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

Charleston Laboratories

Status and phase: Completed; Phase 1

Conditions: Vomiting; Nausea; Pain

Treatments: Drug: M366; Drug: CL-108; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02712554

CLCT-007

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 5 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Drug: CL-108

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

Experimental group

Description:

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

Treatment:

Drug: CL-108

Treatment C:M366 22.5mg/975mg

Active Comparator group

Description:

M366 22.5 mg/975 mg tablet by mouth

Treatment:

Drug: M366

Treatment D: M366 37.5mg/1625mg

Active Comparator group

Description:

M366 37.5 mg/1625 mg tablet by mouth

Treatment:

Drug: M366

Treatment E: Placebo

Placebo Comparator group

Description:

Placebo 0 mg tablet by mouth

Treatment:

Drug: Placebo