A Phase 1 interventional study of aprepitant and Pseudo-placebo - buprenorphine in Opioid-Related Disorders, Heroin Dependence and Substance-Related Disorders, sponsored by Karolinska University Hospital. Status unknown at 1 site in Sweden. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2008-08-01.
Sponsored by Karolinska University Hospital · Phase 1, Interventional, and Treatment
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.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's planned enrollment of 60 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
Aprepitant
Drug: aprepitant
Placebo
Drug: Pseudo-placebo - buprenorphine
Oral, 125 mg once daily for one week
Also known as: Emend
Randomized to receive either 8 mg sublingual tablets or 0.4 mg sublingual tablets
Also known as: Subutex
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
This study is status unknown, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.
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Karolinska University Hospital