Bupropion, a "second generation" antidepressant with no reported abuse liability, has been reported to be effective in combination with psychotherapy in substantially reducing cocaine use in cocaine-dependent patients. Bromocriptine, a dopamine receptor type 2 (D2) agonist, has demonstrated good results in treating both withdrawal symptoms and long-term craving due to cocaine abuse. This is an open-label study with combination of bupropion and bromocriptine for treatment of cocaine-dependent patients. This combination is expected to have a summation of pharmacological actions on brain dopamine systems, with the possibility of using lower doses of each medication to minimize the risk of side-effects. Twenty five (25) subjects will be entered into the study. All subjects will undergo medical, psychological, and laboratory evaluation. Subjects will report to the ARC 3 days each week for 8 weeks. All subjects will receive individual counseling at one of their weekly visits. The primary outcome measure will be cocaine and other drug use as determined by assay of urine samples collected under direct staff observation. Secondary outcome measures will include: 1) retention time in the study (8 weeks), 2) number of missed clinic visits, 3) subject reported side-effects, 4) results from blood chemistries and urinalysis, 5) cocaine craving scales, 6) cocaine 100 mm visual-analog scales, 7) subject self-reported drug use, 8) SCL-90R, and 9) changes in psychosocial functioning as measured by the Addiction Severity Index. Every 2 weeks blood will be drawn to measure medication blood levels to verify medication compliance, assess therapeutic blood levels, prolactin levels, and assess CBC and liver function. Two subjects have been consented to participate in this study.
NIH ExPorter
NIH ExPorter