in an adult population being assessed for substance abuse treatment. Methods: Latent class analysis was applied to data from 26,314 unique respondents, aged 18-70, self-reporting past month use of a prescription opioid out of a total of 138,928 cases (18.9%) collected by the Addiction Severity Index-Multimedia Version (ASI-MVH), a national database for near real-time prescription opioid abuse surveillance. Data were obtained from November 2005 through December 2009. Substance abuse treatment, criminal justice, and public assistance programs in the United States submitted data to the ASI-MV database (n = 538). Six indicators of the latent classes derived from responses to the ASI-MV, a version of the ASI modified to collect prescription opioid abuse and chronic pain experience. The latent class analysis included respondent home ZIP code random effects to account for nesting of respondents within ZIP code. Results: A four-class adjusted latent class model fit best and defined clinically interpretable and relevant subgroups: Use as prescribed, Prescribed misusers, Medically healthy abusers, and Illicit users. Classes varied on key variables, including race/ethnicity, gender, concurrent substance abuse, duration of prescription opioid abuse, mental health problems, and ASI composite scores. Three of the four classes (81% of respondents) exhibited high potential risk for fatal opioid overdose; 18.4% exhibited risk factors for blood-borne infections. Conclusions: Multiple and distinct profiles of prescription opioid use were detected, suggesting a range of use typologies at differing risk for adverse events. Results may help clinicians and policy makers better focus overdose and blood-borne infection prevention efforts and intervention strategies for prescription opioid abuse reduction

Estimating Attractiveness for Abuse of A Not-Yet-Marketed “Abuse Deterrent” Prescription Opioid Formulation

Objective: The present study builds on research to model abusers\u27 perceptions of particular analgesics\u27 attractiveness for abuse and extends these methods to derive an estimate of attractiveness for abuse of a not-yet-marketed abuse-deterrent formulation (ADF) of a prescription opioid (Remoxy), Pain Therapeutics, Inc., San Mateo, CA, and King Pharmaceuticals, Inc., Bristol, TN). In a previous study, the Opioid Attractiveness Technology Scaling (OATS) method identified, from a drug abuser\u27s point of view, the particular features of a prescription opioid relevant to its attractiveness for recreational use. A second online sample rated the extent to which these features applied to particular products they had actually used/abused. These data were used to model the abusers\u27 overall preference for prescription opioids they had used/abused. Design: In the present study, this method was applied to a not-yet-marketed ADF using substance abuse counselors as proxies for prescription opioid abusers. Thirty-eight counselors were given materials describing the new ADF along with four known products. Results: Thirty-two counselors demonstrated sufficient agreement with abusers\u27 ratings of the overall attractiveness of these drugs. The overall model yielded a significant pseudo R(2) of 0.15 (P \u3c 0.001), with increasing model fit based on preferred route of administration, from swallowing whole (pseudo R(2) = 0.06; P \u3c 0.001) and best for those who preferred to inject (pseudo R(2) = 0.40; P \u3c 0.001). Data from a cross-validation group of 16 counselors/proxies were used to calculate the OATS scores for the five rated drugs and revealed significant differences between the ADF and OxyContin (Purdue Pharma LP, Stamford, CT), Percocet (Endo Pharmaceuticals, Chadds Ford, PA), and Vicodin (Abbott Laboratories, Abbott Park, IL), but not Talwin NX (Sanofi-aventis, Bridgewater, NJ), which was identified in the prior study as a highly unattractive drug for recreational purposes. Conclusions: The OATS method shows promise for providing pre-marketing estimates of attractiveness for abuse of not-yet-marketed ADF

Characteristics of Prescription Opioid Abusers in Treatment: Opioid Use History, Age, Use Patterns, and Functional Severity

Research has raised the possibility that the length of time one engages in nonmedical use of prescription opioids may be associated with abuse of other drugs, more risky drug-related behavior, and more severe functional problems. This study drew on data from the Addiction Severity Index-Multimedia Version Connect system. A total of 55,341 client assessments at substance abuse treatment centers were analyzed to help understand the impact of length of time one has abused opioids on the patterns of abuse and functional problems. From this larger sample, 5686 individuals who had abused a prescription opioid within the past 30 days were studied. Multiple logistic regression analyses were run to examine the impact of length of time abusing any opioid, after adjusting for several demographic variables, on route of administration (injection or injection/snorting), other drugs abused, and functioning in the areas of medical status, employment, drug and alcohol use, legal status, family and social problems, and psychiatric status. Overall findings supported the hypothesis that length of opioid abuse is associated with higher risk of drug use patterns as well as functional problems

Health Care Provider Perceptions of Pain Treatment in Hispanic Patients

Despite increasing numbers of Hispanic patients in the United States, this group continues to face disparities in access and quality of pain treatment. Although previous surveys have examined treatment disparities experienced by minority patients, none have provided a provider-centric perspective on issues and concerns surrounding pain relief among pain patients of Hispanic/Latino origin. The goal of this study was to assess the relationship between provider characteristics (ie, Spanish fluency, Hispanic caseload size, and experience with Hispanic pain patients) and their perceptions of pain treatment in these patients. One hundred eighty-seven health professionals completed an online survey. The major findings indicated that: (1) less than 20% of health professionals treating Hispanic pain patients reported Spanish proficiency at an advanced level; (2) surveyed health professionals were involved treating a significant proportion of Hispanic patients in their caseloads, but reported a lack of cultural competence training; (3) Spanish fluency and experience with Hispanic pain patients exerts a strong effect on the use of established pain treatment practices; (4) providers with greater Spanish fluency report a significantly greater effect of patients\u27 cultural beliefs and attitudes on treatment; and (5) providers did not regard cultural or language barriers as significantly impacting opioid prescribing or patient compliance

Addiction Severity Index composite scores by latent prescription opioid use class.

<p>All one-way ANOVAs were statistically significant (p<0.05 or less) from one another, conducted with F (3, 26,311). The one-way ANOVAs returned results larger than the critical value of 2.70 (p = 0.05) or 3.98 (p = 0.01). In post-hoc comparisons of the ASI composites across classes, same letter superscripts denote statistically similar values, where p≥.05 in Tukey-Kramer post-hoc ANOVA tests. All other post-hoc comparisons were statistically different from one another. For instance, for ASI Employment, classes 1 and 2 have similar values (p>0.05) which are statistically different from classes 3 and 4 (p<0.05).</p><p>SD = standard deviation.</p

Class prevalence among the study sample and adjusted probabilities of responding to each indicator conditional upon membership in the latent class.

<p>*To understand this table’s content, take for instance class 1, which had a prevalence of 18.9%. Conditional upon membership in this class, class 1 respondents had very low adjusted probabilities (close to 0) of responding ‘Yes’ to the first 4 indicators listed and very high adjusted probabilities (close to 1.0) of responding ‘Yes’ to the last two indicators: ‘Has a current chronic medical health problem/pain problem’ and ‘Takes prescribed medication for a medical problem/Receives help for a medical problem, past 30 days’. Based on this pattern of response, class 1 was labeled, for ease of discussion, as ‘use as prescribed’.</p