Abstract

This proposal is in response to RFA-DA-04-014, """"""""Medications Development for Cannabis-Related Disorder."""""""" The Food and Drug Administration (FDA) recently (January 3, 2003) approved fluoxetine for the treatment of major depression among adolescents and children, based on the results of two acute phase double-blind, placebo-controlled studies (Emslie et al., 1997;2002). Fluoxetine thus became the first antidepressant medication to receive FDA approval for treatment of major depressive disorder (MDD) among adolescents and children. It is unclear to what extent those results apply to adolescents with comorbid MDD and a substance use disorder (SUD) such as cannabis abuse or dependence, since adolescents with SUDs were excluded from participation in that study. However, our own preliminary work suggests that fluoxetine is safe and effective for treating the depression, the cannabis related disorder, and the drinking of comorbid adolescents and young adults (Cornelius et al, 1999;2001;2004). In this study, a first large scale prospective double-blind, placebo-controlled study will be conducted to assess the efficacy of the SSRI medication fluoxetine vs. placebo in the treatment of adolescents with comorbid major depressive disorder and a cannabis related disorder (MDD/CRD). All subjects in both treatment groups will also receive Treatment As Usual (TAU) during the acute phase trial, which will consist of motivation enhancement therapy (MET) and Cognitive Behavioral Therapy (CBT). The goals of this study are: 1) to compare the acute phase (12 week) efficacy of the SSRI medication fluoxetine plus TAU vs. placebo plus TAU for the treatment of the cannabis use and the depressive symptoms of an adolescent and young adult (ages 12-25) sample of subjects with comorbid diagnoses of a CRD (cannabis dependence or cannabis abuse) plus MDD;2) to assess specific predictors of medication response;3) to perform a preliminary evaluation of the longer-term efficacy of fluoxetine in this comorbid population.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA019142-05
Application #
7440279
Study Section
Special Emphasis Panel (ZDA1-KXA-N (14))
Program Officer
Montoya, Ivan
Project Start
2004-09-29
Project End
2012-12-31
Budget Start
2009-07-01
Budget End
2012-12-31
Support Year
5
Fiscal Year
2009
Total Cost
$424,905
Indirect Cost

  Institution

Name
University of Pittsburgh
Department
Psychiatry
Type
Schools of Medicine
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213

  Publications

Cornelius, J R; Chung, T A; Douaihy, A B et al. (2016) A Review of the Literature of Mirtazapine in Co-Occurring Depression and an Alcohol Use Disorder. J Addict Behav Ther Rehabil 5:
Cornelius, Jack R; Chung, Tammy; Douaihy, Antoine B et al. (2016) Mirtazapine in comorbid major depression and an alcohol use disorder: A double-blind placebo-controlled pilot trial. Psychiatry Res 242:326-330
Cornelius, Jack R; Kirisci, Levent; Reynolds, Maureen et al. (2015) Does the Transmissible Liability Index (TLI) assessed in late childhood predict suicidal symptoms at young adulthood? Am J Drug Alcohol Abuse 41:264-8
Cornelius, Jack; Kirisci, Levent; Reynolds, Maureen et al. (2014) Does stress mediate the development of substance use disorders among youth transitioning to young adulthood? Am J Drug Alcohol Abuse 40:225-9
Cornelius, Jack R; Haas, Gretchen L; Goldstein, Gerald et al. (2014) The ""S"" Allele of the Serotonin Transporter Is Not Associated with Major Depression in a Sample OF Veterans. Adv Genet Res 12:1-10
Cornelius, Jack R; Haas, Gretchen L; Goldstein, Gerald et al. (2014) The ""S"" Allele of the Serotonin Transporter Is Not Associated with Major Depression or Alcohol Use Disorders in a Veteran Sample. Int J Med Biol Front 20:103-111
Cornelius, Jack R; Aizenstein, Howard J; Chung, Tammy A et al. (2013) Paradoxical Decrease in Striatal Activation on an fMRI Reward Task Following Treatment in Youth with Co-morbid Cannabis Dependence/Major Depression. Adv Psychol Res 93:123-130
Cornelius, Jack R; Kirisci, Levent (2013) Assessing TLI as a Predictor of Treatment Seeking for SUD among Youth Transitioning to Young Adulthood. Adv Psychol Res 98:85-94
Cornelius, Jack R; Douaihy, Antoine B; Kirisci, Levent et al. (2013) LONGER-TERM EFFECTIVENESS OF CBT IN TREATMENT OF COMORBID AUD/MDD ADOLESCENTS. Int J Med Biol Front 19:
Cornelius, Jack R (2013) Editorial Regarding the New DSM-5 Diagnosis of PTSD in Veterans and Non-veterans. J Depress Anxiety 2:139-141

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