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Opioid Abuse [keywords]
- Painful decision-making at FDA. [JOURNAL ARTICLE]
- Expert Opin Drug Saf 2014 Mar 6.
The FDA is critical in ensuring that medications are safe and effective. However, the FDA's decision-making process for opioid analgesics is complicated by the need to address patients with complex clinical pain syndromes while balancing public safety concerns involving opioid misuse and abuse. Several recent regulatory decisions by FDA have exposed the complexity of this regulatory tug of war. For example, the FDA's decision to include a requirement for tamper resistance for extended-release oxycodone products but not for extended-release oxymorphone or hydrocodone preparations is concerning. Although tamper resistance is an imperfect solution, it provides a modicum of abuse prevention. Additionally, the rewording of the labeled indication (from 'moderate to severe pain' to 'severe enough pain') for extended-release opioid analgesics, in an attempt to provide clarity, resulted in an equally if not more vague statement of appropriate use. Furthermore, the postmarketing requirement for continued data regarding safety and efficacy have been affirmed by FDA but some of the proposed means to acquire those data will likely result in unclear answers and may have undesired consequences. We fully support the important role of the FDA but raise concerns about the occasional lack of consistency and transparency.
- Gabapentin: can it be misused? [Journal Article]
- J Psychosoc Nurs Ment Health Serv 2014 Jan; 52(1):12-5.
Gabapentin, a gamma-aminobutyric acid analog drug, appears to be safe and efficacious for the treatment of alcohol dependence. Gabapentin is not a controlled drug, but there are anecdotal reports of its misuse and abuse as well as reports of withdrawal symptoms associated with abrupt discontinuation. The risk of gabapentin misuse is inconsistent, the magnitude of the risk is small, and the risk is not comparable to the much higher risks associated with alcohol use; benzodiazepine, opioid, and stimulant drug use; or illicit drug use. Reports of gabapentin misuse are not unique to this drug, as misuse of prescription medications not typically considered "drugs of abuse" can also occur.
- Impact of research network participation on the adoption of buprenorphine for substance abuse treatment. [JOURNAL ARTICLE]
- Addict Behav 2014 Feb 7; 39(5):889-896.
There is a growing body of research supporting the use of buprenorphine and other medication assisted treatments (MATs) for the rapidly accelerating opioid epidemic in the United States. Despite numerous advantages of buprenorphine (accessible in primary care, no daily dosing required, minimal stigma), implementation has been slow. As the field progresses, there is a need to understand the impact of participation in practitioner-scientist research networks on acceptance and uptake of buprenorphine. This paper examines the impact of research network participation on counselor attitudes toward buprenorphine addressing both counselor-level characteristics and program-level variables using hierarchical linear modeling (HLM) to account for nesting of counselors within treatment programs. Using data from the National Treatment Center Study, this project compares privately funded treatment programs (N=345) versus programs affiliated with the National Institute on Drug Abuse Clinical Trials Network (CTN) (N=198). Models included 922 counselors in 172 CTN programs and 1203 counselors in 251 private programs. Results of two-level HLM logistic (Bernoulli) models revealed that counselors with higher levels of education, larger caseloads, more buprenorphine-specific training, and less preference for 12-step treatment models were more likely to perceive buprenorphine as acceptable and effective. Furthermore, buprenorphine was 50% more likely to be perceived as effective among counselors working in CTN-affiliated programs as compared to private programs. This study suggests that research network affiliation positively impacts counselors' acceptance and perceptions of buprenorphine. Thus, research network participation can be utilized as a means to promote positive attitudes toward the implementation of innovations including medication assisted treatment.
- Behavioural treatment combined with buprenorphine does not reduce opioid use compared with buprenorphine alone. [JOURNAL ARTICLE]
- Evid Based Ment Health 2014 Mar 3.
- Opana ER abuse and thrombotic thrombocytopenic purpura (TTP)-like illness: a rising risk factor in illicit drug users. [Journal Article]
- BMJ Case Rep 2014.
We report the case of a 22 year-old-woman who presented with upper extremity cellulitis secondary to an infiltration of illicit intravenous drug use. She confessed to the intravenous use of Opana ER (an extended release oral formulation of oxymorphone) which is an opioid drug approved only for oral use. She was found to have clinical evidence of profound thrombotic microangiopathy which resulted due to the intravenous use of Opana ER. She showed full clinical improvement after withholding drug and supportive clinical care. Recent report of Opana ER intravenous abuse was published from Tennessee county and has now been increasingly recognised as one of the causes of thrombocytopenia which mimicks clinically as thrombotic thrombocytopenic purpura. Physicians should be aware of this association as the lack of familiarity to this can pose serious management dilemmas for our patients (especially the polysubstance abusers).
- High-Risk Use by Patients Prescribed Opioids for Pain and Its Role in Overdose Deaths. [JOURNAL ARTICLE]
- JAMA Intern Med 2014 Mar 3.
IMPORTANCE From January 1, 2003, through December 31, 2010, drug overdose deaths in Tennessee increased from 422 to 1059 per year. More of these deaths involved prescription opioids than heroin and cocaine combined. OBJECTIVE To assess the contribution of certain opioid-prescribing patterns to the risk of overdose death. DESIGN, SETTING, AND PARTICIPANTS We performed a matched case-control study that analyzed opioid prescription data from the Tennessee Controlled Substances Monitoring Program (TNCSMP) from January 1, 2007, through December 31, 2011, to identify risk factors associated with opioid-related overdose deaths from January 1, 2009, through December 31, 2010. Case patients were ascertained from death certificate data. Age- and sex-matched controls were randomly selected from among live patients in the TNCSMP. MAIN OUTCOMES AND MEASURES We defined a high-risk number of prescribers or pharmacies as 4 or more per year and high-risk dosage as a daily mean of more than 100 morphine milligram equivalents (MMEs) per year. The main outcome was opioid-related overdose death. RESULTS From January 1, 2007, through December 31, 2011, one-third of the population of Tennessee filled an opioid prescription each year, and opioid prescription rates increased from 108.3 to 142.5 per 100 population per year. Among all patients in Tennessee prescribed opioids during 2011, 7.6% used more than 4 prescribers, 2.5% used more than 4 pharmacies, and 2.8% had a mean daily dosage greater than 100 MMEs. Increased risk of opioid-related overdose death was associated with 4 or more prescribers (adjusted odds ratio [aOR], 6.5; 95% CI, 5.1-8.5), 4 or more pharmacies (aOR, 6.0; 95% CI, 4.4-8.3), and more than 100 MMEs (aOR, 11.2; 95% CI, 8.3-15.1). Persons with 1 or more risk factor accounted for 55% of all overdose deaths. CONCLUSIONS AND RELEVANCE High-risk use of prescription opioids is frequent and increasing in Tennessee and is associated with increased overdose mortality. Use of prescription drug-monitoring program data to direct risk-reduction measures to the types of patients overrepresented among overdose deaths might reduce mortality associated with opioid abuse.
- Parenting under the influence: The effects of opioids, alcohol and cocaine on mother-child interaction. [JOURNAL ARTICLE]
- Addict Behav 2014 Feb 15; 39(5):897-900.
Nearly 20% of adults receiving treatment for a substance use disorder live with their minor children (Stanger et al., 1999) and women in drug use treatment are twice as likely as men to have children in their household (Wechsberg et al., 1998). Parental drug use impacts the family through reduced family resources such as money and food, and researchers consistently note parenting deficits among substance users (Solis, Shadur, Burns, & Hussong, 2012). Little is known about differences in parenting and mother-child interaction among mothers with different drugs of choice or among mothers of older children, between 8 and 16years. This study reports the findings from a sample of treatment seeking opioid, alcohol and cocaine using mothers and their 8-16-year-old child. Findings from a mother-child observational task and self-reported parenting measure indicated less undermining autonomy and higher mother maternal acceptance among opioid compared to alcohol addicted mothers. African American mothers were observed to have fewer negative interactional behaviors than Whites and both African American mothers and children self-reported higher firm control and maternal acceptance. Overall, mothers appeared to struggle with effective discipline with older versus younger children. Findings offer useful information to clinicians seeking to effectively tailor their interventions to women and children who present with different drugs of abuse, race/culture and developmental stage of child.
- Alanine Analogs of [D-Trp]CJ-15,208: Novel Opioid Activity Profiles and Prevention of Drug- and Stress-Induced Reinstatement of Cocaine-Seeking Behavior. [JOURNAL ARTICLE]
- Br J Pharmacol 2014 Mar 3.
The novel macrocyclic peptide cyclo[Phe-D-Pro-Phe-D-Trp] ([D-Trp]CJ-15,208) exhibits κ opioid receptor (KOR) antagonist activity in both in vitro and in vivo assays. The four alanine analogs of this peptide were synthesized and characterized both in vitro and in vivo to assess the contribution of different amino acid residues to the activity of [D-Trp]CJ-15,208.The peptides were synthesized by a combination of solid-phase peptide synthesis and cyclization in solution. The analogs were evaluated in vitro in receptor binding and functional assays, and in vivo with mice in the 55 (o) C warm water tail withdrawal assay for antinociceptive and opioid antagonist activity. Additional mice demonstrating extinction of cocaine conditioned place preference (CPP) were pretreated with selected analogs to evaluate prevention of stress or cocaine-induced reinstatement of CPP.The alanine analogs displayed pharmacological profiles in vivo that were distinctly different from [D-Trp]CJ,15,208. While the analogs exhibited varying opioid receptor affinities and KOR and MOR antagonist activity in vitro, they produced potent opioid receptor-mediated antinociception (ED50 = 0.28-4.19 nmol, i.c.v.) in vivo; three of the analogs also displayed KOR antagonist activity in vivo. Pretreatment with an analog exhibiting both KOR agonist and antagonist activity in vivo prevented both cocaine- and stress-induced reinstatement of cocaine-seeking behavior in the CPP assay in a time-dependent manner.These unusual macrocyclic peptides exhibit in vivo opioid activity profiles different from the parent compound and represent novel compounds for potential development as therapeutics for drug abuse and possibly as analgesics.
- I heard about it from a friend: assessing interest in buprenorphine treatment. [Journal Article]
- Subst Abus 2014; 35(1):74-9.
Background:In the United States, opioid abuse and dependence continue to be a growing problem, whereas treatment for opioid abuse and dependence remains fairly static. Buprenorphine treatment for opioid dependence is safe and effective but underutilized. Prior research has demonstrated low awareness and use of buprenorphine among marginalized groups. This study investigates syringe exchange participants' awareness of, exposure to, and interest in buprenorphine treatment.
Methods:Syringe exchange participants were recruited from a mobile unit performing outreach to 9 street-side sites in New York City. Computer-based interviews were conducted to determine (1) opioid users' awareness of, exposure to, and interest in buprenorphine treatment; and (2) the association between awareness or exposure and interest in buprenorphine treatment. Logistic regression models were used to examine the associations between awareness of, direct exposure (i.e., having taken buprenorphine) or indirect exposure (i.e., knowing someone who had taken buprenorphine)S to, and interest in buprenorphine treatment.
Results:Of 158 opioid users, 70% were aware of, 32% had direct exposure to, and 31% had indirect exposure to buprenorphine; 12% had been prescribed buprenorphine. Of 138 opioid users who had never been prescribed buprenorphine, 57% were interested in buprenorphine treatment. In multivariate models, indirect exposure was associated with interest in buprenorphine treatment (adjusted odds ratio [AOR] = 2.65, 95% confidence interval [CI]: 1.22-5.77), but awareness and direct exposure were not.
Conclusions:Syringe exchange participants were mostly aware of buprenorphine and interested in treatment, but few had actually been prescribed buprenorphine. Because indirect exposure to buprenorphine was associated with interest in treatment, future interventions could capitalize on indirect exposure, such as through peer mentorship, to address underutilization of buprenorphine treatment.
- Training addiction professionals in empirically supported treatments: perspectives from the treatment community. [Journal Article]
- Subst Abus 2014; 35(1):30-6.