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Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders

Lee, Joshua D; Friedmann, Peter D; Kinlock, Timothy W; Nunes, Edward V; Boney, Tamara Y; Hoskinson, Randall A Jr; Wilson, Donna; McDonald, Ryan; Rotrosen, John; Gourevitch, Marc N; Gordon, Michael; Fishman, Marc; Chen, Donna T; Bonnie, Richard J; Cornish, James W; Murphy, Sean M; O'Brien, Charles P
BACKGROUND: Extended-release naltrexone, a sustained-release monthly injectable formulation of the full mu-opioid receptor antagonist, is effective for the prevention of relapse to opioid dependence. Data supporting its effectiveness in U.S. criminal justice populations are limited. METHODS: In this five-site, open-label, randomized trial, we compared a 24-week course of extended-release naltrexone (Vivitrol) with usual treatment, consisting of brief counseling and referrals for community treatment programs, for the prevention of opioid relapse among adult criminal justice offenders (i.e., persons involved in the U.S. criminal justice system) who had a history of opioid dependence and a preference for opioid-free rather than opioid maintenance treatments and who were abstinent from opioids at the time of randomization. The primary outcome was the time to an opioid-relapse event, which was defined as 10 or more days of opioid use in a 28-day period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use. Post-treatment follow-up occurred at weeks 27, 52, and 78. RESULTS: A total of 153 participants were assigned to extended-release naltrexone and 155 to usual treatment. During the 24-week treatment phase, participants assigned to extended-release naltrexone had a longer median time to relapse than did those assigned to usual treatment (10.5 vs. 5.0 weeks, P<0.001; hazard ratio, 0.49; 95% confidence interval [CI], 0.36 to 0.68), a lower rate of relapse (43% vs. 64% of participants, P<0.001; odds ratio, 0.43; 95% CI, 0.28 to 0.65), and a higher rate of opioid-negative urine samples (74% vs. 56%, P<0.001; odds ratio, 2.30; 95% CI, 1.48 to 3.54). At week 78 (approximately 1 year after the end of the treatment phase), rates of opioid-negative urine samples were equal (46% in each group, P=0.91). The rates of other prespecified secondary outcome measures--self-reported cocaine, alcohol, and intravenous drug use, unsafe sex, and reincarceration--were not significantly lower with extended-release naltrexone than with usual treatment. Over the total 78 weeks observed, there were no overdose events in the extended-release naltrexone group and seven in the usual-treatment group (P=0.02). CONCLUSIONS: In this trial involving criminal justice offenders, extended-release naltrexone was associated with a rate of opioid relapse that was lower than that with usual treatment. Opioid-use prevention effects waned after treatment discontinuation. (Funded by the National Institute on Drug Abuse; ClinicalTrials.gov number, NCT00781898.).
PMCID:5454800
PMID: 27028913
ISSN: 1533-4406
CID: 2079662

Validation of an audio computer assisted self interview (ACASI) version of the alcohol, smoking and substance involvement screening test (ASSIST) in primary care patients

McNeely, Jennifer; Strauss, Shiela M; Rotrosen, John; Ramautar, Arianne; Gourevitch, Marc N
BACKGROUND AND AIMS: To address barriers to implementing the "Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)" in medical settings, we adapted the traditional interviewer-administered (IA) ASSIST to an audio-guided computer assisted self-interview (ACASI) format. This study sought to validate the ACASI ASSIST by estimating the concordance, correlation, and agreement of scores generated using the ACASI versus the reference standard IA ASSIST. Secondary aims were to assess feasibility and compare ASSIST self-report to drug testing results. DESIGN: Participants completed the ACASI and IA ASSIST in a randomly assigned order, followed by drug testing. SETTING: Urban safety-net primary care clinic in New York City, USA. PARTICIPANTS: A total of 393 adult patients. MEASUREMENTS: Scores generated by the ACASI and IA ASSIST; drug testing results from saliva and hair samples. FINDINGS: Concordance between the ACASI and IA ASSIST in identifying moderate-high risk use was 92-99% for each substance class. Correlation was excellent for global scores (ICC = 0.94, CI 0.92-0.95) and for substance-specific scores for tobacco (ICC = 0.93, CI 0.91-0.94), alcohol (ICC = 0.91, CI 0.89-0.93) and illicit drugs (ICC = 0.85, CI 0.85-0.90), and good for prescription drugs (ICC = 0.68, CI 0.61-0.73). Ninety-four percent of differences in global scores fell within anticipated limits of agreement. Among participants with a positive saliva test, 74% self-reported use on the ACASI ASSIST. The ACASI ASSIST required a median time of 3.7 minutes (range 0.7-15.4), and 21 (5.3%) participants requested assistance. CONCLUSIONS: The computer self-administered Alcohol, Smoking and Substance Involvement Screening Test appears to be a valid alternative to the interviewer-administered approach for identifying substance use in primary care patients.
PMCID:4899945
PMID: 26360315
ISSN: 1360-0443
CID: 1772682

Classic hallucinogens in the treatment of addictions

Bogenschutz, Michael P; Johnson, Matthew W
Addictive disorders are very common and have devastating individual and social consequences. Currently available treatment is moderately effective at best. After many years of neglect, there is renewed interest in potential clinical uses for classic hallucinogens in the treatment of addictions and other behavioral health conditions. In this paper we provide a comprehensive review of both historical and recent clinical research on the use of classic hallucinogens in the treatment of addiction, selectively review other relevant research concerning hallucinogens, and suggest directions for future research. Clinical trial data are very limited except for the use of LSD in the treatment of alcoholism, where a meta-analysis of controlled trials has demonstrated a consistent and clinically significant beneficial effect of high-dose LSD. Recent pilot studies of psilocybin-assisted treatment of nicotine and alcohol dependence had strikingly positive outcomes, but controlled trials will be necessary to evaluate the efficacy of these treatments. Although plausible biological mechanisms have been proposed, currently the strongest evidence is for the role of mystical or other meaningful experiences as mediators of therapeutic effects. Classic hallucinogens have an excellent record of safety in the context of clinical research. Given our limited understanding of the clinically relevant effects of classic hallucinogens, there is a wealth of opportunities for research that could contribute important new knowledge and potentially lead to valuable new treatments for addiction.
PMID: 25784600
ISSN: 0278-5846
CID: 1506192

Glutamatergic and GABAergic susceptibility loci for heroin and cocaine addiction in subjects of African and European ancestry

Levran, Orna; Peles, Einat; Randesi, Matthew; Correa da Rosa, Joel; Ott, Jurg; Rotrosen, John; Adelson, Miriam; Kreek, Mary Jeanne
BACKGROUND: Drug addiction, a leading health problem, is a chronic brain disease with a significant genetic component. Animal models and clinical studies established the involvement of glutamate and GABA neurotransmission in drug addiction. This study was designed to assess if 258 variants in 27 genes of these systems contribute to the vulnerability to develop drug addiction. METHODS: Four independent analyses were conducted in a sample of 1860 subjects divided according to drug of abuse (heroin or cocaine) and ancestry (African and European). RESULTS: A total of 11 SNPs in eight genes showed nominally significant associations (P<0.01) with heroin and/or cocaine addiction in one or both ancestral groups but the associations did not survive correction for multiple testing. Of these SNPs, the GAD1 upstream SNP rs1978340 is potentially functional as it was shown to affect GABA concentrations in the cingulate cortex. In addition, SNPs GABRB3 rs7165224; DBI rs12613135; GAD1 SNPs rs2058725, rs1978340, rs2241164; and GRIN2A rs1650420 were previously reported in associations with drug addiction or related phenotypes. CONCLUSIONS: The study supports the involvement of genetic variation in the glutamatergic and GABAergic systems in drug addiction with partial overlap in susceptibility loci between cocaine and heroin addiction.
PMCID:4564302
PMID: 26277529
ISSN: 1878-4216
CID: 1768602

Pharmacy Intervention to Improve HIV Testing Uptake Using a Comprehensive Health Screening Approach

Crawford, Natalie D; Dean, Trevano; Rivera, Alexis V; Guffey, Taylor; Amesty, Silvia; Rudolph, Abby; DeCuir, Jennifer; Fuller, Crystal M
OBJECTIVE: HIV testing is increasingly available, yet barriers to HIV testing persist for low-income black and Latino people, especially those who use illicit drugs. HIV exceptionalism, or the idea that a positive HIV diagnosis is drastically different from a diagnosis for any other disease, may influence HIV testing-related stigma, resulting in reduced willingness to undergo HIV testing. This pharmacy-based intervention combined HIV testing with less stigmatized chronic disease screening tests (e.g., blood pressure, glucose, and cholesterol) to equate the concept of an HIV diagnosis with other diagnoses. METHODS: Three pharmacies located in low-income, minority neighborhoods in New York City were enrolled in an intervention to provide (1) HIV testing, chronic disease screening, and a healthy lifestyles video that normalized all screening tests and destigmatized HIV as a fatal disease (comprehensive arm); (2) HIV testing and the video (video arm); and (3) HIV testing only (control arm). Injection drug users (IDUs) and pharmacy staff recruited un- and underinsured pharmacy customers, IDUs, and IDU peers from 2010 to 2012. Participants in the control group were compared with those in the comprehensive and video intervention groups. RESULTS: Participants in the comprehensive arm (prevalence ratio [PR] = 1.61, 95% confidence interval [CI] 1.03, 2.49, p=0.08) and the video arm (PR=1.59, 95% CI 1.00, 2.53, p=0.09) were marginally significantly more likely to receive an HIV test in the pharmacy compared with those in the control arm after adjustment. CONCLUSIONS: These findings suggest that adoption of strategies that destigmatize and normalize HIV testing can improve uptake. Implementation of this strategy in low-access, minority communities with high HIV prevalence and among high-risk populations may help reduce racial/ethnic disparities in HIV.
PMCID:4720615
PMID: 26862239
ISSN: 1468-2877
CID: 1937092

EXTENDED-RELEASE NALTREXONE VERSUS ORAL NALTREXONE FOR ALCOHOL USE DISORDER TREATMENT IN PRIMARY CARE [Meeting Abstract]

Chen, J; Obi, R; Wong, S; Flannery, M; McDonald, R; Tofighi, B; Kermack, A; Laska, E; Rotrosen, J; Gourevitch, MN
ISI:000379814601870
ISSN: 1530-0277
CID: 2219942

Expanding the Pipeline: The New York University School of Medicine-University of Ghana School of Medicine and Dentistry Psychiatric Education Initiative

Vaughn, Rubiahna L; Smith, Lianne Morris; Bernstein, Carol A; Hansen, Helena; Ofori-Atta, Angela; Ohene, Sammy
As many low- and middle-income countries (LAMICs), Ghana is affected by a severe shortage of mental health specialists: there are 11 practicing psychiatrists for a population of 25 million. The pipeline for Ghanaian psychiatrists remains restricted for the foreseeable future given the low expressed interest in the field by junior medical trainees. The few senior psychiatric specialists are overextended with clinical and professional duties leaving them with minimal time to teach and mentor trainees. This limits opportunities for mentorship, modeling, teaching, and curricular development, leaving trainees with little exposure to psychiatric practice, and therefore, little motivation to enter a highly stigmatized and underresourced field. To support the training of Ghanaian medical students in psychiatry, the New York University School of Medicine-University of Ghana School of Medicine and Dentistry (NYUSOM-UGSMD) Psychiatric Education Initiative, and the NYU Global Mental Health Elective were formed (1) to provide educational support to medical students and residents at UGSMD and (2) to provide a sustainable international experience for NYUSOM residents with a strong interest in leadership in global mental health and underserved populations.
PMCID:5673107
PMID: 29118456
ISSN: 0020-7411
CID: 2771832

The RESCueH Programme: Testing New Non-Pharmacologic Interventions for Alcohol Use Disorders: Rationale and Methods

Sogaard Nielsen, Anette; Nielsen, Bent; Andersen, Kjeld; Roessler, Kirsten Kaya; Buhringer, Gerhard; Bogenschutz, Michael; Ekstrom, Claus Thorn; Sogaard, Jes
Excessive alcohol consumption is one of the most important lifestyle factors affecting the disease burden in the Western world. The results of treatment in daily practice are modest at best. The aim of the RESCueH programme is to develop and evaluate methods, which are as practice-near as possible, and therefore can be implemented quickly and easily in everyday clinical practice. It is the first clinical alcohol programme to be transatlantic in scope, with implementation in treatment centers located in Denmark, Germany and the US. The RESCueH programme comprises 5 randomized controlled trials, and the studies can be expected to result in (1) more patients starting treatment in specialized outpatient clinics, (2) a greater number of elderly patients being treated, (3) increased patient motivation for treatment and thus improved adherence, (4) more patients with stable positive outcomes after treatment and (5) fewer patients relapsing into harmful drinking. The aim of this paper is to discuss the rationale for the RESCueH programme, to present the studies and expected results.
PMID: 27434091
ISSN: 1421-9891
CID: 2301002

Cocaine and HIV infection

Chapter by: Cardozo, Timothy; Shmelkov, Sergey V; Carr, Kenneth; Rotrosen, John, Mateu-Gelabert, Pedro; Friedman, Samuel R
in: Biologics to treat substance use disorders : vaccines, monoclonal antibodies, and enzymes by Montoya, Ivan D (Ed)
Cham : Springer, 2016
pp. 75-103
ISBN: 3319231502
CID: 4842782

Validation of Self-Administered Single-Item Screening Questions (SISQs) for Unhealthy Alcohol and Drug Use in Primary Care Patients

McNeely, Jennifer; Cleland, Charles M; Strauss, Shiela M; Palamar, Joseph J; Rotrosen, John; Saitz, Richard
BACKGROUND: Very brief single-item screening questions (SISQs) for alcohol and other drug use can facilitate screening in health care settings, but are not widely used. Self-administered versions of the SISQs could ease barriers to their implementation. OBJECTIVE: We sought to validate SISQs for self-administration in primary care patients. DESIGN: Participants completed SISQs for alcohol and drugs (illicit and prescription misuse) on touchscreen tablet computers. Self-reported reference standard measures of unhealthy use, and more specifically of risky consumption, problem use, and substance use disorders, were then administered by an interviewer, and saliva drug tests were collected. PARTICIPANTS: Adult patients aged 21-65 years were consecutively enrolled from two urban safety-net primary care clinics. MAIN MEASURES: The SISQs were compared against reference standards to determine sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) for alcohol and drug use. KEY RESULTS: Among the 459 participants, 22 % reported unhealthy alcohol use and 25 % reported drug use in the past year. The SISQ-alcohol had sensitivity of 73.3 % (95 % CI 65.3-80.3) and specificity of 84.7 % (95 % CI 80.2-88.5), AUC = 0.79 (95 % CI 0.75-0.83), for detecting unhealthy alcohol use, and sensitivity of 86.7 % (95 % CI 75.4-94.1) and specificity of 74.2 % (95 % CI 69.6-78.4), AUC = 0.80 (95 % CI 0.76-0.85), for alcohol use disorder. The SISQ-drug had sensitivity of 71.3 % (95 % CI 62.4-79.1) and specificity of 94.3 % (95 % CI 91.3-96.6), AUC = 0.83 (95 % CI 0.79-0.87), for detecting unhealthy drug use, and sensitivity of 85.1 (95 % CI 75.0-92.3) and specificity of 88.6 % (95 % CI 85.0-91.6), AUC = 0.87 (95 % CI 0.83-0.91), for drug use disorder. CONCLUSIONS: The self-administered SISQs are a valid approach to detecting unhealthy alcohol and other drug use in primary care patients. Although self-administered SISQs may be less accurate than the previously validated interviewer-administered versions, they are potentially easier to implement and more likely to retain their fidelity in real-world practice settings.
PMCID:4636560
PMID: 25986138
ISSN: 1525-1497
CID: 1595062