This Center for Medications Development (MDU) has a theme of cocaine pharrnacotherapy with eight outpatient randomized clinical trials in four comorbid populations: depressed, opioid dependent (methadone and LAAM), and those with brain perfusion defects. These eight trials are arranged sequentially with four during months 1 to 30 (trials #1,3,5,7) and four during months 31-60 (trials #2,4,6,8). Trials 1 and 2 are """"""""Bupropion & sertraline for depression and cocaine dependence"""""""" including 60 patients each in randomized, placebo controlled 12 week trials - bupropion (#1) and sertraline (#2). Trials 3 and 4 are """"""""Disulfiram & GABA agonists with LAAM for cocaine"""""""" including 60 patients in randomized, placebo controlled 12 week trials of first disulfiram (#3) and then one of the GABA agents tiagabine or baclofen (#4). Trial 5 in methadone patients will involve tiagabine and baclofen in an 8 week screening study that allocates 60 subjects to five cells including placebo and two doses of each agent during the first 30 months. Trial 6 uses a similar screening design involving glutamate antagonists - acamprosate and lamotrigine in months 31-60. Trials 7 and 8 are """"""""Clopidogrel & isradipine for brain perfusion defects"""""""" involving blood flow neuroimaging in two different groups of 60 patients with these cocaine-induced defects as an outcome. These 12 week trials of first clopidogrel (#7) and then isradipine (#8) include 4 weeks residential with an 8 week outpatient follow-up. Overall, about 500 patients will be studied in this Center and nine different agents in either screening (trials 5 & 6) or full Phase ll trials.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Specialized Center (P50)
Project #
5P50DA012762-05
Application #
6658201
Study Section
Special Emphasis Panel (ZDA1-KXA-N (27))
Program Officer
Biswas, Jamie
Project Start
1999-09-30
Project End
2005-02-28
Budget Start
2003-09-01
Budget End
2005-02-28
Support Year
5
Fiscal Year
2003
Total Cost
$946,778
Indirect Cost
Name
Yale University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520
Bashiri, Maryam; Mancino, Michael J; Stanick, Virginia A et al. (2017) Moderators of response to sertraline versus placebo among recently abstinent, cocaine dependent patients: A retrospective analysis of two clinical trials. Am J Addict 26:807-814
DeVito, Elise E; Herman, Aryeh I; Konkus, Noah S et al. (2017) Atomoxetine in abstinent cocaine users: Cognitive, subjective and cardiovascular effects. Pharmacol Biochem Behav 159:55-61
Mancino, Michael J; McGaugh, Janette; Chopra, Mohit P et al. (2014) Clinical efficacy of sertraline alone and augmented with gabapentin in recently abstinent cocaine-dependent patients with depressive symptoms. J Clin Psychopharmacol 34:234-9
Orson, Frank M; Rossen, Roger D; Shen, Xiaoyun et al. (2013) Spontaneous development of IgM anti-cocaine antibodies in habitual cocaine users: effect on IgG antibody responses to a cocaine cholera toxin B conjugate vaccine. Am J Addict 22:169-74
Oliveto, Alison; Poling, James; Mancino, Michael J et al. (2012) Sertraline delays relapse in recently abstinent cocaine-dependent patients with depressive symptoms. Addiction 107:131-41
Sofuoglu, Mehmet; Mooney, Marc; Kosten, Thomas et al. (2011) Minocycline attenuates subjective rewarding effects of dextroamphetamine in humans. Psychopharmacology (Berl) 213:61-8
Mancino, Michael J; Gentry, Brooks W; Feldman, Zachary et al. (2011) Characterizing methamphetamine withdrawal in recently abstinent methamphetamine users: a pilot field study. Am J Drug Alcohol Abuse 37:131-6
Kinsey, Berma M; Kosten, Thomas R; Orson, Frank M (2010) Active immunotherapy for the Treatment of Cocaine Dependence. Drugs Future 35:301-306
Martell, Bridget A; Orson, Frank M; Poling, James et al. (2009) Cocaine vaccine for the treatment of cocaine dependence in methadone-maintained patients: a randomized, double-blind, placebo-controlled efficacy trial. Arch Gen Psychiatry 66:1116-23
Sofuoglu, Mehmet; Poling, James; Hill, Kevin et al. (2009) Atomoxetine attenuates dextroamphetamine effects in humans. Am J Drug Alcohol Abuse 35:412-6

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