Collaboration with the private sector is an important part of BPRU’s overall scientific contribution. We view these partnerships as opportunities to lend our scientific knowledge and clinical experience to improving the drug development process and to enhancing public access to more safe and effective medications. BPRU offers expertise and resources for a broad range of clinical research related to assessing the behavioral effects of drugs. Clinical research areas include:
- Clinical Trials of Substance Abuse Treatments (for drugs, alcohol, & tobacco)
- Drug Abuse Liability Testing
- Drug Effects on Cognitive Function and Performance
Facilities are available for outpatient clinical trials and residential or ambulatory human laboratory studies.
Pharmacotherapies for Substance Abuse
A special focus at BPRU has been in the development of new medications that may be useful in the treatment of drug abuse. BPRU was instrumental in the development of buprenorphine for the treatment of opioid dependence. Buprenorphine is now a primary medication used for opioid dependence treatment in the U.S. We have also worked with industry partners to develop smoking cessation and alcohol treatment medications and are active in searching for and developing treatments for cocaine dependence.
Strain, E.C., Harrison, J.A., Bigelow, G.E. (2011). Induction of opioid-dependent individuals onto buprenorphine and buprenorphine/naloxone soluble films. Clinical Pharmacology & Therapeutics, 89(3), 443 – 449.
Ling, W., Cassadonte, P., Bigelow, G., Campman, K.M., Patkar, A., Bailey, G.L., Rosenthal, R.N., Beebe, K.L. (2010). Buprenorphine implants for treatment of opioid dependence: a randomized controlled trial. Journal of the American Medical Association, 304(14), 1576 - 83.
Abuse Liability Assessment
The non-medical use of prescription drugs is a major concern in the U.S. Assessing the abuse liability of a drug candidate has become a critical step in the development process. In addition, scheduling of a drug under the Controlled Substances Act (CSA) is dependent upon the evaluation of the substance’s abuse liability. BPRU has extensive experience in abuse liability testing, and cognitive and performance testing assessment of compounds including opioids, benzodiazepines, stimulants and other novel drug substances. BPRU faculty have published extensively both on the general principles of abuse liability assessment and on the abuse potential of specific substances. Based on this experience we are able recommend effective and efficient strategies for assessment of a compound’s abuse liability in support of a New Drug Application and appropriate scheduling under the CSA.
Carter, L.P., Griffiths, R.R. (2009). Principles of laboratory assessment of drug abuse liability and implications for clinical development. Drug and Alcohol Dependence, 105S, S14 – S25.
Johnson, M.W., Suess, P.E., Griffiths, R.R. (2006). Ramelteon: a novel hypnotic lacking abuse liability and sedative adverse effects. Archives of General Psychiatry, 63, 1149 – 1157.
Griffiths, R.R., Bigelow, G.E., Ator, N.A. (2003). Principles of initial experimental drug abuse liability assessment in humans. Drug and Alcohol Dependence, 20, S41 – S54.
Cognitive Function and Performance Assessment
Our state-of-the-art techniques allow for the assessment of a wide range of functions and processes including oculomotor function, sensory perception, psychomotor coordination, reaction time, tracking, attention, working memory, episodic memory, inhibitory control, impulsivity, risk taking, decision making, and executive functions. In previous studies, we have been able to detect subtle differences in the effects of different classes of drugs on specific cognitive processes and to characterize the unique patterns of impairment in a variety of clinical populations. BPRU’s cognitive testing capability can be applied to a range of projects and settings including abuse liability trials, comparative clinical pharmacology studies, clinical trials of pharmacological or non-pharmacological treatments, and cognitive enhancer trials, and can also be combined with polysomnographic and neuroimaging methodologies to understand underlying brain mechanisms.
Mintzer, M.Z., Kleykamp, B.A., Griffiths, R.R. (2010). Dose effects of triazolam and scopolamine on metamemory. Experimental and Clinical Psychopharmacology, 18(1), 17 – 31.
Mintzer, M.Z., Lanier, R.K., Lofwall, M.R., Bigelow, G.E., Strain, E.C. (2010). Effects of repeated tramadol and morphine administration on psychomotor and cognitive performance in opioid-dependent volunteers. Drug and Alcohol Dependence, 111(3), 265 – 268.
Inquiries can be directed to Joe Harrison, BPRU Senior Program Manager, at 410-550-3073 or at email@example.com.