Ability of Aprepitant to Block Opioid Reward in Non-Dependent Opiate Abusers
This trial is active, not recruiting.
|Conditions||opioid-related disorders, heroin dependence, substance-related disorders|
|Treatments||aprepitant, pseudo-placebo - buprenorphine|
|Sponsor||Karolinska University Hospital|
|Collaborator||Ministry of Health and Social Affairs, Sweden|
|Start date||January 2008|
|End date||December 2009|
|Trial size||60 participants|
|Trial identifier||NCT00726960, Aprepitant 1|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Masking||double blind (subject, investigator)|
The primary outcome will be self-reported pleasurable opiate effect.
time frame: One week
The secondary outcome will be physiological opiate responses.
time frame: One week
Male or female participants from 18 years up to 50 years old.
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.
|Official title||Modulation of Opiate Reward by NK1 Antagonism: A Laboratory-Based Proof of Concept Study|
|Principal investigator||Markus Heilig, MD, PhD|
|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.|
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