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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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; to assess the cognitive and behavioral effects of CL-108 tablets following oral administration relative to hydrocodone/APAP tablets and placebo in non-dependent, recreational opioid users; and to assess the safety of orally administered CL-108 tablets relative to hydrocodone/APAP tablets and placebo in non-dependent, recreational opioid users.

Conditions

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Pain Nausea Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment A:CL-108 22.5mg/975mg/37.5mg

CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth

Group Type EXPERIMENTAL

CL-108

Intervention Type DRUG

7.5 mg/325 mg/12.5 mg tablet

Treatment B:CL-108 37.5mg/1625mg/62.5mg

CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth

Group Type EXPERIMENTAL

CL-108

Intervention Type DRUG

7.5 mg/325 mg/12.5 mg tablet

Treatment C:M366 22.5mg/975mg

M366 22.5 mg/975 mg tablet by mouth

Group Type ACTIVE_COMPARATOR

M366

Intervention Type DRUG

7.5 mg/325 mg tablet

Treatment D: M366 37.5mg/1625mg

M366 37.5 mg/1625 mg tablet by mouth

Group Type ACTIVE_COMPARATOR

M366

Intervention Type DRUG

7.5 mg/325 mg tablet

Treatment E: Placebo

Placebo 0 mg tablet by mouth

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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CL-108

7.5 mg/325 mg/12.5 mg tablet

Intervention Type DRUG

M366

7.5 mg/325 mg tablet

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Low-dose CL-108 and High-dose CL-108 Low-dose M366 and High-dose M366 0 mg tablet

Eligibility Criteria

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Inclusion Criteria

* BMI within 18.0 to 33.0 kg/m2, inclusive (minimum weight of 50.0 kg at Screening)
* Healthy, as determined by no clinically significant medical history, physical examination findings, 12-lead ECG findings, vital signs measurements, and laboratory results at screening, as judged by the investigator
* Current opioid users who had used oral opioids for recreational (non-therapeutic) purposes, at least 10 times in the past year

Exclusion Criteria

* Drug or alcohol dependence within the last 12 months (except nicotine)
* Subjects who had ever been in treatment for substance use disorders (except smoking cessation
* History of presence of any clinically significant cardiac, neurologic, pulmonary, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, dermatologic, renal, or other major disease at screening, which in the opinion of the investigator, would have jeopardized the safety of the subject or the validity of the study results
* History or presence of hypotension, judged to be clinically significant based on investigator judgement

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes