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

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ClinicalTrials.gov Identifier: NCT00726960
Recruitment Status : Unknown
Verified July 2008 by Karolinska University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 1, 2008
Last Update Posted : August 1, 2008
Sponsor:
Collaborators:
Information provided by:

July 30, 2008
August 1, 2008
August 1, 2008
January 2008
December 2009   (Final data collection date for primary outcome measure)
The primary outcome will be self-reported pleasurable opiate effect. [ Time Frame: One week ]
Same as current
No Changes Posted
The secondary outcome will be physiological opiate responses. [ Time Frame: One week ]
Same as current
Not Provided
Not Provided
 
Ability of Aprepitant to Block Opioid Reward in Non-Dependent Opiate Abusers
Modulation of Opiate Reward by NK1 Antagonism: A Laboratory-Based Proof of Concept Study
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Opioid-Related Disorders
  • Heroin Dependence
  • Substance-Related Disorders
  • Drug: aprepitant
    Oral, 125 mg once daily for one week
    Other Name: Emend
  • Drug: Pseudo-placebo - buprenorphine
    Randomized to receive either 8 mg sublingual tablets or 0.4 mg sublingual tablets
    Other Name: Subutex
  • Experimental: 1
    Aprepitant
    Intervention: Drug: aprepitant
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Pseudo-placebo - buprenorphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
June 2010
December 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT00726960
Aprepitant 1
No
Not Provided
Not Provided
Markus Heilig, MD, PhD, Karolinska Universitetssjukhuset
Karolinska University Hospital
  • Ministry of Health and Social Affairs, Sweden
  • County of Stockholm
Principal Investigator: Markus Heilig, MD, PhD Karolinska Universitetssjukhuset
Study Director: Johan Kakko, MD Karolinska Universitetssjukhuset
Karolinska University Hospital
July 2008

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