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Aprepitant Effects in Intravenous Heroin Dependence

NCT01527994 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-08-23

No results posted yet for this study

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.

Conditions

  • Opioid Dependence

Interventions

DRUG

Aprepitant

Aprepitant 125 mg oral tablets

DRUG

Placebo pill

Placebo oral pill- inactive compound

Sponsors & Collaborators

Principal Investigators

  • Stephen Ross, MD · NYU School of Medicine & Bellevue Hospital Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-06-30
Completion
2015-02-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01527994 on ClinicalTrials.gov