- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01176591
HBPL Study of the Impact of the NK1 Antagonist Aprepitant
Human Behavioral Pharmacology Laboratory (HBPL) Study of the Impact of the NK1 Antagonist Aprepitant (Emend®) on Stress-Induced Cocaine and Alcohol Craving
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania, Treatment Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Male or female and 18 years of age to 60
- 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.
- 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.
- Understands and signs the informed consent.
Exclusion Criteria:
- Meets Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria for current dependence on any substance other than nicotine, cocaine ,alcohol or marijuana
- 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.
- Subjects who meet current or lifetime DSM-IV criteria for bipolar affective disorder, schizophrenia, or any psychotic disorder
- 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).
- Individuals scoring > 10 on the Hamilton Rating Scale for Depression (HAM-D).
- Use of any investigational medication within the past 30 days.
- Concomitant treatment with psychotropic medications or prescription opioids.
Concomitant use of any one of the following drugs or classes of drugs:
Reserpine Verapamil theophylline, trimethoprim, cimetidine, haloperidol, benzodiazepines, or antiepileptic drugs (AEDs).
- Patients with a known hypersensitivity to aprepitant.
- Patients with severe concurrent illnesses such as bronchospastic disease, hyperthyroidism, diabetes mellitus.
- Patients with known AIDS or other serious illnesses that may require hospitalization during the study.
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.
- Patients with impaired renal function, as indicated by corrected creatinine clearance below 60 ml/min as determined by the modified Cockcroft equation (CDC, 1986).
- An unacceptable liver panel or liver function tests (LFTs) that may be indicative of hepatic dysfunction.
- Clinical laboratory tests (e.g., complete blood count (CBC), blood chemistries, urinalysis) outside normal limits, as determined by the study PI.
- 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).
- Electrocardiography (EKG) indicative of 1st degree heart block, sinus tachycardia, left-axis deviation, non-specific ST or T-wave changes.
- History of chest pain associated with cocaine use that prompted a visit to a physician.
- Any medical or psychological condition that could jeopardize the subject's safe participation in the trial as determined by the PI.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Placebo Session 1, Aprepitant Session 2
Participants receive placebo in session 1 and Aprepitant in session 2 of a psychological stressor presentation and receive placebo in session 1 and Aprepitant in session 2 of a physiological stressor presentation.
Participants take Aprepitant (80 mg) or placebo tablets for 7 days prior to each session.
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placebo in session 1, Aprepitant 80 mg in session 2, oral administration.
Other Names:
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Placebo Comparator: Placebo Session 1, Placebo Session 2
Participants receive placebo in session 1 and placebo in session 2 of a psychological stressor presentation and receive placebo in session 1 and placebo in session 2 of a physiological stressor presentation.
Participants take placebo tablets for 7 days prior to each session.
The placebo group is used for analysis purposes in order to control for any order effects found in the Experimental group.
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Placebo, one per session, oral administration
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cocaine Craving as Measured on the Visual Analog Scale (VAS) 1
Time Frame: Session 1
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The VAS is a 100 mm line anchored at both ends.
Participants mark where on the line their craving falls, with closer to 0 indicating less craving, and closer to 100 indicating more craving.
Data are analyzed by using a ruler to determine the actual mm value of the participant mark.
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Session 1
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Alcohol Craving as Measured by the Visual Analog Scale (VAS) 1
Time Frame: Session 1
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The VAS is a 100 mm line anchored at both ends.
Participants mark where on the line their craving falls, with closer to 0 indicating less craving, and closer to 100 indicating more craving.
Data are analyzed by using a ruler to determine the actual mm value of the participant mark.
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Session 1
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Cocaine Craving as Measured on the Visual Analog Scale (VAS) 2
Time Frame: Session 2
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The VAS is a 100 mm line anchored at both ends.
Participants mark where on the line their craving falls, with closer to 0 indicating less craving, and closer to 100 indicating more craving.
Data are analyzed by using a ruler to determine the actual mm value of the participant mark.
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Session 2
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Alcohol Craving as Measured by the Visual Analog Scale (VAS) 2
Time Frame: Session 2
|
The VAS is a 100 mm line anchored at both ends.
Participants mark where on the line their craving falls, with closer to 0 indicating less craving, and closer to 100 indicating more craving.
Data are analyzed by using a ruler to determine the actual mm value of the participant mark.
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Session 2
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Multiple Choice Procedure (MCP) 1
Time Frame: Session 1
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The MCP measures the relative reinforcing value of a hypothetical single dose of cocaine, as compared to various monetary values.
The lower the monetary value where participants switch from preferring cocaine to preferring money, the less value they place on cocaine.
MCP findings of cocaine devaluation typically correlate with cocaine abstinence in clinical trials.
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Session 1
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Multiple Choice Procedure (MCP) 2
Time Frame: Session 2
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The MCP measures the relative reinforcing value of a hypothetical single dose of cocaine, as compared to various monetary values.
The lower the monetary value where participants switch from preferring cocaine to preferring money, the less value they place on cocaine.
MCP findings of cocaine devaluation typically correlate with cocaine abstinence in clinical trials.
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Session 2
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Kyle M Kampman, MD, Perelman School of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Alcohol-Related Disorders
- Substance-Related Disorders
- Alcoholism
- Cocaine-Related Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Neurokinin-1 Receptor Antagonists
- Aprepitant
- Fosaprepitant
Other Study ID Numbers
- 811184
- K01DA025073 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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