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Aprepitant Effects in Intravenous Heroin Dependence

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ClinicalTrials.gov Identifier: NCT01527994
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : April 14, 2015
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Stephen Ross, New York University

Tracking Information
First Submitted Date  ICMJE January 9, 2012
First Posted Date  ICMJE February 7, 2012
Last Update Posted Date April 14, 2015
Study Start Date  ICMJE January 2012
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2012)
Opioid Withdrawal [ Time Frame: 30 minutes pre-medication, 150 minutes post medication, 15 minutes post-challenge drug administration, 1 hour post- challenge drug administration, 2 hours post challenge drug administration and 3.5 hours post challenge drug administration ]
On the 4 dosing days, opioid withdrawal will be measured using the Clinical Opiate Withdrawal Scale (COWS) and the Subjective Opioid Withdrawal Scale (SOWS) at the following time points: 30 minutes pre-medication, 150 minutes post medication, 15 minutes post-challenge drug administration, 1 hour post- challenge drug administration, 2 hours post challenge drug administration and 3.5 hours post challenge drug administration
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01527994 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2012)
  • Opioid Intoxication [ Time Frame: 30 minutes pre-medication, 150 minutes post medication, 15 minutes post-challenge drug administration, 1 hour post- challenge drug administration, 2 hours post challenge drug administration and 3.5 hours post challenge drug administration ]
    On the 4 dosing days, opioid intoxication will be measured using the Visual Anaglog Scale (VAS)at the following time points: 30 minutes pre-medication, 150 minutes post medication, 15 minutes post-challenge drug administration, 1 hour post- challenge drug administration, 2 hours post challenge drug administration and 3.5 hours post challenge drug administration
  • Neuro-economic Choice Procedure [ Time Frame: 45 minutes post challenge drug dosing ]
    A neuro-economics collaborative team will perform a neuro-economic choice paradigm procedure at 45 minutes post challenge drug dosing to determine the relative proportion and amount of a further dose of drug at 3.5 hours post challenge drug administration versus receipt of a variable amount of money
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aprepitant Effects in Intravenous Heroin Dependence
Official Title  ICMJE Clinical Laboratory Evaluations of Aprepitant for the Treatment of Opioid Dependence: Inpatient Test
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 in opioid reward and withdrawal. This study proposes to study a potential non-opioid treatment, the clinically available, FDA approved, NK1 antagonist aprepitant, in opioid addicted patients. Based on the unique behavioral and pharmacological characteristics of opioid addiction, and what is known of the currently employed treatments, the investigators propose that the therapeutic mechanism of any potential opioid addiction treatment medication must include the ability to reduce opioid withdrawal. This is of particular importance during treatment initiation (eg. detoxification). In addition, for long-term treatment and relapse prevention, it is important to manage drug craving and inhibit the rewarding effects of opioids if patients do experience a slip. Therefore, the investigators propose to study aprepitant using human models of opioid withdrawal, craving and acute opioid reward and reinforcement. The investigators will also include a neuro-economics choice procedure paradigm.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Opioid Dependence
Intervention  ICMJE
  • Drug: Aprepitant
    Aprepitant 125 mg oral tablets
    Other Name: Brand name: Emend
  • Drug: Placebo pill
    Placebo oral pill- inactive compound
Study Arms  ICMJE
  • Experimental: Aprepitant 125 mg
    Day Number Dose Procedure Day 0 Aprepitant 125mg Admitting Medication Treatment Day 1 Aprepitant 125mg Saline-Saline Day 2 Aprepitant 125mg Morphine-Morphine Day 3 Aprepitant 125mg Saline-Morphine Day 4 Aprepitant 125mg Naloxone-Morphine and Discharge
    Intervention: Drug: Aprepitant
  • Placebo Comparator: Placebo
    Day Number Dose Procedure Day 0 placebo Admitting Medication Treatment Day 1 placebo Saline-Saline Day 2 placebo Morphine-Morphine Day 3 placebo Saline-Morphine Day 4 placebo Naloxone-Morphine and Discharge
    Intervention: Drug: Placebo pill
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2015)
64
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2012)
28
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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.
  2. Use of intravenous heroin daily for a minimum of 45 days prior to study entry.
  3. Urine sample (+) for opioids and prior experience with i.v. drug injection.
  4. 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.
  5. Subjects who have experienced significant opioid withdrawal and are familiar with its effects.
  6. 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 Criteria:

  1. 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.
  2. 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).
  3. 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).
  4. Subjects who have any acute organ dysfunction or serious unstable disease states including symptomatic heart, renal or liver disease, COPD, sleep apnea, or encephalitis.
  5. Subjects with 02 saturation below 90% at screening.
  6. 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.
  7. Subjects who have received any investigational drug or treatment within the thirty (30) days preceding administration of study medication.
  8. Females who are nursing, pregnant (as confirmed by a positive urine pregnancy test), or at risk of becoming pregnant.
  9. Subjects allergic or intolerant to morphine, methadone, naloxone, or aprepitant.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01527994
Other Study ID Numbers  ICMJE 09-0457
5R01DA027151-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephen Ross, New York University
Study Sponsor  ICMJE New York University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Stephen Ross, MD NYU School of Medicine & Bellevue Hospital Center
PRS Account New York University
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP