Richard N. Rosenthal

Buprenorphine Implants for Treatment of Opioid Dependence: A Randomized Controlled Trial

CONTEXT Limitations of existing pharmacological treatments for opioid dependence include low adherence, medication diversion, and emergence of withdrawal symptoms. OBJECTIVE To determine the efficacy of buprenorphine implants that provide a low, steady level of buprenorphine over 6 months for the treatment of opioid dependence. DESIGN, SETTING, AND PARTICIPANTS A randomized, placebo-controlled, 6-month trial conducted at 18 sites in the United States between April 2007 and June 2008. One hundred sixty-three adults, aged 18 to 65 years, diagnosed with opioid dependence. One hundred eight were randomized to receive buprenorphine implants and 55 to receive placebo implants. INTERVENTION After induction with sublingual buprenorphine-naloxone tablets, patients received either 4 buprenorphine implants (80 mg per implant) or 4 placebo implants. A fifth implant was available if a threshold for rescue use of sublingual buprenorphine-naloxone treatment was exceeded. Standardized individual drug counseling was provided to all patients. MAIN OUTCOME MEASURE The percentage of urine samples negative for illicit opioids for weeks 1 through 16 and for weeks 17 through 24. RESULTS The buprenorphine implant group had significantly more urine samples negative for illicit opioids during weeks 1 through 16 (P = .04). Patients with buprenorphine implants had a mean percentage of urine samples that tested negative for illicit opioids across weeks 1 through 16 of 40.4% (95% confidence interval [CI], 34.2%-46.7%) and a median of 40.7%; whereas those in the placebo group had a mean of 28.3% (95% CI, 20.3%-36.3%) and a median of 20.8%. A total of 71 of 108 patients (65.7%) who received buprenorphine implants completed the study vs 17 of 55 (30.9%) who received placebo implants (P < .001). Those who received buprenorphine implants also had fewer clinician-rated (P <.001) and patient-rated (P = .004) withdrawal symptoms, had lower patient ratings of craving (P <.001), and experienced a greater change on clinician global ratings of severity of opioid dependence (P<.001) and on the clinician global ratings of improvement (P < .001) than those who received placebo implants. Minor implant site reactions were the most common adverse events: 61 patients (56.5%) in the buprenorphine group and 29 (52.7%) in the placebo group. CONCLUSION Among persons with opioid dependence, the use of buprenorphine implants compared with placebo resulted in less opioid use over 16 weeks as assessed by urine samples. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00447564.

Implications of Epidemiological Data for Identifying Persons with Substance Use and Other Mental Disorders

The authors conducted systematic searches in standard databases using key search terms related to epidemiology, prevalence, and co-occurring substance use and other mental disorders (COD), as well as specific combinations of drug and mental disorders. The authors targeted high-quality, large sample epidemiological surveys so as to utilize studies of high methodological rigor in the construction of recommendations for clinical identification. Further refined searches to identify these studies revealed common themes and related research gaps. Findings suggest that clinicians should have increased expectation that a patient with a substance use disorder (SUD) has a co-occurring mental disorder if the SUD is relatively severe, if the patient began using substances (including tobacco) at an early age, is female, is dependent on nicotine, or has a drug use disorder. Patients identified as having at least one SUD and one co-occurring mental disorder should be assessed to identify other likely CODs, because disorders are not normally distributed and tend to cluster in relatively few individuals.

Basic Treatment Techniques for Persons with Mental Disorders and Co-occurring Substance Use Disorders

Chapter 23 details the psychopharmacology and psychosocial evidence base for treating co-occurring of mental illness and substance use disorders (COD).This chapter focuses on a basic level of practice: basic techniques that underlie the common clinical approaches that community psychiatrists and other clinicians use in treating patients with COD. This focus on technique does not describe new interventions for COD, or describe standard treatment approaches, but rather offers a clinically oriented way for clinicians to think about them, so that there is a menu from which they might be more easily implemented.

Does a History of Alcohol Use Disorder Affect Response to Antidepressant Medication in Patients With Dysthymic Disorder

ABSTRACT Background: Research on the relationship between depression and alcohol use disorder in remission has been scarce. The authors examined whether a lifetime history of alcohol use disorder affected response to antidepressant treatment of dysthymic disorder (DD) in adult outpatients. Methods: This is a secondary analysis of data from previous prospective medication trials. Data from 123 subjects with DD were included. Subjects were categorized into 2 groups: (1) no lifetime alcohol use disorder (NLAUD) (n = 99) and (2) lifetime alcohol use disorder (LAUD) (n = 24). None of the subjects met criteria for alcohol use disorder for 6 months prior to intake. Rating scales from baseline and after 8 weeks of pharmacotherapy were collected. Results: After 8 weeks of treatment, the NLAUD and LAUD groups did not differ in rates of response or remission, despite significantly higher baseline Hamilton Depression Rating Scale (HDRS)-24 scores in the LAUD group. We also found a greater decrease in symptoms in the LAUD group, as measured by the HDRS-24. Conclusions: Our preliminary findings suggest that DD in remitted alcoholics is at least as responsive to pharmacotherapy as DD in nonalcoholics and support adequate evaluation and treatment of DD in remitted alcoholic patients.