Title
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
Phase
Phase 1Lead Sponsor
Karolinska InstituteStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Opioid-Related Disorders Heroin Dependence Substance-Related DisordersIntervention/Treatment
buprenorphine aprepitant ...Study Participants
60The 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.
Oral, 125 mg once daily for one week
Randomized to receive either 8 mg sublingual tablets or 0.4 mg sublingual tablets
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.
