Multi-site, randomized, double-blind, repeat-dose Phase 2 study to evaluate the degree and duration of action of multiple doses of CAM2038 in blocking the effects of hydromorphone in patients with moderate or severe opioid use disorder.
This is a multi-site, randomized, double-blind, repeat-dose Phase 2 study to evaluate the degree and duration of action of multiple doses of CAM2038 q1w in blocking the effects of a mu opioid agonist (hydromorphone) in patients with moderate or severe opioid use disorder. The study will involve 4 phases: Screening, Qualification, Treatment, and Follow-up. The study will enroll a sufficient number of subjects to ensure that at least 48 subjects complete the study (24 subjects per group with at least 16 females in total). Replacement subjects may be added at the discretion of the sponsor with the agreement of the investigator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
47
CAM2038 subcutaneous injection
Vince and Associates Clinical Research
Overland Park, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
New York Psychiatric Institute
New York, New York, United States
Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg
Treatment Phase Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Baseline and Four Challenge sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.
Time frame: 17 days
Treatment Phase Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 32 mg
Treatment Phase Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Baseline and Four Challenge sessions Compared to Baseline (Completer Population), where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.
Time frame: 17 days
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) for Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 24 mg
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Qualification/Baseline and Four Challenge sessions (Completer Population) for CAM2038 q1w, 24 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.
Time frame: 17 days
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 32 mg
Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Qualification/Baseline and Four Challenge sessions (Completer Population) for CAM2038 q1w, 32 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome.
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Time frame: 17 days
Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) comparing hydromorphone challenge doses in each of the baseline and four challenge sequence with each other, presented as Least Squares (LS) Mean with Standard Error (SE) and 95% Confidence Interval (CI). VAS item "At this moment, I feel high" where values can range from 0 (Not at all High) to 100 (Extremely High).
Time frame: 15 days
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) comparing hydromorphone challenge doses in each of the baseling and four challenge sequences with each other, presented as Least Squares (LS) Mean with Standard Error (SE) and 95% Confidence Interval (CI). VAS item "At this moment, I feel good drug effects" where values can range from 0 (Not at all ) to 100 (Extremely).
Time frame: 15 days
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w Group (Completer Population)
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w group (Completer Population) , presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item "At this moment, I feel bad effects" where values can range from 0 (Not at all) to 100 (Extremely).
Time frame: 15 days
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w Group (Completer Population)
Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w group (Completer Population) , presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item "At this moment, I feel bad effects" where values can range from 0 (Not at all) to 100 (Extremely).
Time frame: 15 days
Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Analysis Results for Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) comparing hydromorphone challenge doses in each of the baseline and four challenge sequence with each other, presented as Least Squares (LS) Mean with Standard Error (SE) and 95% Confidence Interval (CI). VAS item "At this moment, I desire opiods" where values can range from 0 (Definitely not) to 100 (Definitely so).
Time frame: 15 days
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item "At this moment, my mental state is" where values can range from 0 (Very Drowsy) to 100 (Very alert), with 50 being neutral (Neither drowsy nor alert).
Time frame: 15 days
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item "At this moment, I fell any drug effects" where values can range from 0 (Not at all) to 100 (Extremely).
Time frame: 15 days