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A Multiple Dose Opioid Challenge Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02611752
Recruitment Status : Completed
First Posted : November 23, 2015
Results First Posted : November 14, 2019
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
Braeburn Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Moderate or Severe Opioid Use Disorder
Intervention Drug: CAM2038
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CAM2038 q1w, 24 mg CAM2038 q1w, 32 mg
Hide Arm/Group Description CAM2038 once weekly 24 mg subcutaneous injection will be administered on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg and 18 mg intramuscular injection will be subsequently administered during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13 CAM2038 once weekly 32 mg subcutaneous injection will be administered on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg and 18 mg intramuscular injection will be subsequently administered during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13
Period Title: Overall Study
Started 22 25
Day 1-3 Hydromorphone Challenge Injs 22 25
Day 4-6 Hydromorphone Challenge Injs 22 24
Day 8-10 Hydromorphone Challenge Injs 22 24
Day11-13 Hydromorphone Challenge Injs 22 24
Completed 22 24
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Arm/Group Title CAM2038 q1w, 24 mg CAM2038 q1w, 32 mg Total
Hide Arm/Group Description CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13. CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during 4 challenge sessions on Days 1-3, 4-6, 8-10 and 11-13. Total of all reporting groups
Overall Number of Baseline Participants 22 25 47
Hide Baseline Analysis Population Description
A summary of demographics and baseline characteristics will be presented by treatment arm for safety population. The demographic characteristics will consist of age, sex, ethnicity, and race us.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 25 participants 47 participants
36.1  (9.3) 35.6  (9.1) 35.8  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 25 participants 47 participants
Female
6
  27.3%
6
  24.0%
12
  25.5%
Male
16
  72.7%
19
  76.0%
35
  74.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 25 participants 47 participants
Hispanic or Latino
0
   0.0%
1
   4.0%
1
   2.1%
Not Hispanic or Latino
22
 100.0%
24
  96.0%
46
  97.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 25 participants 47 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
  40.9%
15
  60.0%
24
  51.1%
White
12
  54.5%
10
  40.0%
22
  46.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   4.5%
0
   0.0%
1
   2.1%
BMI, kg/m^2  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 22 participants 25 participants 47 participants
25.2  (4.28) 24.4  (4.25) 24.8  (4.24)
1.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Mean Drug Liking VAS Scores over Time for CAM2038 q1w 24 mg by Hydromorphone Challenge Session, Completer Population (N=22)
Arm/Group Title CAM2038 q1w, 24 mg - Hydromorphone 0 mg CAM2038 q1w, 24 mg - Hydromorphone 6 mg CAM2038 q1w, 24 mg - Hydromorphone 18 mg
Hide Arm/Group Description:
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 6 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
Overall Number of Participants Analyzed 22 22 22
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 50.6  (1.48) 83.2  (1.48) 92.7  (1.48)
Days 1-3 51.3  (0.84) 52.2  (0.84) 53.1  (0.84)
Days 4-6 50.8  (0.84) 52.1  (0.84) 58.3  (0.84)
Days 8 -10 51.1  (0.84) 52.6  (0.84) 52.9  (0.84)
Days 11-13 51.0  (0.84) 51.9  (0.84) 54.6  (0.84)
2.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Mean Drug Liking VAS Scores over Time for CAM2038 q1w 32 mg by Hydromorphone Challenge Session, Completer Population (N=24)
Arm/Group Title CAM2038 q1w, 32 mg - Hydromorphone 0 mg CAM2038 q1w, 32 mg - Hydromorphone 6 mg CAM2038 q1w, 32 mg - Hydromorphone 18 mg
Hide Arm/Group Description:
CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 6 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
Overall Number of Participants Analyzed 24 24 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 52.9  (1.70) 79.6  (1.70) 93.2  (1.70)
Days 1-3 51.6  (1.01) 52.5  (1.01) 54.0  (1.01)
Days 4-6 51.5  (1.01) 53.0  (1.01) 56.0  (1.01)
Days 8 -10 51.7  (1.01) 52.3  (1.01) 54.2  (1.01)
Days 11-13 51.2  (1.01) 52.1  (1.01) 54.8  (1.01)
3.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Mean Drug Liking VAS Scores over Time for CAM2038 q1w 24 mg by Hydromorphone Challenge Session, Completer Population (N=22)
Arm/Group Title CAM2038 q1w, 24 mg - Hydromorphone 6 Mg-Hydromorphone 0 mg CAM2038 q1w, 24 mg - Hydromorphone 18 mg- Hydromorphone 0mg CAM2038 q1w, 24 mg - Hydromorphone 18 mg- Hydromorphone 6 mg
Hide Arm/Group Description:
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) and 6 mg intramuscular injection will be administered on 2 of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg and Hydromorphone 0 mg intramuscular injection will be administered on 2 of the 3 days during baseline and 4 challenge sessions on Days -3--1,1-3, 4-6, 8-10 and 11-13.
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg and Hydromorphone 6 mg intramuscular injection will be administered on 2 of the 3 days during baseline and 4 challenge sessions on Days -3--1,1-3, 4-6, 8-10 and 11-13.
Overall Number of Participants Analyzed 22 22 22
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Qualification/Baseline 32.7  (1.90) 42.1  (1.90) 9.5  (1.90)
Days 1-3 0.9  (1.12) 1.8  (1.12) 0.9  (1.12)
Days 4-6 1.3  (1.12) 7.4  (1.12) 6.2  (1.12)
Days 8 -10 1.5  (1.12) 1.8  (1.12) 0.3  (1.12)
Days 11-13 0.9  (1.12) 3.6  (1.12) 2.7  (1.12)
4.Primary Outcome
Title 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
Hide Description 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.
Time Frame 17 days
Hide Outcome Measure Data
Hide Analysis Population Description
Mean Drug Liking VAS Scores over Time for CAM2038 q1w 32 mg by Hydromorphone Challenge Session, Completer Population (N=24)
Arm/Group Title CAM2038 q1w, 32 mg - Hydromorphone 6 Mg-Hydromorphone 0 mg CAM2038 q1w, 32 mg - Hydromorphone 18 mg- Hydromorphone 0mg CAM2038 q1w, 32 mg - Hydromorphone 18 mg- Hydromorphone 6 mg
Hide Arm/Group Description:
CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) and 6 mg intramuscular injection will be administered on 2 of the 3 days during baseline and 4 challenge sessions on Days -3--1,1-3, 4-6, 8-10 and 11-13.
CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg and Hydromorphone 0 mg intramuscular injection will be administered on 2 of the 3 days during baseline and4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg and Hydromorphone 6 mg intramuscular injection will be administered on 2 of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
Overall Number of Participants Analyzed 24 24 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Qualification/Baseline 26.7  (2.40) 40.3  (2.40) 13.7  (2.40)
Days 1-3 0.9  (1.05) 2.4  (1.05) 1.5  (1.05)
Days 4-6 1.5  (1.05) 4.5  (1.05) 3.0  (1.05)
Days 8 -10 0.5  (1.05) 2.5  (1.05) 2.0  (1.05)
Days 11-13 1.0  (1.05) 3.6  (1.05) 2.6  (1.05)
5.Secondary Outcome
Title Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Completer Population
Arm/Group Title CAM2038 q1w, 24 mg CAM2038 q1w, 32 mg
Hide Arm/Group Description:
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7.
CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7.
Overall Number of Participants Analyzed 22 24
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Baseline HMO 6mg-HMO 0mg
62.4
(53.7 to 71.2)
47.3
(35.8 to 58.7)
Baseline HMO18mg-HMO 0 mg
84.6
(75.8 to 93.3)
77.0
(65.5 to 88.4)
Baseline HMO 18mg - HMO 6mg
22.2
(13.4 to 30.9)
29.7
(18.3 to 41.2)
Challenge Session 1 HMO 6mg - HMO 0mg
4.3
(-0.4 to 9.0)
3.1
(-0.4 to 6.6)
Challenge Session 1 HMO 18mg - HMO 0mg
3.6
(-1.1 to 8.3)
3.2
(-0.3 to 6.7)
Challenge Session 1 HMO 18mg-HMO 6mg
-0.8
(-5.4 to 3.9)
0.1
(-3.4 to 3.6)
Challenge Session 2 HMO 6mg - HMO 0mg
1.8
(-2.9 to 6.5)
1.5
(-2.0 to 5.1)
Challenge Session 2 HMO 18mg - HMO 0mg
15.3
(10.6 to 20.0)
6.5
(3.0 to 10.1)
Challenge Session 2 HMO 18mg - HMO 6mg
13.5
(8.8 to 18.2)
5.0
(1.5 to 8.6)
Challenge Session 3 HMO6mg - HMO 0mg
2.6
(-2.1 to 7.2)
0.9
(-2.6 to 4.5)
Challenge Session 3 HMO 18mg - HMO 0mg
3.9
(-0.8 to 8.5)
5.4
(1.9 to 9.0)
Challenge Session 3 HMO 18mg - HMO 6mg
1.3
(-3.4 to 6.0)
4.5
(1.0 to 8.1)
Challenge Session 4 HMO 6mg - HMO 0mg
2.1
(-2.6 to 6.8)
1.3
(-2.2 to 4.8)
Challenge Session 4 HMO 18mg - HMO 0mg
6.4
(1.7 to 11.0)
6.0
(2.4 to 9.5)
Challenge Session 4 HMO 18mg - HMO 6mg
4.2
(-0.4 to 8.9)
4.7
(1.1 to 8.2)
6.Secondary Outcome
Title Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Completer Population
Arm/Group Title CAM2038 q1w, 24 mg CAM2038 q1w, 32 mg
Hide Arm/Group Description:
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7.
CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7.
Overall Number of Participants Analyzed 22 24
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Baseline HMO 6mg-HMO 0mg
61.6
(52.5 to 70.7)
52.8
(43.3 to 62.3)
Baseline HMO 18mg-HMO 0mg
85.4
(76.4 to 94.5)
81.8
(72.3 to 91.4)
Baseline HMO18mg-HMO 6mg
23.9
(14.8 to 32.9)
29.1
(19.6 to 38.6)
Challenge Session 1 HMO 6mg - HMO 0mg
0.8
(-5.1 to 6.6)
2.8
(-1.1 to 6.7)
Challenge Session 1 HMO 18mg - HMO 0mg
1.3
(-4.5 to 7.2)
4.9
(1.0 to 8.8)
Challenge Session 1 HMO 18mg-HMO 6mg
0.6
(-5.3 to 6.4)
2.1
(-1.8 to 6.0)
Challenge Session 2 HMO 6mg - HMO 0mg
1.8
(-4.0 to 7.7)
1.7
(-2.2 to 5.6)
Challenge Session 2 HMO 18mg - HMO 0mg
15.8
(10.0 to 21.7)
7.3
(3.4 to 11.2)
Challenge Session 2 HMO18mg - HMO 6mg
14.0
(8.1 to 19.8)
5.6
(1.7 to 9.5)
Challenge Session 3 HMO6mg - HMO 0mg
2.4
(-3.4 to 8.2)
0.8
(-3.1 to 4.7)
Challenge Session 3 HMO 18mg - HMO 0mg
4.7
(-1.2 to 10.5)
4.9
(1.0 to 8.9)
Challenge Session 3 HMO 18mg - HMO 6mg
2.3
(-3.5 to 8.1)
4.1
(0.2 to 8.1)
Challenge Session 3 HMO 6mg - HMO 0mg
2.2
(-3.6 to 8.0)
0.7
(-3.2 to 4.7)
Challenge Session 4 HMO 18mg - HMO 0mg
7.1
(1.3 to 13.0)
6.0
(2.1 to 9.9)
Challenge Session 4 HMO 18mg - HMO 6mg
4.9
(-0.9 to 10.8)
5.2
(1.3 to 9.2)
7.Secondary Outcome
Title Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w Group (Completer Population)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Completer Population
Arm/Group Title CAM2038 q1w, 24 mg - Hydromorphone 0 mg CAM2038 q1w, 24 mg - Hydromorphone 6 mg CAM2038 q1w, 24 mg - Hydromorphone 18 mg
Hide Arm/Group Description:
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0mg (placebo) intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 6 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
Overall Number of Participants Analyzed 22 22 22
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 3.0  (3.18) 8.4  (3.18) 13.1  (3.18)
Challenge Session 1 (Days 1-3) 5.0  (1.17) 0.9  (1.17) 0.8  (1.17)
Challenge Session 2 (Days 4-6) 1.5  (1.17) 0.8  (1.17) 1.6  (1.17)
Challenge Session 3 (Days 8-10) 0.8  (1.17) 0.7  (1.17) 1.6  (1.17)
Challenge Session 4 (Days 11-13) 1.0  (1.17) 1.0  (1.17) 0.9  (1.17)
8.Secondary Outcome
Title Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w Group (Completer Population)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Completer Population
Arm/Group Title CAM2038 q1w, 32 mg - Hydromorphone 0 mg CAM2038 q1w, 32 mg - Hydromorphone 6 mg CAM2038 q1w, 32 mg - Hydromorphone 18 mg
Hide Arm/Group Description:
CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo) intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 6 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 18 mg intramuscular injection will be administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
Overall Number of Participants Analyzed 24 24 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 5.9  (3.47) 13.1  (3.47) 12.6  (3.47)
Challenge Session 1 (Days 1-3) 1.2  (0.67) 1.3  (0.67) 1.4  (0.67)
Challenge Session 2 (Days 4-6) 0.5  (0.67) 1.4  (0.67) 2.1  (0.67)
Challenge Session 3 (Days 8-10) 0.6  (0.67) 0.8  (0.67) 2.8  (0.67)
Challenge Session 4 (Days 11-13) 0.6  (0.67) 1.0  (0.67) 1.3  (0.67)
9.Secondary Outcome
Title Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
(Completer Population)
Arm/Group Title CAM2038 q1w, 24 mg CAM2038 q1w, 32 mg
Hide Arm/Group Description:
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7.
CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7.
Overall Number of Participants Analyzed 22 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline HMO 6mg-HMO 0mg -18.0  (4.50) 14.1  (3.76)
Baseline HMO 18mg-HMO 0mg -31.0  (4.50) -29.2  (3.75)
Baseline HMO18mg-HMO 6mg 013.0  (4.50) -15.1  (3.75)
Challenge Session 1 HMO 6mg - HMO 0mg -0.2  (4.03) 8.7  (5.09)
Challenge Session 1 HMO 18mg - HMO 0mg 1.8  (4.03) -5.7  (5.08)
Challenge Session 1 HMO 18mg-HMO 6mg 2.0  (4.03) -14.4  (5.08)
Challenge Session 2 HMO 6mg - HMO 0mg -3.8  (4.03) -3.1  (5.09)
Challenge Session 2 HMO 18mg - HMO 0mg -6.2  (4.03) 0.7  (5.08)
Challenge Session 2 HMO 18mg - HMO 6mg -2.4  (4.03) 3.7  (5.08)
Challenge Session 3 HMO6mg - HMO 0mg -2.8  (4.03) 2.2  (5.09)
Challenge Session 3 HMO 18mg - HMO 0mg -1.8  (4.03) 0.4  (5.08)
Challenge Session 3 HMO 18mg - HMO 6mg 1.0  (4.03) -1.8  (5.08)
Challenge Session 4 HMO 6mg - HMO 0mg -2.2  (4.03) -0.2  (5.09)
Challenge Session 4 HMO 18mg - HMO 0mg -4.5  (4.03) 0.9  (5.08)
Challenge Session 4 HMO 18mg - HMO 6mg -2.3  (4.03) 1.1  (5.08)
10.Secondary Outcome
Title Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Hide Description 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
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Hide Analysis Population Description
(Completer Population)
Arm/Group Title CAM2038 q1w, 24 mg CAM2038 q1w, 32 mg
Hide Arm/Group Description:
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7.
CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7.
Overall Number of Participants Analyzed 22 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline HMO 6mg-HMO 0mg -18.0  (4.5) -14.1  (3.76)
Baseline HMO 18mg-HMO 0mg -31.0  (4.50) -29.2  (3.75)
Baseline HMO18mg-HMO 6mg -13.0  (4.50) -15.1  (3.75)
Challenge Session 1 HMO 6mg - HMO 0mg -2.2  (3.89) 1.7  (3.05)
Challenge Session 1 HMO 18mg - HMO 0mg -4.9  (3.89) -0.8  (3.05)
Challenge Session 1 HMO 18mg-HMO 6mg -2.8  (3.89) -2.5  (3.05)
Challenge Session 2 HMO 6mg - HMO 0mg -6.2  (3.89) -2.0  (3.05)
Challenge Session 2 HMO 18mg - HMO 0mg -8.3  (3.89) -2.7  (3.05)
Challenge Session 2 HMO 18mg - HMO 6mg -2.1  (3.89) -0.7  (3.05)
Challenge Session 3 HMO6mg - HMO 0mg -0.2  (3.89) -0.9  (3.05)
Challenge Session 3 HMO 18mg - HMO 0mg -7.5  (3.89) -4.3  (3.05)
Challenge Session 3 HMO 18mg - HMO 6mg -7.4  (3.89) -3.4  (3.05)
Challenge Session 4 HMO 6mg - HMO 0mg 0.7  (3.89) 1.8  (3.05)
Challenge Session 4 HMO 18mg - HMO 0mg -2.1  (3.89) -0.2  (3.05)
Challenge Session 4 HMO 18mg - HMO 6mg -2.8  (3.89) -2.0  (3.05)
11.Secondary Outcome
Title Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
(Completer Population)
Arm/Group Title CAM2038 q1w, 24 mg CAM2038 q1w, 32 mg
Hide Arm/Group Description:
CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7.
CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7.
Overall Number of Participants Analyzed 22 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline HMO 6mg-HMO 0mg 63.2  (4.49) 47.8  (5.25)
Baseline HMO 18mg-HMO 0mg 83.9  (4.49) 76.4  (5.24)
Baseline HMO18mg-HMO 6mg 20.7  (4.49) 28.6  (5.24)
Challenge Session 1 HMO 6mg - HMO 0mg 4.0  (2.27) 3.2  (2.36)
Challenge Session 1 HMO 18mg - HMO 0mg 3.5  (2.27) 6.8  (2.35)
Challenge Session 1 HMO 18mg-HMO 6mg -0.5  (2.27) 3.6  (2.35)
Challenge Session 2 HMO 6mg - HMO 0mg 1.6  (2.27) 3.6  (2.36)
Challenge Session 2 HMO 18mg - HMO 0mg 13.6  (2.27) 5.9  (2.35)
Challenge Session 2 HMO 18mg - HMO 6mg 11.9  (2.27) 2.2  (2.35)
Challenge Session 3 HMO6mg - HMO 0mg 2.4  (2.27) -1.1  (2.36)
Challenge Session 3 HMO 18mg - HMO 0mg 4.6  (2.27) 3.3  (2.35)
Challenge Session 3 HMO 18mg - HMO 6mg 2.2  (2.27) 4.4  (2.35)
Challenge Session 4 HMO 6mg - HMO 0mg 1.5  (2.27) -1.1  (2.36)
Challenge Session 4 HMO 18mg - HMO 0mg 6.9  (2.27) 2.1  (2.35)
Challenge Session 4 HMO 18mg - HMO 6mg 5.4  (2.27) 3.2  (2.35)
Time Frame All AEs were documented and followed from the time the patient had signed the informed consent form until 14 days after the Follow-up Visit (or 30 days after Early Termination). The maximum number of days being 61 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CAM2038 q1w, 24 mg CAM2038 q1w, 32 mg
Hide Arm/Group Description CAM2038 q1w 24 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg, and 18 mg intramuscular injections each being administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13. CAM2038 q1w 32 mg will be administered by subcutaneous injection on Day 0 and Day 7. Hydromorphone 0 mg (placebo), 6 mg, and 18 mg intramuscular injections each being administered on one day of the 3 days during baseline and 4 challenge sessions on Days -3--1, 1-3, 4-6, 8-10 and 11-13.
All-Cause Mortality
CAM2038 q1w, 24 mg CAM2038 q1w, 32 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/25 (0.00%) 
Hide Serious Adverse Events
CAM2038 q1w, 24 mg CAM2038 q1w, 32 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/25 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CAM2038 q1w, 24 mg CAM2038 q1w, 32 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   13/22 (59.09%)   24/25 (96.00%) 
Cardiac disorders     
Ventricular Tachycardia *  0/22 (0.00%)  2/25 (8.00%) 
Gastrointestinal disorders     
Constipation *  3/22 (13.64%)  6/25 (24.00%) 
Nausea *  1/22 (4.55%)  3/25 (12.00%) 
Faeces Hard *  0/22 (0.00%)  2/25 (8.00%) 
General disorders     
Injection Site Pain *  2/22 (9.09%)  3/25 (12.00%) 
Injection Site Erythema *  2/22 (9.09%)  2/25 (8.00%) 
Injection Site Pruritus *  1/22 (4.55%)  2/25 (8.00%) 
Injection site Haemorrhage *  0/22 (0.00%)  2/25 (8.00%) 
Nervous system disorders     
Headache *  3/22 (13.64%)  1/25 (4.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis Contac *  1/22 (4.55%)  2/25 (8.00%) 
Acne *  0/22 (0.00%)  2/25 (8.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sonnie Kim
Organization: Braeburn
Phone: 1 610 467 8717
EMail: sonnie@braeburnrx.com
Layout table for additonal information
Responsible Party: Braeburn Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02611752    
Other Study ID Numbers: HS-13-478
First Submitted: November 18, 2015
First Posted: November 23, 2015
Results First Submitted: August 3, 2018
Results First Posted: November 14, 2019
Last Update Posted: November 14, 2019