Treatment Research in Dual Diagnosis: Substance AbuseSevere Mental Illness N01DA59909

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Treatment Research in Dual Diagnosis Substance
Abuse/Severe Mental Illness N01-DA-5-9909

• NIDA Research Contract Award
• PI Robert R. Conley, MD
• 7/15/05-9/30/14

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Specific Aims

• Relocate NIDA IRP to MPRC
• Provide the clinical/medical infrastructure
  necessary to run clinical protocols
• Provide dual diagnosed psychiatric and substance
  dependent research volunteers
• Provide facilities that accommodate specific
  research observations and support activities

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High Comorbidity

• 29 of those with mental illness have a
  drug/alcohol diagnosis
• Additional 16 have a lifetime Dx of substance
  use
• 55 of those with drug abuse/dependency have a
  serious mental illness
• 37 with alcohol abuse/dependency have a serious
  mental illness

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In 2003, An Estimated 21.6 Million
Americans Were Dependent On or Abused Any Illicit
Drugs or Alcohol ButOnly 3.3 Million -15-
Of These Individuals Had Received Some Type
of Treatment In the Past Year
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What is this award?

• Collaboration between NIH/NIDA intramural program
  and UMAB extramural scientists
• One of five new N-99 awards
• Forward funded for 26M through 2014
• Establishes a branch of NIDA at MPRC/SGHC
• Will support the work of intramural NIH
  scientists
• Approved for 20M in extended support, if new
  science is developed

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NIDA
Office of the Director
Nora D. Volkow, MD
Director
Director, AIDS Research
Special Populations Office
Timothy P. Condon, Ph.D.
Deputy Director
Laura S. Rosenthal
Associate Director for Management
Office of Extramural Affairs
Office of Planning Resource Management
Office of Science Policy Communications
Center for the Clinical Trials Network
Teresa Levitin, PhD
Laura Rosenthal
Timothy Condon, PhD
Betty Tai, PhD
Division of Clinical Neuroscience, Development
Behavioral Treatment
Division of Epidemiology, Services Prevention
Research
Division of Pharmacotherapies Medical
Consequences of Drug Abuse
Division of Basic Neurosciences Behavior
Research
Intramural Research Program
David Shurtleff, PhD
Frank Vocci, PhD
Wilson Compton, MD, MPE
Barry Hoffer, MD, PhD
Joseph Frascella, PhD
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Award Timeline

• 11/03 NIDA awarded N-99
• 2/04 NIDA site visit
• 3/04 Initial meetings with UMAB DHMH
• 4/04 White Tawes move agreement
• 12/04 NIDA RFP published
• 12/04-1/05 DHMH UMAB meetings

• 3/05 Response to RFP
• 5/05 Peer and internal NIH review completed
• 5/05 Response to review
• 6/05 NIDA/UMAB IRB negotiation meeting
• 6/05 Final contract negotiations
• 7/15/05 contract awarded

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The NIDA contract Initial Goals

• Support for current NIDA clinical studies
• New research in the dually diagnosed
• Traditional substance abuse
• Nicotine
• Overweight
• Proof-of-concept clinical trials
• Observational and/or descriptive studies
• Translational basic science work

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Intramural vs Extramural Projects

• Extramural Model
• PI develops new protocol
• Pilot data
• Internal funding
• IRB approval
• PI applies for funding
• Departmental approval
• External review
• IRB approval
• New protocol begins
• Often 12-24 month process

• Intramural Model
• PI develops new protocol
• Science Review
• 4-8 weeks
• Safety Review
• 2-4 weeks
• Branch chief approves support
• IRB approves study
• New protocol begins
• Usually 3-6 month process

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NIDA Staff Scientists

• Carlo Contoreggi, MD
• Evaluation of acute and chronic stress in
  substance abusers and comorbid populations
• David A. Gorelick, M.D., Ph.D.
• studies of cocaine withdrawal, including PET
  imaging of brain mu-opioid receptors,
• studies of marijuana addiction and withdrawal
• enhancing cocaine metabolism
• Stephen J. Heishman, Ph.D.
• Cognitive effects of nicotine and tobacco from
  behavioral and brain imaging perspectives.
• The effects of tobacco withdrawal and nicotine
  administration via nasal spray.
• Cue-reactivity studies with deprived and
  nondeprived smokers and nonsmokers. 
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• Marilyn A. Huestis, Ph.D
• Mechanisms of action of cannabinoid agonists and
  antagonists.
• Effects of in utero drug exposure, and the
  neurobiology
• Pharmacokinetics of MDMA (Ecstasy).
• Eric Moolchan, M.D.

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NIDA Staff Scientists

• Kenzie L. Preston, Ph.D.
• Develop and test drug treatments for polydrug
  abusers
• Develop treatments for heroin abuse.
• Betty Jo Salmeron, M.D.
• fMRI research administering intravenous cocaine,
  nicotine and MPH.
• Elliot Stein, Ph.D.
• Neurophysiology and neuropharmacology of heroin,
  cocaine, nicotine, and cannabis.
• fMRI to the study of human drug abuse.
• George Uhl, M.D., Ph.D.
• Identification of genes that encode primary
  receptors for cocaine and opiates
• Association genome scanning strategies to
  identify gene vulnerabilities
• Yihong Yang, Ph.D.
• Development of functional and structural MRI
  techniques
• Fast spiral BOLD imaging
• Multislice arterial spin labeling perfusion
  imaging

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New Initiatives

• Substance abuse/schizophrenia
• Pharmacology/genetics
• Reward-mediated learning
• Metabolic abnormalities
• Nicotine
• Proof-of-concept studies
• Clinical trials
• Translational human work
• Animal models/basic science initiatives