Clinical trial NCT02712554: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Nausea
Vomiting
Keywords: Pain
Nausea
Vomiting
Lead sponsor: Charleston Laboratories, Inc
Sponsor class: INDUSTRY
First posted: 2016-03-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Subjective Effects: Maximum Effect (Emax) and Minimum Effect (Emin) of High Visual Analog Scale (VAS) in Dose Selection Phase
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours (post-dose)
measure: Subjective Effects: Emax of Any Effects VAS in Dose Selection Phase
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours (post-dose)
measure: Emax of Drug Liking VAS in Treatment Phase
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 24 hours
Secondary outcomes:
measure: Number of Adverse Events in Dose Selection Phase
timeFrame: Up to visit 3 (Follow up)
measure: Balance of Effects: Emin of Drug Liking VAS in Treatment Phase
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
measure: Balance of Effects: Time-averaged Area Under the Effect Curve (TA_AUE) of Drug Liking VAS in Treatment Phase
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
measure: Balance of Effects: Emax and Emin of Overall Drug Liking VAS in Treatment Phase
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
measure: Balance of Effects: Emax and Emin of Take Drug Again VAS in Treatment Phase
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
measure: Positive Effects: Emax of High VAS in Treatment Phase
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
measure: Positive Effects: TA_AUE of High VAS in Treatment Phase
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
measure: Positive Effects: Emax of Good Effects VAS in Treatment Phase
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
measure: Positive Effects: TA_AUE of Good Effects VAS in Treatment Phase
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
measure: Negative Effects: Emax of Bad Effects VAS in Treatment Phase
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
measure: Negative Effects: TA_AUE of Bad Effects VAS in Treatment Phase
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
measure: Sedative and Other Effects: Emin of Alertness/Drowsiness VAS in Treatment Phase
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
measure: Sedative and Other Effects: TA_AUE of Alertness/Drowsiness VAS in Treatment Phase
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
measure: Sedative and Other Effects: Emax of Any Effects VAS in Treatment Phase
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
measure: Sedative and Other Effects: TA_AUE of Any Effects VAS in Treatment Phase
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
measure: Objective Measures: Change From Baseline in Choice Reaction Time (CRT) in Treatment Phase
timeFrame: 0 (Baseline, pre-dose), 1, 2, 4, 8 and 24 hours (post-dose)
measure: Change From Baseline in Number of Errors (Any Errors) in CRT Test in Treatment Phase
timeFrame: 0 (Baseline, pre-dose), 1, 2, 4, 8 and 24 hours (post-dose)
measure: Pupillometry: Maximum Pupil Constriction (MPC)
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
measure: Pupillometry: TA_AUE of MPC in Treatment Phase
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
Other outcomes:
Locations:
Study officials:
affiliation: Charleston Laboratories
name: Bernard P Schachtel, M.D
role: STUDY_CHAIR
References: