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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Karolinska University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Ministry of Health and Social Affairs, Sweden
County of Stockholm
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT00726960
First received: July 30, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome will be physiological opiate responses. [ Time Frame: One week ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Markus Heilig, MD, PhD, Karolinska Universitetssjukhuset
ClinicalTrials.gov Identifier: NCT00726960     History of Changes
Other Study ID Numbers: Aprepitant 1
Study First Received: July 30, 2008
Last Updated: July 30, 2008
Health Authority: Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Aprepitant
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Antiemetics
Autonomic Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 26, 2014