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Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial

Ross, Stephen; Bossis, Anthony; Guss, Jeffrey; Agin-Liebes, Gabrielle; Malone, Tara; Cohen, Barry; Mennenga, Sarah E; Belser, Alexander; Kalliontzi, Krystallia; Babb, James; Su, Zhe; Corby, Patricia; Schmidt, Brian L
BACKGROUND: Clinically significant anxiety and depression are common in patients with cancer, and are associated with poor psychiatric and medical outcomes. Historical and recent research suggests a role for psilocybin to treat cancer-related anxiety and depression. METHODS: In this double-blind, placebo-controlled, crossover trial, 29 patients with cancer-related anxiety and depression were randomly assigned and received treatment with single-dose psilocybin (0.3 mg/kg) or niacin, both in conjunction with psychotherapy. The primary outcomes were anxiety and depression assessed between groups prior to the crossover at 7 weeks. RESULTS: Prior to the crossover, psilocybin produced immediate, substantial, and sustained improvements in anxiety and depression and led to decreases in cancer-related demoralization and hopelessness, improved spiritual wellbeing, and increased quality of life. At the 6.5-month follow-up, psilocybin was associated with enduring anxiolytic and anti-depressant effects (approximately 60-80% of participants continued with clinically significant reductions in depression or anxiety), sustained benefits in existential distress and quality of life, as well as improved attitudes towards death. The psilocybin-induced mystical experience mediated the therapeutic effect of psilocybin on anxiety and depression. CONCLUSIONS: In conjunction with psychotherapy, single moderate-dose psilocybin produced rapid, robust and enduring anxiolytic and anti-depressant effects in patients with cancer-related psychological distress. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00957359.
PMCID:5367551
PMID: 27909164
ISSN: 1461-7285
CID: 2329512

Qualitative and quantitative feedback following workshop training in evidence-based practices: A dissemination study

Houck, Jon M; Forcehimes, Alyssa A; Davis, Meredith M A; Bogenschutz, Michael P
PMCID:5176331
PMID: 28018028
ISSN: 0735-7028
CID: 3096102

Is the Prescription Opioid Epidemic a White Problem?

Hansen, Helena; Netherland, Julie
PMCID:5105018
PMID: 27831792
ISSN: 1541-0048
CID: 2360702

Individual and Neighborhood Characteristics Associated with HIV Among Black and Latino Adults Who Use Drugs and Unaware of Their HIV-Positive Status, New York City, 2000-2004

Lewis, Crystal Fuller; Rivera, Alexis V; Crawford, Natalie D; Gordon, Kirsha; White, Kellee; Vlahov, David; Galea, Sandro
With mounting evidence of how neighborhood socioeconomic context influences individual behavior, investigation of neighborhood social context and sex/drug use risk behavior could help explain and provide insight into solutions to solve persistent racial disparities in HIV. Interviewer-administered surveys and HIV testing among street-recruited individuals who reported illicit drug use in New York City were conducted from 2000 to 2004. Individuals were geocoded to census tracts, and generalized estimating equations were used to determine correlates of being newly diagnosed with HIV at study enrollment. Analyses were completed in 2014. Of the 920 participants, 10.5 % were HIV-positive, and among those, 45 % were diagnosed at study enrollment. After restricting the sample to those who self-reported negative HIV status (n = 867), 72 % were male, 65 % Latino, and 5.1 % tested HIV-positive. After adjustment, those testing HIV-positive were more likely to report male same-sex partnership (p < 0.01) and less likely to be homeless compared with those confirmed HIV-negative (p < 0.01). Neighborhood-adjusted models indicated those from neighborhoods with less deprivation (p < 0.05), and a higher proportion of owner-occupied homes (p < 0.01) were more likely to test HIV-positive. Additionally, Black individuals who used drugs and were from neighborhoods with a higher proportion of Black residents were more likely to be newly diagnosed compared to Latino individuals who used drugs and were from neighborhoods with lower proportions of Black residents (p < 0.05). These data suggest that HIV prevention and treatment efforts should continue widening its reach to those unaware of their HIV infection, namely men who have sex with men, heavy, drug-involved Black communities, and both Black and Latino communities from relatively less disadvantaged neighborhoods.
PMID: 27294761
ISSN: 2196-8837
CID: 2144982

Psychological and neuropsychological assessment of regular hoasca users

Barbosa, Paulo Cesar Ribeiro; Strassman, Rick J; da Silveira, Dartiu Xavier; Areco, Kelsy; Hoy, Robert; Pommy, Jessica; Thoma, Robert; Bogenschutz, Michael
BACKGROUND:Hoasca (also called ayahuasca) is a N,N-dimethyltryptamine (DMT) - containing psychedelic brew originally used for magico-religious purposes by Amerindian populations of the Amazon Basin. Recently, Brazilian syncretic churches have helped spread the ritual use of hoasca to Western societies. The aim of this study was to evaluate substance use, and neuropsychological and psychological functioning of regular hoasca users within a religious setting. METHODS:Assessment of socio-economic status, mood, personality traits, impulsiveness, drug use, quality of life, extrinsic and intrinsic religiosity, and neuropsychological function was performed on 30 volunteers from a U.S. branch of União do Vegetal (UDV), a Brazilian religion which uses hoasca ritually. We also assessed 27 non-hoasca-using control subjects matched by socio-demographic profile and church attendance. Mann-Whitney U, chi-squared and Fisher tests were used to analyze differences between groups. Spearman's association and simple logistic regression tests were used to analyze the impact of frequency of hoasca use on dependent variables. RESULTS:=.39) and negatively associated with lifetime heavy alcohol use (p=0.034, OR=0.979). CONCLUSIONS:The findings indicate that religious use of hoasca does not adversely affect neuropsychological functioning and may have positive effects on substance abuse and mood.
PMID: 27653781
ISSN: 1532-8384
CID: 5069522

Ethical and clinical safety considerations in the design of an effectiveness trial: A comparison of buprenorphine versus naltrexone treatment for opioid dependence

Nunes, Edward V; Lee, Joshua D; Sisti, Dominic; Segal, Andrea; Caplan, Arthur; Fishman, Marc; Bailey, Genie; Brigham, Gregory; Novo, Patricia; Farkas, Sarah; Rotrosen, John
We examine ethical challenges encountered in the design of an effectiveness trial (CTN-0051; X:BOT), comparing sublingual buprenorphine-naloxone (BUP-NX), an established treatment for opioid dependence, to the newer extended-release injectable naltrexone (XR-NTX). Ethical issues surrounded: 1) known poor effectiveness of one possible, commonly used treatment as usual control condition-detoxification followed by counseling without medication; 2) the role of patients' preferences for treatments, given that treatments were clinically approved and available to the population; 3) differences between the optimal "usual treatment" clinical settings for different treatments making it challenging to design a fair comparison; 4) vested interest groups favoring different treatments exerting potential influence on the design process; 5) potentially vulnerable populations of substance users and prisoners; 6) potential therapeutic misconception in the implementation of safety procedures; and 7) high cost of a large trial limiting questions that could be addressed. We examine how the design features underlying these ethical issues are characteristic of effectiveness trials, which are often large trials that compare treatments with varying degrees of existing effectiveness data and familiarity to patients and clinicians, in community-based treatment settings, with minimal exclusion criteria that could involve vulnerable populations. Hence, investigators designing effectiveness trials may wish to remain alert to the possibility of similar ethical issues.
PMCID:5466164
PMID: 27687743
ISSN: 1559-2030
CID: 2262712

Corrigendum to "Extended-release naltrexone opioid treatment at jail reentry (XOR)" [Contemp. Clin. Trials 49 (2016) 57-64] [Correction]

McDonald, Ryan D; Tofighi, Babak; Laska, Eugene; Goldfeld, Keith; Bonilla, Wanda; Flannery, Mara; Santana-Correa, Nadina; Johnson, Christopher W; Leibowitz, Neil; Rotrosen, John; Gourevitch, Marc N; Lee, Joshua D
PMID: 27743800
ISSN: 1559-2030
CID: 2279732

Hair analysis and its concordance with self-report for drug users presenting in emergency department

Sharma, Gaurav; Oden, Neal; VanVeldhuisen, Paul C; Bogenschutz, Michael P
BACKGROUND: Secondary analysis using data from the National Drug Abuse Treatment Clinical Trials Network randomized trial (NCT # 01207791), in which 1285 adult ED patients endorsing moderate to severe problems related to drug use were recruited from 6 US academic hospitals. OBJECTIVE: To investigate the utility of hair analysis in drug use disorder trials with infrequent visits, and its concordance with Timeline Follow Back (TLFB). METHODS: This study compared the self-reported drug use on the TLFB instrument with the biological measure of drug use from hair analysis for four major drug classes (Cannabis, Cocaine, Prescribed Opioids and Street Opioids). Both hair analysis and TLFB were conducted at 3, 6 and 12 month follow-up visit and each covered a 90-day recall period prior to the visit. RESULTS: The concordance between the hair sample results and the TLFB was high for cannabis and street opioids, but was low to moderate for cocaine and prescribed opioids. Under-reporting of drug use given the positive hair sample was always significantly lower for the drug the study participant noted as their primary drug of choice compared with other drugs the participant reported taking, irrespective of whether the drug of choice was cannabis, cocaine, street opioids and prescribed opioids. Over-reporting of drug use given the negative hair sample was always significantly higher for the drug of choice, except for cocaine. CONCLUSIONS: This study extends the literature on hair analysis supporting its use as a secondary outcome measure in clinical trials.
PMCID:5037031
PMID: 27522871
ISSN: 1879-0046
CID: 2219222

A randomized trial comparing the effect of nicotine versus placebo electronic cigarettes on smoking reduction among young adult smokers

Tseng, Tuo-Yen; Ostroff, Jamie S; Campo, Alena; Gerard, Meghan; Kirchner, Thomas; Rotrosen, John; Shelley, Donna
INTRODUCTION: Electronic cigarette (EC) use is growing dramatically with use highest among young adults and current smokers. One of the most common reasons for using ECs is interest in quitting or reducing cigarettes per day (CPD); however there are few randomized controlled trials (RCT) on the effect of ECs on smoking abstinence and reduction. METHODS: We conducted a two-arm; double-blind RCT. Subjects were randomized to receive 3-weeks of either disposable 4.5% nicotine EC (intervention) or placebo EC. The primary outcome was self-reported reduction of >/=50% in the number of CPDs smoked at week 3 (end of treatment) compared to baseline. Study subjects (n=99) were young adult (21-35), current smokers (smoked >/=10 CPDs) living in NYC. RESULTS: Compared with baseline, a significant reduction in CPDs was observed at both study time periods (1 and 3 weeks) for intervention (p<.001) and placebo (p<.001) groups. Between-group analyses showed significantly fewer CPDs in the intervention group compared to the placebo group at week 3 (p=.03), but not at any other follow-up periods. The logistic regression analysis showed that using a greater number of ECs, treatment condition and higher baseline readiness to quit were significantly associated with achieving >/=50% reduction in CPDs at the end of treatment. CONCLUSION: A diverse young adult sample of current everyday smokers, who were not ready to quit, was able to reduce smoking with the help of ECs. Further study is needed to establish the role of both placebo and nicotine containing ECs in increasing both reduction and subsequent cessation.
PMCID:5016841
PMID: 26783292
ISSN: 1469-994x
CID: 1922122

Awareness and Attitudes Toward Intranasal Naloxone Rescue for Opioid Overdose Prevention

Kirane, Harshal; Ketteringham, Michael; Bereket, Sewit; Dima, Richie; Basta, Ann; Mendoza, Sonia; Hansen, Helena
Opioid overdose prevention is a pressing public health concern and intranasal naloxone rescue kits are a useful tool in preventing fatal overdose. We evaluated the attitudes, knowledge, and experiences of patients and providers related to overdose and naloxone rescue. Over a six month period, patients and providers within a large community hospital in Staten Island were recruited to complete tailored questionnaires for their respective groupings. 100 patients and 101 providers completed questionnaires between August, 2014 and January, 2015. Patient participants were primarily Caucasian males with a mean age of 37.7 years, of which 65% accurately identified naloxone for opioid overdose, but only 21% knew more specific clinical features. 68% of patients had previously witnessed a drug overdose. Notably, 58% of patients anticipated their behavior would change if provided access to an intranasal naloxone rescue kit, of which 83% predicted an increase in opioid use. Prior overdose was significantly correlated with anticipating no change in subsequent opioid use pattern (p=0.02). 99% of patients reported that their rapport with their health-care provider would be enhanced if offered an intranasal naloxone rescue kit. As for providers, 24% had completed naloxone rescue kit training, and 96% were able to properly identify its clinical application. 50% of providers felt naloxone access would decrease the likelihood of an overdose occurring, and 58% felt it would not contribute to high-risk behavior. Among providers, completion of naloxone training was correlated with increased awareness of where to access kits for patients (p<0.001). This study suggests that patients and providers have distinct beliefs and attitudes toward overdose prevention. Patient-Provider discussion of overdose prevention enhances patients' rapport with providers. However, access to an intranasal naloxone rescue kit may make some patients more vulnerable to high-risk behavior. Future research efforts examining provider and patient beliefs and practices are needed to help develop and implement effective hospital-based opioid overdose prevention strategies.
PMID: 27568509
ISSN: 1873-6483
CID: 2231882