HBPL Study of the Impact of the NK1 Antagonist Aprepitant

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jennifer Plebani, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01176591
First received: August 4, 2010
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Cocaine
Alcohol Dependence
Drug: Aprepitant
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    These effects will be measured using self reported data.


Enrollment: 12
Study Start Date: September 2010
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176591

Locations
United States, Pennsylvania
University of Pennsylvania, Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
  More Information

No publications provided

Responsible Party: Jennifer Plebani, Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01176591     History of Changes
Other Study ID Numbers: 811184
Study First Received: August 4, 2010
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Aprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 22, 2014