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Bart, G. (2012). Maintenance medication for opiate addiction: The foundation of recovery Journal of Addictive Diseases, 31(3), 207-225. doi: 10.1080/10550887.2012.694598 The purpose was to provide a topical review of the 3 medications approved by FDA for long- term treatment of opiate dependence: methadone, buprenorphine, and naltrexone. Further work is needed to directly compare each medication and determine individual factors that can assist in medication selection. Each of the 3 has superior treatment outcomes to nonmedication-based therapies althousgh methadone and BUP appear superior to oral and intramuscular NTX. A Dreifuss, J.A., Griffin, M.L., et al. (2013). Patient characteristics associated with buprenorphine/naloxone treatment outcome for prescription opioid dependence: Results from a multisite study. Drug and Alcohol Dependence, 131, 112-118. http://0- dx.doi.org.helin.uri.edu/10.1016/j.drugalcdep.2012.12.010 A secondary analysis was performed to examine the baseline characteristics associated with success during 12-week buprenorphine treatment. It was found that a successful outcome generally included older patients with a past-year or lifetime diagnosis of MDD, who initially obtained opioids for pain, only used sublingual or swallowed, never used heroin, used anything other than oxycodone most frequently, and had no prior opioid dependence treatment. This is the first study to examine characteristics associated with treatment outcome on exclusively prescription opioids. Population size was 360. Dunn, K.E, Defulio, A., et al. (2013). Employment-based reinforcement of adherence to oral naltrexone treatment in unemployed injection drug users. Experimental And Clinical Psychopharmacology, 21(1), 74-83. doi:10.1037/a0030743 Previous interventions to improve adherence have included monetary and integrated psychosocial treatments both in the short term. New methods are needed to develop long-term efficacy with the oral treatment as the injection is much more expensive. Foster, B, Twycross, R, et al. (2013). Buprenorphine. Journal of Pain and Symptom Management, 45(5), 939-949. doi: http://0- dx.doi.org.helin.uri.edu/10.1016/j.jpainsymman.2013.03.001 According to this article, there are currently great advances in the management of pain in both cancer and other disorders. The pharmacology of buprenorphine is also discussed. Buprenorphine acts as a partial mu-opioid receptor and opioid-like-receptor agonist as well as a kappa and delta-opioid antagonist. It associates and dissociates slowly. Furst, T.R. (2013). Suboxone Misuse Along the Opiate Maintenance Treatment Pathway. Journal of Addictive Diseases, 32(1), 53-67. doi: 10.1080/10550887.2012.759860 The purpose was to explore strategies employed by Suboxone misusers while in treatment and identify strategies implemented by patients who intermittently use opiates/opioids while in Suboxone treatment. An ethnographic interview with 14 patients with screen for particular characteristics/indicators was performed. It was found that drug diversion (sell pills, strips) is common. The number of deaths is approaching equal to vehicular accident deaths. Stronger treatment is required to eliminate the economic and social costs. Gastfriend, D.R. (2011). Intramuscular extended-release naltrexone (XR-NTX): current evidence. Annals of the New York Academy of Science, 1216(1), 144-166. doi: This article contains information on the development of XR-NTX and its approval for opioid dependence in 2010. The results of the Krupitsky study referenced in the FDA’s approval are discussed. XR-NTX’s use is also examined with stimulants, in combination with psychosocial management, and for the feasibility of its use in the “real world” (Gastfriend, 154). Giuliano, C., Robbins, T.W., et al. (2013). Attenuation of Cocaine and Heroin Seeking by mu- opioid receptor antagonism. Psychopharmacology, 227(1), 137-147. doi: This was a behavioral based animal (rat) study that compared naltrexone v. GSK1521498 (a novel opioid antagonist being investigated with eating behavior). Harrison, T.S., Plosker, G.L., et al. (2006). Extended-release intramuscular naltrexone. Drugs, The purpose of this study was to find ways to improve treatment adherence in patients treated with naltrexone for alcohol dependence. In combination with psychosocial therapy, naltrexone reduced heavy drinking over a 6-month period relative to placebo and was more likely to maintain abstinence. XR-NTX was generally well-tolerated. Factors examined were psychodynamic profile, pharmacokinetic profile, therapeutic efficacy, tolerability, dosage and administration, and current status. Side effects included nausea, injection site reaction, and Krupitsky, E., Nunes, E.V., et al. (2011). Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo controlled, multivariate randomized trial. The Lancet, 377(9776), 1506-1513. http://dx.doi.org/10.1016/S0140-6736(11)60358-9 The purpose here was to assess efficiency, safety, and patient-reported outcomes of an injectable, once monthly extended-release formulation of the opioid antagonist naltrexone (XR-NTX) for treatment of OD patients after detox. A double-blind, placebo controlled, randomized 24-week trial of patients with opioid dependence disorder was employed with participants randomly assigned (1:1) to 380 XR-NTX or placebo. Participants also receive 12 biweekly counseling sessions. The primary endpoint was a response profile for confirmed abstinence during weeks 5- 24 assessed by urine drugs tests and self-report of non-use. A secondary endpoint was self- reported opioid-free days, opioid craving scores, number of days of retention and relapse to physiological opioid dependence. Of 250 participants a 90% median abstinence XR-NTX to 35% placebo was found with self-reported opioid free days at a median of 99.2% compared to 60.4%. Mean change in craving went down by -10.7 compared to 0.7 and median retention of 168 days compared to 96 days. 1 relapse occurred with XR-NTX and 17 in placebo. Each was well-tolerated with only 8 in each group discontinuing due to adverse effects. Lee, J.D., Grossman, E., et al. (2012). Extended-release naltrexone plus medical management alcohol treatment in primary care: Findings at 15 months. Journal of Substance Abuse Treatment, 43(4), 458-462. doi: 10.1016/j.jsat.2012.08.012. The purpose was to determine the feasibility of XR-NTX long-term for alcohol treatment. A 12- week observational trial of XR-NTX plus medical management (MM) in primary care was performed. An additional 48 weeks of XR-NTX treatment (12 additional monthly injections) was also offered. Of 65 alcohol dependent, 40 (62%) completed initial 12 weeks and 19 (29%) continued treatment for a median 38 weeks total. Low self-reported drinking days among extension participants median 0.2 vs. 6.0 drinks/day; 82 v. 38% days abstinent; 11 v. 61% heavy Lin, S. (2013). Pharmacological means of reducing human drug dependence: A selective and narrative review of the clinical literature. British Journal of Clinical Pharmacology, 1- This source includes definitions regarding addiction as well as a review of naltrexone efficacy. Various drugs were also reviewed in terms of the anti-craving effect that they produce. Lobmaier, P., Kornor, H., et al. (2008). Sustained-release Naltrexone for opioid dependence. The Cochrane Library, 3, 53. doi: 10.1002/14651858.CD006140.pub2 The purpose here was to evaluate the effectiveness of sustained-release naltrexone for opioid dependence and its adverse effects in different study populations. To do so databases were searched: MEDLINE, EMBASE, CINHAL ,LILACS, PsychINFO, ISI Web of Science, clinicaltrials.gov. Treatment condition was extended to include alcohol dependent subjects and healthy volunteers. Analyses were performed separately for opioid dependent, alcohol dependent and healthy participants. It was found that of 2 dosages of NTX injections (192 and 384 mg) compared to placebo, high-dose significantly increased days in treatment compared to placebo, high-dose compared to low-dose significantly increased days in treatment, number of patients retained in treatment didn’t show significant differences between groups. Adverse effects (17 – 6 were RCTs) were more frequent in naltrexone groups compared to placebo. In alcohol dependent samples, more frequent in low-dose. And in OD, not significant. Mark, T.L., Kassed, C.A., et al. (2008). Alcohol and Opioid Dependence Medication: Prescription trends, overall and by physician specialty. Drug and Alcohol Dependence. 99(1), 345-349. http://0-dx.doi.org.helin.uri.edu/10.1016/j.drugalcdep.2008.07.018 Includes a table demonstrating the growth of different medication distribution from 2003-2007. Mooney, L.J., Nielsen, S., et al. (2013). Cocaine use reduction with buprenorphine (CURB): Rationale, design, and methodology. Contemporary Clinical Trials, 34(2), 196-204. http://0-dx.doi.org.helin.uri.edu/10.1016/j.cct.2012.11.002 Effective medications to treat cocaine dependence haven’t been identified. The purpose here was to examine efficacy and safety of sublingual BUP in presence of XR-NTX for cocaine dependence. A multi-site (11) placebo-controlled double-blind (N=300) study was performed. XR-NTX was employed after 7 days abstinence followed by oral naltrexone then 1 of 3 possible conditions for 8 weeks, and a follow-up with CBT. This study is currently ongoing. Nielsen, S., Hillhouse, M., et al. (2012). Comparing Buprenorphine induction experience with heroin and prescription opioid users. Journal of Substance Abuse Treatment, 43(3), 285- 290. http://0-dx.doi.org.helin.uri.edu/10.1016/j.jsat.2011.12.009, Prescription opioid use is more common but most research on treatment of opioid dependent populations has been conducted in heroin users. The purpose here was to compare through secondary data analysis, the BUP induction experience of 167 heroin and 61 PO users through ASI, Visual Analog Craving Scales (VAS), clinical opiate withdrawal scale (COWS) Beck Depression Inventory (BDI), short form-36 health survey, dose log and demographics (gender, age, ethnicity/race, education, employment pattern, marital status). It was found that although some baseline characteristics differ, many of the key induction variables were comparable between the groups. No differences were found for self-reported craving and withdrawal scores, mean buprenorphine dose on day 1, or retention at end of the first week. Existing BUP induction practices developed for heroin users appear to be equally effective with PO users. Reece, A.S. (2009). Comparative treatment and mortality correlates and adverse event profile of implant naltrexone and sublingual buprenorphine. Journal of Substance Abuse Treatment, 37(3), 256-265. doi: 10.1016/j.jsat.2009.03.008 The purpose was to review treatment correlates of previously prevented mortality data and of adverse events as result of increasing interest in use of XR-NTX. Groups of N=255 NTX and N=2,518 BUP were followed for 1,322.22 and 8,030.02 patient-years respectively. It was found that NTX patients had significantly longer days in treatment per episode, total treatment duration, and mean treatment times, but fewer treatment episodes than BUP. Local tissue reaction occurred in 1% of 200 NTX episodes. In conclusion, NTX economizes treatment resources without compromising safety concerns. Sigmon, S.C., Dunn, K.E., et al. Brief buprenorphine detoxification for treatment of prescription opioid dependence: A pilot study. Addictive Behaviors, 34(3), 304-311. http://0- dx.doi.org.helin.uri.edu/10.1016/j.addbeh.2008.11.017 The purpose here was to determine the feasibility of brief outpatient detoxification as treatment for prescription opioid (PO) abusers. Dosing was given in a double-blind, double-dummy manner of BUP/naloxone and a color-matched placebo, both sublingual. 15 adults enrolled for BUP stabilization, 2-week BUP taper, and subsequent naltrexone once the taper was completed. They also received behavioral therapy, urinalysis monitoring, and double-blind drug administration. It was found that 83.8%, 91.7% and 31.2% had opioid-negative samples during stablilization, taper, and naltrexone phases, respectively. Post-hoc analyses examined characteristics of subjects who successfully completed the taper (n=5) versus those who failed (n=9). This suggests that PO abusers may respond to brief BUP detox. Sullivan, M.A., Garawi, F., et al. (2007). Management of relapse in naltrexone maintenance for heroin dependence. Drug and Alcohol Dependence, 91(2-3), 289-292. http://0- dx.doi.org.helin.uri.edu/10.1016/j.drugalcdep.2007.06.013 The purpose was to identify critical determinants of relapses to opioid use during naltrexone maintenance. Time retained in treatment was examined as a function of whether lapses occurred while adherent to naltrexone (blocked use) or after having missed dose (unblocked). There was a population of N =83 DSM-IV positive for OD participants who also had a significant other participating in treatment. Following inpatient detoxification, each was enrolled in a 26-week outpatient course of therapy and naltrexone maintenance. It was found that unblocked use had a high rate of dropout (10% retained at 6 months) dropout occurring within 2 weeks after unblocked use. Only blocked had less dropout (33% retained at 6 months). Episodes of blocked use were often followed by unblocked use and dropout. Extended release may help overcome Swift, R., Oslin, D., Alexander, M., & Forman, R. (2011). Adherence monitoring in naltrexone pharmacotherapy trials: a systematic review. Journal Of Studies On Alcohol And Drugs, Comprehensive Review of efficacy trials using Vivitrol. Includes sources for 4 reviewed meta- The Betty Ford Institute Consensus Panel. (2007). What is recovery? A Working definition from the Betty Ford Institute. Journal of Substance Abuse Treatment, 33(3), 221-228. doi: “Recovery from substance dependence is a voluntarily-maintaned lifestyle characterized by sobriety, personal health and citizenship” (222). The consensus panel decided on a final definition and a list of questions to determine one’s condition post treatment. Thomas, C.P., Garnick, D.W., et al. (2013). Establishing the feasibility of measuring performance in use of addiction pharmacotherapy. Journal of Substance Abuse Treatment, 45(1), 11-18. http://0-dx.doi.org.helin.uri.edu/10.1016/j.jsat.2013.01.004 The purpose was to present rationale and feasibility of standardized performance measures for use of a pharmacotherapy in treatment of substance use disorders (SUD). Methods involved designing and standardized performance measures for use with SUD. Pharmacotherapy was applied in national data across a disparate set of covered populations Tkacz, J., Severt, J., et al. (2012). Compliance with buprenorphine medication-assisted treatment and relapse to opioid use. American Journal on Addictions, 21(1), 55-62. doi: The purpose was to determine the effect of compliance with buprenorphine on reducing relapse among sample of patients in treatment for opioid dependency. Those new to BUP (N=703) completed the Addiction Severity Index at baseline and 1-3 weeks post baseline. Compliance was defined as taking BUP 22/28 days (80%) and relapse was defined as resumed use of opioids during follow-up (months 2 and 3). It was found that noncompliant patients were over 1o times more likely to relapse than those who were compliant. Neither demographics nor base ASI Woody, G.E., Poole, S.A., et al. (2011). Extended versus short-term Buprenorphine-Naloxone for treatment of opioid-addicted youth: A randomized trial. Journal of American Medical Association, 300(17), 2057-2059. doi: 10.1001/jama.2008.574 The purpose was to evaluate efficacy of continuing buprenorphine-naloxone for 12 weeks versus detoxification for opioid-addicted youth. A clinical trial was performed at 6 community programs with N=152, 15-21 years old. Trials were randomized to 12 weeks of BUP-Nal or a 14 day taper detox. Patients in 12 week prescribed up to 24 mg/day for 9 weeks then tapered to week 12. Detox group was prescribed up to 14 mg/day then tapered to day 14. All were offered weekly individual and group counseling. Outcome was measured by opioid urine tests during weeks 4,8, and 12. Overall, it was found that patients had higher opioid-positive test results at weeks 4 and 8 but not 12. Week 4: 59 detox v. 58 12-week. Week 12: 16 of 78 detox remained in treatment v. 52 of 74 12-week BUP. Week 1-12: 12-week reported less opioid use, less injecting, and less nonstudy addiction treatment. Continued treatment improved compared to (2010). FDA Moves Closer to Approving Vivitrol for Opioid Dependence. Alcoholism and The FDA is concerned about culture differences between Russia and the US as the only study referenced for approval was performed in Russia. (2011). FDA Says OK to give Vivitrol or Suboxone Without Counseling. Alcoholism and Drug Abuse Weekly, 23. 4-5. doi: 10.1002/adaw Trials that led to approval of using both medications occurred with counseling, however, the decision to use counseling in tandem with the medication is “considered practice of medicine, FDA doesn’t regulate practice of medicine”.

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