PainPhase 1NCT02712554
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
A Phase 1 study testing CL-108 and M366 in people with Pain and Nausea, run by Charleston Laboratories, Inc.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- CL-108 and M366
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Sep 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Being tested
- CL-108, M366, Placebo
- Keywords
- Pain, Nausea, Vomiting
- Medical subject headings
- Pain, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CL-108Drug
Also called Low-dose CL-108 and High-dose CL-108
7.5 mg/325 mg/12.5 mg tablet
M366Drug
Also called Low-dose M366 and High-dose M366
7.5 mg/325 mg tablet
PlaceboDrug
Also called 0 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment A:CL-108 22.5mg/975mg/37.5mg | Experimental | CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth Receives: Drug: CL-108 |
| Treatment B:CL-108 37.5mg/1625mg/62.5mg | Experimental | CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth Receives: Drug: CL-108 |
| Treatment C:M366 22.5mg/975mg | Active comparator | M366 22.5 mg/975 mg tablet by mouth Receives: Drug: M366 |
| Treatment D: M366 37.5mg/1625mg | Active comparator | M366 37.5 mg/1625 mg tablet by mouth Receives: Drug: M366 |
| Treatment E: Placebo | Placebo comparator | Placebo 0 mg tablet by mouth Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Effects: Maximum Effect (Emax) and Minimum Effect (Emin) of High Visual Analog Scale (VAS) in Dose Selection Phase
High VAS measures the positive effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). For VAS assessment, pre-dose (baseline) value was subtracted from each post-dose value prior to calculation of the pharmacodynamic (PD) parameter. Emax is the largest effect score and Emin is the smallest effect score between 0 to 24 hours post-dose.
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours (post-dose)
Subjective Effects: Emax of Any Effects VAS in Dose Selection Phase
Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0 (pre-dose) to 24 hours post-dose.
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours (post-dose)
Emax of Drug Liking VAS in Treatment Phase
Drug liking VAS is the measure of balance of effects that assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar (VAS) anchored in the center with a neutral anchor of 'neither like nor dislike' (score of 50 mm), on the left with 'strong disliking' (score of 0 mm) and on the right with 'strong liking' (score of 100 mm). Emax is the largest effect score between 0.5 to 24 hours post-dose.
Measured: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 24 hours
Secondary outcomes (19)
Number of Adverse Events in Dose Selection Phase
AE=Adverse Event. SAE=Serious adverse event. TEAE=Treatment-emergent adverse event.
Measured: Up to visit 3 (Follow up)
Balance of Effects: Emin of Drug Liking VAS in Treatment Phase
Drug liking VAS is the measure of balance of effects that assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar (VAS) anchored in the center with a neutral anchor of 'neither like nor dislike' (score of 50 mm), on the left with 'strong disliking' (score of 0 mm) and on the right with 'strong liking' (score of 100 mm). Emin is the smallest effect score between 0.5 to 8 hours post-dose.
Measured: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Balance of Effects: Time-averaged Area Under the Effect Curve (TA_AUE) of Drug Liking VAS in Treatment Phase
TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Measured: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Balance of Effects: Emax and Emin of Overall Drug Liking VAS in Treatment Phase
Overall drug liking VAS is the measure of balance of effects that assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100 mm bipolar VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = 'strong disliking', 50 mm = 'neither like nor dislike', and 100 mm = 'strong liking'). Emax is the largest effect score and Emin is the smallest effect score between 0 to 8 hours post-dose.
Measured: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Balance of Effects: Emax and Emin of Take Drug Again VAS in Treatment Phase
Take drug again VAS is the measure of balance of effects. It is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm bipolar VAS with score ranging from 0 mm to 100 mm (0 mm = 'definitely not', 50 mm = 'do not care', and 100 mm = 'definitely so'). Emax is the largest effect score and Emin is the smallest effect score between 0 to 8 hours post-dose.
Measured: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Positive Effects: Emax of High VAS in Treatment Phase
High VAS measures the positive effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). For VAS assessment, pre-dose (baseline) value was subtracted from each post-dose value prior to calculation of the pharmacodynamic (PD) parameter. Emax is the largest effect score between 0 to 8 hours.
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
Positive Effects: TA_AUE of High VAS in Treatment Phase
TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
Positive Effects: Emax of Good Effects VAS in Treatment Phase
Good drug effects VAS measures the positive effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0.5 to 8 hours post-dose.
Measured: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Positive Effects: TA_AUE of Good Effects VAS in Treatment Phase
TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Measured: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Negative Effects: Emax of Bad Effects VAS in Treatment Phase
Bad effects VAS measures the negative effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0.5 to 8 hrs.
Measured: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Negative Effects: TA_AUE of Bad Effects VAS in Treatment Phase
TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Measured: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Sedative and Other Effects: Emin of Alertness/Drowsiness VAS in Treatment Phase
Alertness/Drowsiness VAS measures the sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of 'neither drowsy nor alert' (score of 50 mm), on the left with 'very drowsy' (score of 0 mm) and on the right with 'very alert' (score of 100 mm). Alertness/Drowsiness VAS was calculated by subtracting pre-dose (baseline) value from each post-dose value. Emin is the smallest effect score between 0 to 8 hours post-dose.
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
Sedative and Other Effects: TA_AUE of Alertness/Drowsiness VAS in Treatment Phase
Alertness/Drowsiness VAS measures the sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of 'neither drowsy nor alert' (score of 50 mm), on the left with 'very drowsy' (score of 0 mm) and on the right with 'very alert' (score of 100 mm). Alertness/Drowsiness VAS was calculated by subtracting pre-dose (baseline) value from each post-dose value. TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using trapezoidal rule.
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
Sedative and Other Effects: Emax of Any Effects VAS in Treatment Phase
Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0.5 to 8 hours post-dose.
Measured: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Sedative and Other Effects: TA_AUE of Any Effects VAS in Treatment Phase
TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Measured: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Objective Measures: Change From Baseline in Choice Reaction Time (CRT) in Treatment Phase
CRT is a computerized 5-choice reaction time test in which the subject must press and hold down a touchscreen button at the bottom of the screen. A yellow spot appeared inside one of 5 yellow circles at the top of the screen. Subjects were to respond to the spot as quickly as they could by letting go of the button and touching the circle where the yellow spot appeared. This was repeated for 30 trials. Lower scores indicate better performance.
Measured: 0 (Baseline, pre-dose), 1, 2, 4, 8 and 24 hours (post-dose)
Change From Baseline in Number of Errors (Any Errors) in CRT Test in Treatment Phase
CRT is a computerized 5-choice reaction time test in which the subject must press and hold down a touchscreen button at the bottom of the screen. A yellow spot appeared inside one of 5 yellow circles at the top of the screen. Subjects were to respond to the spot as quickly as they could by letting go of the button and touching the circle where the yellow spot appeared. This was repeated for 30 trials. Lower scores indicate better performance. CRT also measures error scores and response accuracy. Any Errors is a combination of incorrect location errors, inaccurate response errors, no response errors, and premature errors.
Measured: 0 (Baseline, pre-dose), 1, 2, 4, 8 and 24 hours (post-dose)
Pupillometry: Maximum Pupil Constriction (MPC)
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. Pupil diameter was measured using electronic pupillometer. Measurements were collected under mesopic lighting conditions. For each subject, every effort was made to use the same eye for all assessments throughout the study. MPC is calculated as smallest observed pupil diameter - baseline pupil diameter.
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
Pupillometry: TA_AUE of MPC in Treatment Phase
TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charleston Laboratories, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernard P Schachtel, M.D, Study chair, Charleston Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712554
- Sponsor's protocol ID
- CLCT-007
- Status last verified
- Oct 2019
- First submitted
- 15 Mar 2016
- Last updated
- 14 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02712554
- Acronym / sponsor ID
- CLCT-007
- Keywords
- Pain, Nausea, Vomiting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Charleston Laboratories, IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Posted 14 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment A:CL-108 22.5mg/975mg/37.5mg | Experimental | Drug: CL-108CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth |
| Treatment B:CL-108 37.5mg/1625mg/62.5mg | Experimental | Drug: CL-108CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth |
| Treatment C:M366 22.5mg/975mg | Active comparator | Drug: M366M366 22.5 mg/975 mg tablet by mouth |
| Treatment D: M366 37.5mg/1625mg | Active comparator | Drug: M366M366 37.5 mg/1625 mg tablet by mouth |
| Treatment E: Placebo | Placebo comparator | Drug: PlaceboPlacebo 0 mg tablet by mouth |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CL-108Also: Low-dose CL-108 and High-dose CL-1087.5 mg/325 mg/12.5 mg tablet | Drug | Treatment A:CL-108 22.5mg/975mg/37.5mg, Treatment B:CL-108 37.5mg/1625mg/62.5mg |
| M366Also: Low-dose M366 and High-dose M3667.5 mg/325 mg tablet | Drug | Treatment C:M366 22.5mg/975mg, Treatment D: M366 37.5mg/1625mg |
| PlaceboAlso: 0 mg tablet | Drug | Treatment E: Placebo |
Primary outcome
Subjective Effects: Maximum Effect (Emax) and Minimum Effect (Emin) of High Visual Analog Scale (VAS) in Dose Selection Phase
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours (post-dose)
High VAS measures the positive effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). For VAS assessment, pre-dose (baseline) value was subtracted from each post-dose value prior to calculation of the pharmacodynamic (PD) parameter. Emax is the largest effect score and Emin is the smallest effect score between 0 to 24 hours post-dose.
Subjective Effects: Emax of Any Effects VAS in Dose Selection Phase
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours (post-dose)
Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0 (pre-dose) to 24 hours post-dose.
Emax of Drug Liking VAS in Treatment Phase
Time frame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 24 hours
Drug liking VAS is the measure of balance of effects that assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar (VAS) anchored in the center with a neutral anchor of 'neither like nor dislike' (score of 50 mm), on the left with 'strong disliking' (score of 0 mm) and on the right with 'strong liking' (score of 100 mm). Emax is the largest effect score between 0.5 to 24 hours post-dose.
19 secondary outcomes
Number of Adverse Events in Dose Selection Phase
Time frame: Up to visit 3 (Follow up)
Balance of Effects: Emin of Drug Liking VAS in Treatment Phase
Time frame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Balance of Effects: Time-averaged Area Under the Effect Curve (TA_AUE) of Drug Liking VAS in Treatment Phase
Time frame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Balance of Effects: Emax and Emin of Overall Drug Liking VAS in Treatment Phase
Time frame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Balance of Effects: Emax and Emin of Take Drug Again VAS in Treatment Phase
Time frame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Positive Effects: Emax of High VAS in Treatment Phase
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
Positive Effects: TA_AUE of High VAS in Treatment Phase
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
Positive Effects: Emax of Good Effects VAS in Treatment Phase
Time frame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Positive Effects: TA_AUE of Good Effects VAS in Treatment Phase
Time frame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Negative Effects: Emax of Bad Effects VAS in Treatment Phase
Time frame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Negative Effects: TA_AUE of Bad Effects VAS in Treatment Phase
Time frame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Sedative and Other Effects: Emin of Alertness/Drowsiness VAS in Treatment Phase
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
Sedative and Other Effects: TA_AUE of Alertness/Drowsiness VAS in Treatment Phase
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
Sedative and Other Effects: Emax of Any Effects VAS in Treatment Phase
Time frame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Sedative and Other Effects: TA_AUE of Any Effects VAS in Treatment Phase
Time frame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Objective Measures: Change From Baseline in Choice Reaction Time (CRT) in Treatment Phase
Time frame: 0 (Baseline, pre-dose), 1, 2, 4, 8 and 24 hours (post-dose)
Change From Baseline in Number of Errors (Any Errors) in CRT Test in Treatment Phase
Time frame: 0 (Baseline, pre-dose), 1, 2, 4, 8 and 24 hours (post-dose)
Pupillometry: Maximum Pupil Constriction (MPC)
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
Pupillometry: TA_AUE of MPC in Treatment Phase
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard P Schachtel, M.D study chair
Charleston Laboratories
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CL-108 and M366 in people with Pain and Nausea, run by Charleston Laboratories, Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Effects: Maximum Effect (Emax) and Minimum Effect (Emin) of High Visual Analog Scale (VAS) in Dose Selection Phase (time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours (post-dose)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019; AzTrials last refreshed its copy on 26 Oct 2026.