The candidate of this K23 Mentored Patient-Oriented Career Development Award application, John J. Mariani, MD, requests support for a five-year program of training and research aimed at developing expertise in the development, execution, and analysis of pharmacotherapy clinical trials for substance use disorders. Dr. Mariani proposes career development activities that build on his background in psychiatry and clinical research and capitalize on the resources of Columbia University and the New York State Psychiatric Institute to aid him achieving the long-term goal of becoming an independent investigator. As part of a comprehensive educational plan, Dr. Mariani will receive intensive mentoring and didactics in biostatistics, clinical trial study design and logistics, the ethical conduct of research, manuscript preparation, and grant writing and management. The short-term goals are to acquire skills in the design, operation and analysis of a randomized controlled trial. Dr. Mariani will reach these goals by engaging in an integrated educational program of didactics and research. The proposed research plan consists of a randomized double-blind, placebo-controlled trial of gabapentin in the treatment of benzodiazepine-abusing opioid-dependent patients receiving methadone maintenance treatment. It is estimated that approximately one-third of patients in methadone maintenance treatment abuse benzodiazepines and there are no known effective treatments. Gabapentin, an antiseizure medication with a wide safety margin, has shown promise in the treatment of alcohol-related disorders. Since benzodiazepines and alcohol have similar mechanisms of actions, gabapentin is an excellent candidate for study as a potential pharmacotherapy for benzodiazepine use disorders. Conduct of this clinical study will build on Dr. Mariani's prior work in evaluating the use of anticonvulsant agents as pharmacotherapies for substance use disorders. The goal of this K23 Mentored Patient-Oriented Career Development Award is to provide Dr. Mariani with the necessary training and research experience to become an independent investigator. Relevance to Public Health: Benzodiazepine abuse is a common problem in opioid-dependent patients receiving methadone maintenance treatment for which there are no known effective treatment. Development of an effective treatment strategy would have a direct positive impact on public health.

National Institute of Health (NIH)
National Institute on Drug Abuse (NIDA)
Mentored Patient-Oriented Research Career Development Award (K23)
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Study Section
Human Development Research Subcommittee (NIDA)
Program Officer
Bough, Kristopher J
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Columbia University (N.Y.)
Schools of Medicine
New York
United States
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Mariani, John J; Malcolm, Robert J; Mamczur, Agnieszka K et al. (2016) Pilot trial of gabapentin for the treatment of benzodiazepine abuse or dependence in methadone maintenance patients. Am J Drug Alcohol Abuse 42:333-40
Mariani, John J; Pavlicova, Martina; Mamczur, Agnieszka K et al. (2014) Open-label pilot study of quetiapine treatment for cannabis dependence. Am J Drug Alcohol Abuse 40:280-4
Mariani, John J; Pavlicova, Martina; Bisaga, Adam et al. (2012) Extended-release mixed amphetamine salts and topiramate for cocaine dependence: a randomized controlled trial. Biol Psychiatry 72:950-6
Mariani, John J; Cheng, Wendy Y; Bisaga, Adam et al. (2011) Comparison of clinical trial recruitment populations: treatment-seeking characteristics of opioid-, cocaine-, and cannabis-using participants. J Subst Abuse Treat 40:426-30
Mariani, John J; Brooks, Daniel; Haney, Margaret et al. (2011) Quantification and comparison of marijuana smoking practices: blunts, joints, and pipes. Drug Alcohol Depend 113:249-51
Mariani, John J; Haney, Margaret; Hart, Carl L et al. (2009) Effects of research setting on observed depressive symptoms in marijuana users. J Subst Abuse Treat 37:431-4
Mariani, John J; Levin, Frances R (2008) Levetiracetam for the treatment of co-occurring alcohol dependence and anxiety: case series and review. Am J Drug Alcohol Abuse 34:683-91
Mariani, John J; Horey, Jonathan; Bisaga, Adam et al. (2008) Antisocial behavioral syndromes in cocaine and cannabis dependence. Am J Drug Alcohol Abuse 34:405-14
Mariani, John J; Levin, Frances R (2007) Treatment strategies for co-occurring ADHD and substance use disorders. Am J Addict 16 Suppl 1:45-54;quiz 55-6
Mariani, John J; Levin, Frances R (2007) Quetiapine treatment of zolpidem dependence. Am J Addict 16:426