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

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

Outcome

Missed primary endpoint

registry Treatment A: CL-108 22.5 mg/975 mg/37.5 mg vs Treatment C: M366 22.5 mg/975 mg; p = 0.2344; ANOVA NCT02712554 ↗

registry Treatment B: CL-108 37.5 mg/1625 mg/62.5 mg vs Treatment D: M366 37.5 mg/1625 mg; p = 0.4737; ANOVA NCT02712554 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
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.