CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
CL-108 +2 moredrug
Likely dose
CL-108 7.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02712554
NCT02712554Phase 1Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo and Active-Controlled, Crossover 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

Charleston Laboratories, Inc·interventional·Posted Mar 18, 2016·Updated Oct 14, 2019

In Brief

A Phase 1 clinical trial evaluating CL-108, M366, and 1 other intervention for Pain and 2 related conditions. Completed, enrolled 40 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Nausea, Vomiting
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 18, 2016
Enrollment StartJun 1, 2015
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.3 years ago

Interventions

CL-108drug

7.5 mg/325 mg/12.5 mg tablet

M366drug

7.5 mg/325 mg tablet

Placebodrug