HBPL Study of the Impact of the NK1 Antagonist Aprepitant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01176591
Recruitment Status : Terminated
First Posted : August 6, 2010
Last Update Posted : April 3, 2014
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Jennifer Plebani, University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
Cocaine Alcohol Dependence Drug: Aprepitant Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Human Behavioral Pharmacology Laboratory (HBPL) Study of the Impact of the NK1 Antagonist Aprepitant (Emend®) on Stress-Induced Cocaine and Alcohol Craving
Study Start Date : September 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Aprepitant

Arm Intervention/treatment
Active Comparator: Physiological Stressor + Aprepitant Drug: Aprepitant
80 mg per session, oral administration.

Active Comparator: Psychological Stressor + Aprepitant Drug: Aprepitant
80 mg per session, oral administration.

Placebo Comparator: Physiological Stressor + Placebo Drug: Placebo
Placebo, one per session, oral administration

Placebo Comparator: Psychological Stressor + Placebo Drug: Placebo
Placebo, one per session, oral administration

Primary Outcome Measures :
  1. The impact acute dosing with aprepitant has on stress-induced craving for alcohol and cocaine in cocaine and alcohol-dependent individuals. [ Time Frame: 2 weeks ]
    These effects will be measured using self reported data.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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 SCID, the Hamilton Anxiety Rating Scale (Ham A), and Hamilton Ration 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 Levonorgesterel 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 (liver function tests; LFTs) that may be indicative of hepatic dysfunction.
  15. Clinical laboratory tests (e.g., 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01176591

United States, Pennsylvania
University of Pennsylvania, Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)

Responsible Party: Jennifer Plebani, Principal Investigator, University of Pennsylvania Identifier: NCT01176591     History of Changes
Other Study ID Numbers: 811184
First Posted: August 6, 2010    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: April 2014

Keywords provided by Jennifer Plebani, University of Pennsylvania:
Cocaine and alcohol dependence (CAD)

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Autonomic Agents
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists