Status:
COMPLETED
Aprepitant Effects in Intravenous Heroin Dependence
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Dependence
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Current treatments for opioid addiction would benefit by the addition of a non-opioid based treatment medication. Recent behavioral studies have shown that the neurokinin-1 (NK1) receptor is involved ...
Eligibility Criteria
Inclusion
- Male and female subjects ranging in age from 18-55 years who are currently opioid dependent based on meeting DSM-IV criteria for dependence on heroin and who are either treatment or non-treatment seeking individuals.
- Use of intravenous heroin daily for a minimum of 45 days prior to study entry.
- Urine sample (+) for opioids and prior experience with i.v. drug injection.
- Female subjects who are not of childbearing potential, (i.e. post-hysterectomy, or two years post-menopausal) or who are of childbearing potential but will either abstain from heterosexual intercourse and/or practice a medically accepted form of contraception for the study duration.
- Subjects who have experienced significant opioid withdrawal and are familiar with its effects.
- Subjects who are willing to follow the protocol requirements, including methadone and study medication schedules, as evidenced by written informed consent and an ability to read, understand, and complete the study questionnaires.
Exclusion
- Subjects with any significant current axis-1 psychiatric problems, other than those related to drug abuse and opioid dependence, based on a structured psychiatric interview, SCID or MINI, during the screening process.
- Subjects undergoing active treatment for any illness other than chronic stable medical conditions (Patients with HIV and/or taking anti-viral HIV medication without a manifestation of AIDS symptoms are allowed).
- Subjects with clinically significant abnormal findings as determined by medical history, physical examination, vital signs (blood pressure, heart rate, and respiration rate), 02 saturation measure,12-lead ECG, clinical laboratory tests (CBC, chemistry panel), urine drug screen, alcohol breath test, and urine pregnancy test (for females of childbearing potential only).
- Subjects who have any acute organ dysfunction or serious unstable disease states including symptomatic heart, renal or liver disease, COPD, sleep apnea, or encephalitis.
- Subjects with 02 saturation below 90% at screening.
- Subjects taking any concomitant medications (prescription and over-the-counter therapy) including psychotropic medications for the treatment of current major depression, schizophrenia, or mood disorders, as well as medications contraindicated for use with morphine, naltrexone, aprepitant, or methadone.
- Subjects who have received any investigational drug or treatment within the thirty (30) days preceding administration of study medication.
- Females who are nursing, pregnant (as confirmed by a positive urine pregnancy test), or at risk of becoming pregnant.
- Subjects allergic or intolerant to morphine, methadone, naloxone, or aprepitant.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01527994
Start Date
January 1 2012
End Date
February 1 2015
Last Update
August 23 2021
Active Locations (1)
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1
Bellevue Hospital Center & the NYU School of Medicine
New York, New York, United States, 10016