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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-10-14

Study results available
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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.

Conditions

Interventions

DRUG

CL-108

7.5 mg/325 mg/12.5 mg tablet

DRUG

M366

7.5 mg/325 mg tablet

DRUG

Placebo

Sponsors & Collaborators

  • Charleston Laboratories, Inc

    lead INDUSTRY

Principal Investigators

  • Bernard P Schachtel, M.D · Charleston Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-09-30
Completion
2015-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02712554 on ClinicalTrials.gov