Aprepitant Effects in Intravenous Heroin Dependence

Opioid Dependence Clinical Trial

Official title:

Clinical Laboratory Evaluations of Aprepitant for the Treatment of Opioid Dependence: Inpatient Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527994
• Other study ID #: 09-0457
• Secondary ID: 5R01DA027151-02
• Status: Completed
• Phase: Phase 1
• Start date: January 2012
• Est. completion date: February 2015

Study information

• Verified date: August 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heroin Dependence
• Opioid Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Aprepitant
Aprepitant 125 mg oral tablets
• Placebo pill
Placebo oral pill- inactive compound

Locations

Country	Name	City	State
United States	Bellevue Hospital Center & the NYU School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Withdrawal	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	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
Secondary	Opioid Intoxication	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	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
Secondary	Neuro-economic Choice Procedure	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	45 minutes post challenge drug dosing