Phase 1
N=12
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
Pain · Nausea · Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT02712554 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Subjective Effects: Maximum Effect (Emax) and Minimum Effect (Emin) of High Visual Analog Scale (VAS) in Dose Selection Phase — 85.0; 42.0; 75.5; 94.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- CL-108 (Drug); M366 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Charleston Laboratories, Inc
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Effects: Maximum Effect (Emax) and Minimum Effect (Emin) of High Visual Analog Scale (VAS) in Dose Selection Phase |
85.0; 42.0; 75.5; 94.0; 2.3; 3.0 | — |
| PRIMARY Subjective Effects: Emax of Any Effects VAS in Dose Selection Phase |
86.0; 48.5; 75.0; 94.0; 4.3 | — |
| PRIMARY Emax of Drug Liking VAS in Treatment Phase |
77.3; 81.4; 74.4; 79.8; 54.5 | <0.0001 sig |
| SECONDARY Number of Adverse Events in Dose Selection Phase |
16; 14; 0; 0 | — |
| SECONDARY Balance of Effects: Emin of Drug Liking VAS in Treatment Phase |
49.0; 46.6; 44.8; 46.5; 47.1 | — |
| SECONDARY Balance of Effects: Time-averaged Area Under the Effect Curve (TA_AUE) of Drug Liking VAS in Treatment Phase |
12.071; 13.772; 9.773; 11.162; 1.183 | — |
| SECONDARY Balance of Effects: Emax and Emin of Overall Drug Liking VAS in Treatment Phase |
70.4; 75.8; 65.2; 71.1; 52.2; 61.2 | <.0001 sig |
| SECONDARY Balance of Effects: Emax and Emin of Take Drug Again VAS in Treatment Phase |
74.6; 75.2; 68.9; 71.3; 51.1; 66.4 | <.0001 sig |
| SECONDARY Positive Effects: Emax of High VAS in Treatment Phase |
58.9; 71.8; 54.6; 67.5; 5.4 | <.0001 sig |
| SECONDARY Positive Effects: TA_AUE of High VAS in Treatment Phase |
1.055; 27.850; 36.363; 24.500; 32.050 | <.0001 sig |
| SECONDARY Positive Effects: Emax of Good Effects VAS in Treatment Phase |
6.3; 59.3; 68.3; 52.5; 62.2 | <.0001 sig |
| SECONDARY Positive Effects: TA_AUE of Good Effects VAS in Treatment Phase |
28.108; 34.894; 25.541; 29.327; 1.140 | <.0001 sig |
| SECONDARY Negative Effects: Emax of Bad Effects VAS in Treatment Phase |
14.8; 30.1; 20.1; 36.1; 2.4 | <0.001 sig |
| SECONDARY Negative Effects: TA_AUE of Bad Effects VAS in Treatment Phase |
5.487; 12.535; 7.171; 13.830; 0.217 | 0.0001 sig |
| SECONDARY Sedative and Other Effects: Emin of Alertness/Drowsiness VAS in Treatment Phase |
25.3; 20.2; 33.3; 27.9; 47.9 | 0.0001 sig |
| SECONDARY Sedative and Other Effects: TA_AUE of Alertness/Drowsiness VAS in Treatment Phase |
-12.103; -16.919; -6.751; -8.737; -0.348 | 0.0024 sig |
| SECONDARY Sedative and Other Effects: Emax of Any Effects VAS in Treatment Phase |
62.4; 71.9; 55.4; 68.9; 7.4 | <0.0001 sig |
| SECONDARY Sedative and Other Effects: TA_AUE of Any Effects VAS in Treatment Phase |
29.720; 38.504; 26.371; 34.030; 1.537 | <0.0001 sig |
| SECONDARY Objective Measures: Change From Baseline in Choice Reaction Time (CRT) in Treatment Phase |
74.0; 51.9; 51.2; 56.8; 55.0; -7.0 | — |
| SECONDARY Change From Baseline in Number of Errors (Any Errors) in CRT Test in Treatment Phase |
0.6; 0.4; 0.5; 0.8; 0.90; 0.1 | — |
| SECONDARY Pupillometry: Maximum Pupil Constriction (MPC) |
2.51; 3.15; 2.34; 2.75; 0.39 | <0.0001 sig |
| SECONDARY Pupillometry: TA_AUE of MPC in Treatment Phase |
1.565; 2.355; 1.317; 1.888; -0.153 | <0.0001 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT02712554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.