Education

Faribault State Hospital, Faribault, MN. Consultant in Behavior Modification, 1969-1971.

Licensed Psychologist: Maryland, 1973-present. Registered, National Register of Health Service Providers in Psychology, 1978-present.

Johns Hopkins University School of Medicine, Baltimore, MD, Department of Psychiatry & Behavioral Sciences, Assistant Professor, 1971-1976; Associate Professor, 1976-1989; Professor, 1990-present. Joint Appointment, JHU Bloomberg School of Public Health: Department of Behavioral Sciences and Health Education, 1986-1987, Department of Health Policy and Management, 1987-present.

Federal Service: Ad hoc Study Section member, intermittently; various USPHS/NIH Institutes, primarily NIDA, concerning substance use/abuse/dependence, smoking, behavioral medicine.

FDA: Drug Abuse Advisory Committee, Member 1987-1993; Consultant, 1993-2002.

Honors: USPHS Research Scientist Development Award and Research Scientist Award: 1977-2003.

Fellow of: College on Problems of Drug Dependence; American Psychological Association; American Psychological Society; Society of Behavioral Medicine.

President of: Division of Psychopharmacology of the American Psychological Association, 1987-1988; College on Problems of Drug Dependence, 1993-94.

Recipient of: Nyswander/Dole (Marie) Award, American Methadone Treatment Assoc, 1997.

Memberships/Service: College on Problems of Drug Dependence (Board of Directors 1989-1998; Treasurer, 1995-1998); American Psychological Association (Division of Psychopharmacology & Substance Abuse, Division of Experimental Analysis of Behavior; Division of Health Psychology); American Psychological Society; Behavioral Pharmacology Society; Association for Advancement of Behavior Therapy; Society of Behavioral Medicine; Research Society on Alcoholism; American Public Health Association.

Institutional Service: IRB for Human Research, 1975-present; General Clinical Research Center Advisory Committee, 1986-present; Advisory Committee on Conflict of Interest, 1996-present.

Strain, E.C., Stitzer, M.L., Liebson, I.A., & Bigelow, G.E. (1993). Dose-response effects of methadone in the treatment of opioid dependence. Annals of Internal Medicine, 119, 23-27.

Walsh, S.L., Preston, K.L., Stitzer, M.L., Cone, E.J., & Bigelow, G.E. (1994). Clinical pharmacology of buprenorphine: Ceiling effects at high doses. Clinical Pharmacology and Therapeutics, 55, 569-580.

Strain, E.C., Stitzer, M.L., Liebson, I.A., & Bigelow, G.E. (1994). Comparison of buprenorphine and methadone in the treatment of opioid dependence. American Journal of Psychiatry, 151, 1025-1030.

Bigelow, G.E., & Preston, K.L. (1995). Opioids. In F.E. Bloom & D.J. Kupfer (Eds.) Psychopharmacology: The Fourth Generation of Progress, (pp 1731-1744) New York: Raven Press.

Johnson, R.E., Eissenberg, T., Stitzer, M.L., Strain, E.C., Liebson, I.A., and Bigelow, G.E. (1995). A placebo controlled clinical trial of buprenorphine as a treatment for opioid dependence. Drug and Alcohol Dependence, 40, 17-25.

Walsh, S.L., Sullivan, J.T., Preston, K.L., Garner, J.E., & Bigelow, G.E. (1996). The effects of naltrexone on response to intravenous cocaine, hydromorphone and their combination in humans. Journal of Pharmacology and Experimental Therapeutics, 279, 524-538.

Brooner, R.K., King, V.L., Kidorf, M., Schmidt, C.W., & Bigelow, G.E. (1997). Psychiatric and substance use comorbidity among treatment-seeking opioid abusers. Archives of General Psychiatry, 54, 71-80.

Eissenberg, T., Bigelow, G.E., Strain, E.C., Walsh, S.L., Brooner, R.K., Stitzer, M.L., & Johnson, R.E. (1997). Dose-related efficacy of levo-alpha acetyl methadol for treatment of opioid dependence: A randomized clinical trial. Journal of the American Medical Association, 277, 1945-1951.

Bigelow, G. E., & Walsh, S.L. (1998). Evaluation of potential pharmacotherapies: response to cocaine challenge in the human laboratory. In S. Higgins & J. Katz (Eds.). Cocaine Abuse Research: Pharmacology, Behavior, and Clinical Applications. (pp. 209-238 ) Academic Press, CA.

Bigelow, G.E., Brooner, R.K., & Silverman, K. (1998). Competing motivations: drug reinforcement vs non-drug reinforcement. Journal of Psychopharmacology, 12, 8-14.

Houtsmuller, E.J., Walsh, S.L., Schuh, K.J., Johnson, R.E., Stitzer, M.L., & Bigelow, G.E. (1998). Dose-response analysis of opioid cross-tolerance and withdrawal suppression during LAAM maintenance. Journal of Pharmacology and Experimental Therapeutics, 285, 387-396.

Strain, E.C., Bigelow, G.E., Liebson, I.A., & Stitzer, M.L. (1999). Moderate- vs high-dose methadone in the treatment of opioid dependence: A randomized trial. Journal of the American Medical Association, 281, 1000-1005.

Walsh, S.L., Haberny, K.A., & Bigelow, G.E. (2000). Modulation of intravenous cocaine effects by chronic oral cocaine in humans. Psychopharmacology, 150, 361-373

Strain, E.C., Stoller, K., Walsh, S.L., & Bigelow, G.E. (2000). The effects of buprenorphine versus buprenorphine/naloxone tablets in non-dependent opioid abusers. Psychopharmacology, 148, 374-383.

Preston, K. L., Bigelow G.E. (2000). Effects of agonist-antagonist opioids in humans trained in a hydromorphone/not hydromorphone discrimination. Journal of Pharmacology and Experimental Therapeutics, 295 (1), 114-124.

Johnson, R.E., Chutuape, M.A., Strain, E.C., Walsh, S.L., Stitzer, M.L., & Bigelow, G.E. (2000). A comparison of levomethadyl acetate, buprenorphine, and methadone for opioid dependence. New England Journal of Medicine, 343, 1290-1297.

Abreu, M.E., Bigelow, G.E., Fleisher, L., & Walsh, S.L. (2001). Effect of intravenous injection speed on responses to cocaine and hydromorphone in humans. Psychopharmacology, 154, 76-84.

Bigelow, G.E. (2001). An operant behavioral perspective on alcohol abuse and dependence. In N. Heather, T.J. Peters & T. Stockwell (Eds.) International Handbook of Alcohol Dependence and Problems (pp. 299-315). Chichester: John Wiley & Sons.

Evans, S.M., Walsh, S.L., Levin, F.R., Foltin, R.W., Fischman, M.W., & Bigelow, G.E. (2001). Effects of flupenthixol on subjective and cardiovascular responses to intravenous cocaine in humans. Drug and Alcohol Dependence, 64, 271-283.

Nann-Vernotica, E., Donny, E.C., Bigelow, G.E., & Walsh, S.L. (2001). Repeated administration of the D_1/5 antagonist ecopipam fails to attenuate the subjective effects of cocaine. Psychopharmacology, 155, 338-347.

Stoller, K.B., Bigelow, G.E., Walsh, S.L., & Strain, E.C. (2001). Effects of buprenorphine/naloxone in opioid-dependent humans. Psychopharmacology, 154, 230-242.

Donny, E.C., Walsh, S.L., Bigelow, G.E., Eissenberg, T., & Stitzer, M.L. (2002). High-dose methadone produces superior opioid blockade and comparable withdrawal suppression to lower doses in opioid-dependent humans. Psychopharmacology, 161, 202-212.

Strain, E.C., Walsh, S.L., & Bigelow, G.E. (2002). Blockade of hydromorphone effects by buprenorphine/naloxone and buprenorphine. Psychopharmacology, 159, 161-166.

Donny, E.C., Bigelow, G.E., Walsh, S.L. (2003). Choosing to take cocaine in the human laboratory: effects of cocaine dose, inter-choice interval, and magnitude of alternative reinforcement. Drug and Alcohol Dependence, 69, 289-301.

Zacny, J. Bigelow, G., Compton, P., Foley, K., Iguchi, M., & Sannerud, C. (2003). College on Problems of Drug Dependence taskforce on prescription opioid non-medical use and abuse: position statement. Drug and Alcohol Dependence, 69, 215-232.

Walsh, S.L., Strain, E.C., Bigelow, G.E. (2003). Evaluation of the effects of lofexidine and clonidine on naloxone-precipitated withdrawal in opioid-dependent humans. Addiction, , 98, 427-439.

Bigelow, G.E., Rand, C.S. (2003 ). Tobacco use and dependence. In LR Barker, JR Burton, PD Zieve (Eds.) Principles of Ambulatory Medicine, Sixth Edition, Lippincott Williams & Wilkins, Philadelphia, PA, pp 321-333.

Balster RL, Bigelow GE. (2003). Guidelines and methodological reviews concerning drug abuse liability assessment. Drug and Alcohol Dependence, 70 (3) Supplement 1, S13-S40.

Griffiths RR, Bigelow GE, Ator NA. (2003). Principles of initial experimental drug abuse liability assessment in humans. Drug and Alcohol Dependence, 70 (3) Supplement 1 ,.S41-S54.

Research Support, Projects, and Role. Selected ongoing or completed (in past 3 years) research projects.

Dr. Bigelow serves as the Director of the Behavioral Pharmacology Research Unit (BPRU), a multi-faceted clinical research program specializing in studies of substance abuse and its treatment. He has overall responsibility for planning, oversight and supervision of the major elements of BPRU’s research resources -- a recruitment and assessment screening program for enrolling volunteers with appropriate substance use/abuse histories; operation of a 14-bed residential research facility; operation of a 150-slot outpatient substance abuse treatment research clinic; traininng and supervision of research fellows and research staff in conduct of substance abuse-related clinical research. Recent funded projects are listed and described below. In addition to the above-mentioned resource-management responsibilities Dr. Bigelow’s role includes participation in:

1981-2006; NIDA T32-DA07209 Post-doc training grant (Program Director)

"Human Behavioral Phamacology of Substance Abuse"

This institutional research training grant supports 10 postdoctoral fellows in supervised research and training on human substance abuse and its treatment.

1988-2003; NIDA P50-DA05273 Center grant (Principal Investigator)

"Treatment Research Center: Behavioral Pharmacology"

Includes components focusing on: Assessment of psychiatric and poly-substance co-morbidities in substance abuse patients; Double-blind outpatient controlled clinical trials comparing the opioid-dependence pharmacotherapies methadone, LAAM, and buprenorphine; Human laboratory studies of factors modulating heroin reinforcement; Evaluation of behavioral incentive interventions for promoting psychosocial treatment participation in outpatients.

1987-2002; NIDA R01-DA05196 (Principal Investigator)

"Pharmacological Modulation of Cocaine Effects"

Human laboratory studies of the effects of potential anti-cocaine pharmacotherapies on cocaine effects, cocaine craving, and cocaine choice behavior. Studies have evaluated a range of direct and indirect dopamine agonists and antagonists and serotonergic agents.

2001-2003; Alkermes, Inc. contract (Principal Investigator)

"Evaluation of Medisorb Naltrexone"

Evaluation of the pharmacokinetics and extent and duration of opioid blockade of an extended-release injectable depot formulation of naltrexone under developmentt for treatment of alcoholism and/or opioid abuse.

1999-2004; NIDA U10-DA13034 (Co-Investigator)

"Clinical Trials Network: Mid-Atlantic Node" (P.I. = M.L. Stitzer)

A national-network cooperative agreement for conducting clinical trials of research-based substance abuse treatments in community treatment programs, and for studying the process of innovative treatment adoption by providers.

1993-2006; NIDA NIDA R01 DA 08045 (Co-Investigator)

"Evaluation of Opioid Antagonist Activity in Humans" (P.I. = E.C. Strain)

This project conducts human laboratory studies of opioid agonist and antagonist effects, with an emphasis on the characterization, abuse liability, and efficacy of buprenorphine and buprenorphine/naloxone in different subject groups.

2000-2005; NIAAA R01-AA12154 (Co-Investigator)

"A Therapeutic Workplace for Homeless Alcoholics" (P.I. = K. Silverman)

A randomized outpatient clinical trial evaluating an incentive-based behavioral treatment for alcoholism. Following inpatient detoxification volunteers receive either usual care or voucher-based abstinence reinforcement via an innovative job-skills training program.

1996-2006; NIDA R01 DA 10754 (Co-Investigator)

"Serotonin Treatment of Cocaine Dependence" (P.I. = E.C. Strain)

This project evaluates the serotonergic medications such as fluoxetine in the outpatient treatment of cocaine dependence.

1999-2004; NIDA R01 DA 12439 (Co-Investigator)

"Parametric Studies of Drug Abuse Abstinence Incentives" (P.I. = M.L. Stitzer)

This grant uses brief abstinence incentive procedures both as a clinical tool to promote initial abstinence from cocaine and other drugs in methadone maintenance patients and as a research tool to study parameters of monetary-based incentive therapies.

1996-2003; NIDA R01 DA 10753 (Co-Investigator)

"Therapeutic Potential of Kappa-Opioids Against Cocaine" (P.I. = S.L. Walsh)

This project evaluates the acute effects and safety of opioid kappa agonist compounds when given alone and in combination with cocaine to humans to assess their ability to alter the direct effects of cocaine and cocaine self-administration.

1999-2001; Drug Abuse Sciences, Inc. contract (Principal Investigator)

"Evaluation of Depot Naltrexone"

Evaluation of the pharmacokinetics and opioid blockade activity of an extended-release injectable depot formulation of naltrexone under development for treatment of alcoholism and/or opioid abuse.

1999-2001; Purdue Pharma, LLP contract (Principal Investigator)

"Abuse Liability Assessment of Transdermal versus Injected Buprenorphine"

A human laboratory evaluation comparing the abuse liability profiles (subjective, physiological, and behavioral effects) of two different formulations of the opioid analgesic and partial agonist buprenorphine.

1999-2001; Abell Foundation & NIDA P50-DA05273 (Principal Investigator)

"Comparison of Heroin and Hydromorphone"

A human laboratory clinical pharmacology comparison of these drugs across a range of doses and comparing i.v. and s.c. routes of administration. Relevant to the pharmacological equivalence of hydromorphone to heroin in laboratory studies and in potential injection-therapy treatments for heroin dependence.

E-mail contact: bigelow@jhmi.edu