drugset / Trial / NCT02712554

A Study in Opioid-Experienced, Non-Dependent Recreational Drug Users to Determine the Abuse Potential and Safety of CL-108 Tablets Administered Via the Oral Route

NCT02712554

Phase 1 Completed 40 enrolled Charleston Laboratories, Inc
RandomizedCrossoverDouble-blindBasic science

Summary

The purpose of this study is to assess the abuse potential of CL-108 tablets, including the abuse deterrent effects of promethazine, following oral administration, relative to hydrocodone/acetaminophen (APAP) tablets and placebo in non-dependent, recreational opioid users.

Timeline

Start
2015-06
Primary completion
2015-09
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject CL-108 Unknown 22.5 mg Oral
Subject CL-108 Unknown 37.5 mg Oral
Comparator M366 Unknown 22.5 mg Oral
Comparator M366 Unknown 37.5 mg Oral

Indications

No indication recorded.