1. Placebo-controlled evaluation of a bioengineered, cocaine-metabolizing fusion protein, TV-1380 (AlbuBChE), in the treatment of cocaine dependence.

    Drug and Alcohol Dependence 166:13 (2016) PMID 27394932

    TV-1380 (AlbuChE) is a novel recombinant fusion protein of mutated butyrylcholinesterase (BChE) that has increased catalytic efficiency for cocaine metabolism compared to wild-type BChE. Intra-muscular injections of TV-1380 (150mg or 300mg) or placebo were administered once weekly to participant...
  2. Mitigating the Effects of Nonadherence in Clinical Trials.

    The Journal of clinical pharmacology and new drugs 56(9):1151 (2016) PMID 26634893

    Accounting for subject nonadherence and eliminating inappropriate subjects in clinical trials are critical elements of a successful study. Nonadherence can increase variance, lower study power, and reduce the magnitude of treatment effects. Inappropriate subjects (including those who do not have...
  3. Measures of outcome for stimulant trials: ACTTION recommendations and research agenda.

    Drug and Alcohol Dependence 158:1 (2016) PMID 26652899 PMCID PMC4698050

    The development and approval of an efficacious pharmacotherapy for stimulant use disorders has been limited by the lack of a meaningful indicator of treatment success, other than sustained abstinence. In March, 2015, a meeting sponsored by Analgesic, Anesthetic, and Addiction Clinical Trial Tran...
  4. Medication Nonadherence, "Professional Subjects," and Apparent Placebo Responders: Overlapping Challenges for Medications Development.

    Journal of Clinical Psychopharmacology 35(5):566 (2015) PMID 26244381 PMCID PMC4553101

    Nonadherence is a major problem in clinical trials of new medications. To evaluate the extent of nonadherence, this study evaluated pharmacokinetic sampling from 1765 subjects receiving active therapy across 8 psychiatric trials conducted between 2001 and 2011. With nonadherence defined as great...
  5. Deception by Research Participants.

    New England Journal of Medicine 373(13):1192 (2015) PMID 26398069

    Study participants who fabricate, falsify, or fail to disclose important information can undermine the integrity of clinical trials, with negative consequences for both future patients and the participants themselves. What can investigators do to address the problem?
  6. Trends in opioid analgesic abuse and mortality in the United States.

    New England Journal of Medicine 372(16):1572 (2015) PMID 25875269

  7. A novel, nonbinary evaluation of success and failure reveals bupropion efficacy versus methamphetamine dependence: reanalysis of a multisite trial.

    CNS Neuroscience & Therapeutics 18(5):414 (2012) PMID 22070720

    A multisite, double-blind, placebo-controlled trial of bupropion for methamphetamine dependence was reanalyzed using a novel, nonbinary method of evaluating success and failure. The original analysis focused on a group response endpoint (the change in percentage of participants with methamphetam...
  8. Comparison of the effects of methamphetamine, bupropion, and methylphenidate on the self-administration of methamphetamine by rhesus monkeys.

    Experimental and Clinical Psychopharmacology 19(1):1 (2011) PMID 21341918 PMCID PMC3392967

    The effectiveness of methadone as a treatment for opioid abuse and nicotine preparations as treatments for tobacco smoking has led to an interest in developing a similar strategy for treating psychostimulant abuse. The current study investigated the effects of three such potential therapies on i...
  9. Drugs of abuse: management of intoxication and antidotes.

    EXS 100:519 (2010) PMID 20358694

    Illicit drug intoxications are an increasing public health problem for which, in most cases, no antidotes are clinically available. The diagnosis and treatment of these intoxications requires a trained clinician with experience in recognizing the specific signs and symptoms of intoxications to i...
  10. Summary of NIDA medications workshop: new opportunities for chemists and pharmacologists.

    Drug and Alcohol Dependence 92(1-3):307 (2008) PMID 18286704

  11. Rash and fever.

    The Journal of Emergency Medicine 31(3):293 (2006) PMID 16982364

  12. Sixth cranial nerve palsy.

    The Journal of Emergency Medicine 29(2):207 (2005) PMID 16029834