drugset / Trial / NCT02413281

A Study of the Abuse Liability Potential of ALKS 5461 in Healthy, Non-Dependent, Recreational Opioid Users

NCT02413281 ↗

Phase 1 Completed 56 enrolled Alkermes, Inc.
RandomizedCrossoverDouble-blindTreatment

Summary

This study will evaluate the abuse potential of ALKS 5461.

Timeline

Start
2015-03
Primary completion
2015-09
Completion
2015-09

Outcome

Met primary endpoint

paper Drug Liking Emax for all BUP/SAM doses were significantly lower than those observed for either buprenorphine dose alone. PMID 30102427 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Buprenorphine Other / unclassified 2 mg Other
Comparator Buprenorphine Other / unclassified 8 mg Other
Comparator Buprenorphine Other / unclassified 16 mg Other
Subject Samidorphan Small molecule 2 mg Other
Subject Samidorphan Small molecule 8 mg Other
Subject Samidorphan Small molecule 16 mg Other

Indications

No indication recorded.