Abstract

This investigation is part of a multi-center study that will assess the safety of administering moderate and high doses of acamprosate and naltrexone both as single agents and in combination to non-treatment seeking alcohol dependant/abusing subjects. This study will also examine how single dose alcohol challenge influences the clinical tolerance of the drug doses and combinations that are to be tested. Finally, the pharmacokinetic interactions between acamprosate and naltrexone will be studied. Both behavioral and organ system toxicity will be evaluated in this study. Test agents will be administered to four groups of subjects in four phases following a mixed model random-block design. Placebo will be administered in Phase I, single agents in Phase II, while the final two phases will involve dose escalation of drug combinations. The data collected from this investigation will identify combinations of naltrexone and acamprosate that can be safely administered in a planned multi-center efficacy trial.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000533-32
Application #
6409697
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1978-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
32
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
Boston University
Department
Type
DUNS #
604483045
City
Boston
State
MA
Country
United States
Zip Code
02118

  Publications

Rhee, Rennie L; Davis, John C; Ding, Linna et al. (2018) The Utility of Urinalysis in Determining the Risk of Renal Relapse in ANCA-Associated Vasculitis. Clin J Am Soc Nephrol 13:251-257
Liebschutz, Jane M; Buchanan-Howland, Kathryn; Chen, Clara A et al. (2018) Childhood Trauma Questionnaire (CTQ) correlations with prospective violence assessment in a longitudinal cohort. Psychol Assess 30:841-845
Guan, Yue; Roter, Debra L; Wolff, Jennifer L et al. (2018) The impact of genetic counselors' use of facilitative strategies on cognitive and emotional processing of genetic risk disclosure for Alzheimer's disease. Patient Educ Couns 101:817-823
Altman, Matthew C; Whalen, Elizabeth; Togias, Alkis et al. (2018) Allergen-induced activation of natural killer cells represents an early-life immune response in the development of allergic asthma. J Allergy Clin Immunol 142:1856-1866
Berti, Alvise; Warner, Roscoe; Johnson, Kent et al. (2018) Brief Report: Circulating Cytokine Profiles and Antineutrophil Cytoplasmic Antibody Specificity in Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. Arthritis Rheumatol 70:1114-1121
Christensen, Kurt D; Uhlmann, Wendy R; Roberts, J Scott et al. (2018) A randomized controlled trial of disclosing genetic risk information for Alzheimer disease via telephone. Genet Med 20:132-141
Kattan, Meyer; Bacharier, Leonard B; O'Connor, George T et al. (2018) Spirometry and Impulse Oscillometry in Preschool Children: Acceptability and Relationship to Maternal Smoking in Pregnancy. J Allergy Clin Immunol Pract 6:1596-1603.e6
Wallace, Zachary S; Miloslavsky, Eli M; Cascino, Matthew et al. (2017) Effect of Disease Activity, Glucocorticoid Exposure, and Rituximab on Body Composition During Induction Treatment of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. Arthritis Care Res (Hoboken) 69:1004-1010
Gern, James E; Calatroni, Agustin; Jaffee, Katy F et al. (2017) Patterns of immune development in urban preschoolers with recurrent wheeze and/or atopy. J Allergy Clin Immunol 140:836-844.e7
Guan, Yue; Roter, Debra L; Erby, Lori H et al. (2017) Disclosing genetic risk of Alzheimer's disease to cognitively impaired patients and visit companions: Findings from the REVEAL Study. Patient Educ Couns 100:927-935

Showing the most recent 10 out of 476 publications