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Ability of Aprepitant to Block Opioid Reward in Non-Dependent Opiate Abusers

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2008 by Karolinska University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00726960
First Posted: August 1, 2008
Last Update Posted: August 1, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ministry of Health and Social Affairs, Sweden
County of Stockholm
Information provided by:
Karolinska University Hospital
  Purpose
The objective of this study is to determine whether aprepitant blocks the opiate reward system in non-dependent opiate abusers, indicating its potential as a safe, non-addictive first line therapy for early heroin abuse.

Condition Intervention Phase
Opioid-Related Disorders Heroin Dependence Substance-Related Disorders Drug: aprepitant Drug: Pseudo-placebo - buprenorphine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Modulation of Opiate Reward by NK1 Antagonism: A Laboratory-Based Proof of Concept Study

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • The primary outcome will be self-reported pleasurable opiate effect. [ Time Frame: One week ]

Secondary Outcome Measures:
  • The secondary outcome will be physiological opiate responses. [ Time Frame: One week ]

Estimated Enrollment: 60
Study Start Date: January 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Aprepitant
Drug: aprepitant
Oral, 125 mg once daily for one week
Other Name: Emend
Placebo Comparator: 2
Placebo
Drug: Pseudo-placebo - buprenorphine
Randomized to receive either 8 mg sublingual tablets or 0.4 mg sublingual tablets
Other Name: Subutex

Detailed Description:
This initial proof-of-concept study focuses on evaluating whether an NK1 antagonist, aprepitant, can block opiate reward in non-dependent opiate experienced volunteers in response to a standard opiate challenge. Sixty subjects will be included in a randomized controlled study. Following a training challenge session, they will receive 1 week treatment with aprepitant or matching placebo, followed by a challenge session during which subjective and physiological responses to the opiate partial agonist buprenorphine will be assessed.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 - 50
  • Current opiate use, without dependence

Exclusion Criteria:

  • Clinical diagnosis of opiate dependence
  • Positive urine screen for opiates on day of challenge sessions
  • Meet diagnostic criteria for any other substance abuse disorder except nicotine within the last 12 months.
  • Any ongoing prescription medication other than oral contraceptives or hormone replacement
  • Any serious medical condition which in the judgment of the investigators makes administration of opiates medically inappropriate.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00726960


Locations
Sweden
Karolinska University Hospital, Huddinge
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
Ministry of Health and Social Affairs, Sweden
County of Stockholm
Investigators
Principal Investigator: Markus Heilig, MD, PhD Karolinska Universitetssjukhuset
Study Director: Johan Kakko, MD Karolinska Universitetssjukhuset
  More Information

Responsible Party: Markus Heilig, MD, PhD, Karolinska Universitetssjukhuset
ClinicalTrials.gov Identifier: NCT00726960     History of Changes
Other Study ID Numbers: Aprepitant 1
First Submitted: July 30, 2008
First Posted: August 1, 2008
Last Update Posted: August 1, 2008
Last Verified: July 2008

Keywords provided by Karolinska University Hospital:
Heroin abuse
Opioids
Opiates
Substance abuse
Addiction

Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Opioid-Related Disorders
Heroin Dependence
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Aprepitant
Fosaprepitant
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action