HBPL Study of the Impact of the NK1 Antagonist Aprepitant
Condition: Cocaine Dependence; Alcohol Dependence
MeSH terms: Alcoholism; Cocaine-Related Disorders
Intervention: Placebo session 1, Aprepitant session 2; Placebo session 1, Placebo session 2
Intervention description: placebo in session 1, Aprepitant 80 mg in session 2, oral administration.; Placebo, one per session, oral administration
Intervention MeSH terms: Aprepitant; Fosaprepitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Cocaine and alcohol dependence (CAD)

Summary:

      The proposed research will focus on investigating the determinants and consequences of CAD
      via measurement of physiological, behavioral and subjective effects of physiologic and
      psychologic stress cues in CAD volunteers in the laboratory, and through examination of the
      effects of the effects of Aprepitant, an NK1 antagonist, on the above effects. This study
      will examine the effects of the above stress cues on cocaine and alcohol craving under acute
      Aprepitant dosing, and under placebo conditions. The study is a within-subjects crossover
      design using 24 subjects.
    

Eligibility criteria:

        Inclusion Criteria

          1. Male or female and 18 years of age to 60

          2. The subject has used cocaine and alcohol at least once per month for at least the past
             year, and has used cocaine and alcohol within 30 days prior to signing consent.

          3. Live within a commutable distance of the Treatment Research Center (TRC) at the
             Penn/VA Center for Studies of Addiction, University of Pennsylvania. We define this to
             be a distance within the service area of Septa, within an hour drive, or a distance
             that both the patient and Principal Investigator (PI) find acceptable.

          4. Understands and signs the informed consent.

        Exclusion Criteria:

          1. Meets Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria for
             current dependence on any substance other than nicotine, cocaine ,alcohol or marijuana

          2. Subjects who test positive on the urine drug screen for any illicit drugs other than
             cocaine and marijuana during screening will be allowed a single retest. Those
             individuals who test positive for amphetamine during screening, given that they
             provide a copy of a prescription, will only be included if they can safely discontinue
             amphetamine use for the duration of the study. Subjects will need to provide a urine
             free of all illicit drugs other than cocaine and marijuana at study onset to be
             randomized. Subjects who test positive for any drugs other than marijuana prior to a
             study session will be allowed a single retest and a chance to reschedule their
             session. If the subject tests positive for any drug other than marijuana at the
             retest, their participation in the study will be terminated.

          3. Subjects who meet current or lifetime DSM-IV criteria for bipolar affective disorder,
             schizophrenia, or any psychotic disorder

          4. Current severe psychiatric symptoms- (e.g., psychosis, dementia, suicidal or homicidal
             ideation, mania or depression requiring anti-depressant therapy) as diagnosed using
             the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID), the Hamilton
             Anxiety Rating Scale (Ham A), and Hamilton Rating Scale for Depression (HAM-D).

          5. Individuals scoring > 10 on the Hamilton Rating Scale for Depression (HAM-D).

          6. Use of any investigational medication within the past 30 days.

          7. Concomitant treatment with psychotropic medications or prescription opioids.

          8. Concomitant use of any one of the following drugs or classes of drugs:

             Reserpine Verapamil theophylline, trimethoprim, cimetidine, haloperidol,
             benzodiazepines, or antiepileptic drugs (AEDs).

          9. Patients with a known hypersensitivity to aprepitant.

         10. Patients with severe concurrent illnesses such as bronchospastic disease,
             hyperthyroidism, diabetes mellitus.

         11. Patients with known AIDS or other serious illnesses that may require hospitalization
             during the study.

         12. Female subjects who are pregnant or lactating, or female subjects of child-bearing
             potential who are not using acceptable methods of birth control; acceptable methods of
             birth control include:

             Barrier method (diaphragm or condom) with spermicide Intrauterine progesterone
             contraceptive system Levonorgestrel implant Medroxyprogesterone acetate contraceptive
             injection, or Oral contraceptives.

         13. Patients with impaired renal function, as indicated by corrected creatinine clearance
             below 60 ml/min as determined by the modified Cockcroft equation (CDC, 1986).

         14. An unacceptable liver panel or liver function tests (LFTs) that may be indicative of
             hepatic dysfunction.

         15. Clinical laboratory tests (e.g., complete blood count (CBC), blood chemistries,
             urinalysis) outside normal limits, as determined by the study PI.

         16. History of significant heart disease or dysfunction (e.g., an arrhythmia which
             required medication, Wolff Parkinson -White Syndrome, angina pectoris, documented
             history of myocardial infarction, heart failure).

         17. Electrocardiography (EKG) indicative of 1st degree heart block, sinus tachycardia,
             left-axis deviation, non-specific ST or T-wave changes.

         18. History of chest pain associated with cocaine use that prompted a visit to a
             physician.

         19. Any medical or psychological condition that could jeopardize the subject's safe
             participation in the trial as determined by the PI.