Trial Outcomes & Findings for Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence (NCT NCT02651584)
NCT ID: NCT02651584
Last Updated: 2019-08-22
Results Overview
Response Rate, denoted by response rate (Weeks 1-24). A responder is defined as a subject with at least 33% of urine toxicology results collected during the Phase 1 (4 out of 12 urine samples) and 67% of urine toxicology results collected during Phase 2 (4 out of 6 urine samples) being negative for illicit opioids and self - reported illicit opioid use.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
428 participants
Primary outcome timeframe
24 weeks
Results posted on
2019-08-22
Participant Flow
Participant milestones
| Measure |
Group 1: SL BPN Tablets + Placebo Subcutaneous (SC) Injections
SL BPN: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day.
CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Group 2: CAM2038 SC Injections + SL Placebo Tablets
CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection).
CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection).
SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily
|
|---|---|---|
|
Overall Study
STARTED
|
215
|
213
|
|
Overall Study
COMPLETED
|
126
|
121
|
|
Overall Study
NOT COMPLETED
|
89
|
92
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence
Baseline characteristics by cohort
| Measure |
Group 1: SL BP/NX Tablets + Placebo SC Injections
n=215 Participants
SL BPN/NX: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day.
CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Group 2: CAM2038 SC Injections + SL Placebo Tablets
n=213 Participants
CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection).
CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection).
SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily
|
Total
n=428 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 10.89 • n=93 Participants
|
38.7 years
STANDARD_DEVIATION 11.17 • n=4 Participants
|
38.4 years
STANDARD_DEVIATION 11.02 • n=27 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=93 Participants
|
92 Participants
n=4 Participants
|
165 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
142 Participants
n=93 Participants
|
121 Participants
n=4 Participants
|
263 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
48 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
95 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
164 Participants
n=93 Participants
|
159 Participants
n=4 Participants
|
323 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic or Latino
|
24 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Not Hispanic or Latino
|
191 Participants
n=93 Participants
|
188 Participants
n=4 Participants
|
379 Participants
n=27 Participants
|
|
BMI
|
26.2 kg/m^2
STANDARD_DEVIATION 5.55 • n=93 Participants
|
25.6 kg/m^2
STANDARD_DEVIATION 5.03 • n=4 Participants
|
25.9 kg/m^2
STANDARD_DEVIATION 5.30 • n=27 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Includes all subjects who were randomized and receiving at least one dose of study drug.
Response Rate, denoted by response rate (Weeks 1-24). A responder is defined as a subject with at least 33% of urine toxicology results collected during the Phase 1 (4 out of 12 urine samples) and 67% of urine toxicology results collected during Phase 2 (4 out of 6 urine samples) being negative for illicit opioids and self - reported illicit opioid use.
Outcome measures
| Measure |
Group 1: SL BP/NX Tablets + Placebo SC Injections
n=215 Participants
SL BPN/NX: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day.
CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Group 2: CAM2038 SC Injections + SL Placebo Tablets
n=213 Participants
CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection).
CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection).
SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily
|
|---|---|---|
|
Response Rate, Denoted by Response Rate (Weeks 1-24).
Responder
|
31 Participants
|
37 Participants
|
|
Response Rate, Denoted by Response Rate (Weeks 1-24).
Non-Responder
|
184 Participants
|
176 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Includes all subjects who were randomized and receiving at least one dose of study drug.
Cumulative distribution function (CDF) of percentage of urine samples negative for illicit opioids comparing CAM2038 to SL BPN/NX as (supported by self-reported opioid use results)
Outcome measures
| Measure |
Group 1: SL BP/NX Tablets + Placebo SC Injections
n=215 Participants
SL BPN/NX: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day.
CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Group 2: CAM2038 SC Injections + SL Placebo Tablets
n=213 Participants
CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection).
CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection).
SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily
|
|---|---|---|
|
Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids
With Subjects' Self Reported Opioid Use
|
0.0 percentage of negative urine samples
Interval 0.0 to 100.0
|
26.7 percentage of negative urine samples
Interval 0.0 to 100.0
|
|
Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids
Without Subjects' Self reported Opioid Use
|
6.7 percentage of negative urine samples
Interval 0.0 to 100.0
|
26.7 percentage of negative urine samples
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 24 weeksNumber of Subjects with Sustained Abstinence of Opioid Use taking SL BPN/NX and CAM2038
Outcome measures
| Measure |
Group 1: SL BP/NX Tablets + Placebo SC Injections
n=215 Participants
SL BPN/NX: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day.
CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Group 2: CAM2038 SC Injections + SL Placebo Tablets
n=213 Participants
CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection).
CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection).
SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily
|
|---|---|---|
|
Number of Subjects With Sustained Abstinence of Opioid Use
Subjects with sustained abstinence of opioids
|
30 Participants
|
39 Participants
|
|
Number of Subjects With Sustained Abstinence of Opioid Use
Subjects without sustained abstinence of opioids
|
185 Participants
|
174 Participants
|
SECONDARY outcome
Timeframe: 24 weeksNumber of Subjects Remaining in the Study (Retention Rate) on SL BPN/NX and CAM2038
Outcome measures
| Measure |
Group 1: SL BP/NX Tablets + Placebo SC Injections
n=215 Participants
SL BPN/NX: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day.
CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Group 2: CAM2038 SC Injections + SL Placebo Tablets
n=213 Participants
CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection).
CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection).
SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily
|
|---|---|---|
|
Number of Subjects Remaining in the Study (Retention Rate)
Retained
|
126 Participants
|
121 Participants
|
|
Number of Subjects Remaining in the Study (Retention Rate)
Not Retained
|
89 Participants
|
92 Participants
|
Adverse Events
Group 1: SL BPN/NX Tablets + Placebo SC Injections
Serious events: 16 serious events
Other events: 119 other events
Deaths: 0 deaths
Group 2: CAM2038 SC Injections + SL Placebo Tablets
Serious events: 5 serious events
Other events: 128 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group 1: SL BPN/NX Tablets + Placebo SC Injections
n=215 participants at risk
SL BPN: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day.
CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Group 2: CAM2038 SC Injections + SL Placebo Tablets
n=213 participants at risk
CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection).
CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection).
SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily
|
|---|---|---|
|
Infections and infestations
Abscess limb
|
0.47%
1/215 • Number of events 1 • 31 weeks
|
0.00%
0/213 • 31 weeks
|
|
Infections and infestations
Acute Hepatitis C
|
0.47%
1/215 • Number of events 1 • 31 weeks
|
0.00%
0/213 • 31 weeks
|
|
Infections and infestations
Cellulitis
|
0.47%
1/215 • Number of events 1 • 31 weeks
|
0.00%
0/213 • 31 weeks
|
|
Infections and infestations
Osteomyelitis
|
0.47%
1/215 • Number of events 1 • 31 weeks
|
0.00%
0/213 • 31 weeks
|
|
Infections and infestations
Pneumonia
|
0.47%
1/215 • Number of events 1 • 31 weeks
|
0.00%
0/213 • 31 weeks
|
|
Infections and infestations
Sepsis
|
0.47%
1/215 • Number of events 1 • 31 weeks
|
0.00%
0/213 • 31 weeks
|
|
Infections and infestations
Localized infection
|
0.47%
1/215 • Number of events 1 • 31 weeks
|
0.00%
0/213 • 31 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
0.47%
1/215 • Number of events 1 • 31 weeks
|
0.00%
0/213 • 31 weeks
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
1.4%
3/215 • Number of events 3 • 31 weeks
|
0.00%
0/213 • 31 weeks
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.47%
1/215 • Number of events 1 • 31 weeks
|
0.00%
0/213 • 31 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/215 • 31 weeks
|
0.47%
1/213 • Number of events 1 • 31 weeks
|
|
Psychiatric disorders
Bipolar disorder
|
0.47%
1/215 • Number of events 1 • 31 weeks
|
0.00%
0/213 • 31 weeks
|
|
Psychiatric disorders
Substance-induce mood disorder
|
0.47%
1/215 • Number of events 1 • 31 weeks
|
0.00%
0/213 • 31 weeks
|
|
Psychiatric disorders
Suicidal Ideation
|
0.47%
1/215 • Number of events 1 • 31 weeks
|
0.47%
1/213 • Number of events 1 • 31 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/215 • 31 weeks
|
0.47%
1/213 • Number of events 1 • 31 weeks
|
|
General disorders
Non-cardiac Chest Pain
|
0.00%
0/215 • 31 weeks
|
0.47%
1/213 • Number of events 1 • 31 weeks
|
|
Nervous system disorders
Seizure
|
0.47%
1/215 • Number of events 1 • 31 weeks
|
0.00%
0/213 • 31 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/215 • 31 weeks
|
0.47%
1/213 • Number of events 1 • 31 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disorder
|
0.47%
1/215 • Number of events 1 • 31 weeks
|
0.00%
0/213 • 31 weeks
|
|
Congenital, familial and genetic disorders
Haemophilia
|
0.47%
1/215 • Number of events 1 • 31 weeks
|
0.00%
0/213 • 31 weeks
|
Other adverse events
| Measure |
Group 1: SL BPN/NX Tablets + Placebo SC Injections
n=215 participants at risk
SL BPN: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day.
CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).
|
Group 2: CAM2038 SC Injections + SL Placebo Tablets
n=213 participants at risk
CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection).
CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection).
SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily
|
|---|---|---|
|
General disorders
Injection site pain
|
7.9%
17/215 • Number of events 17 • 31 weeks
|
8.9%
19/213 • Number of events 19 • 31 weeks
|
|
General disorders
Injection site pruritus
|
6.0%
13/215 • Number of events 13 • 31 weeks
|
6.1%
13/213 • Number of events 13 • 31 weeks
|
|
General disorders
Injection site erythema
|
5.6%
12/215 • Number of events 12 • 31 weeks
|
5.6%
12/213 • Number of events 12 • 31 weeks
|
|
General disorders
Injection site reaction
|
3.3%
7/215 • Number of events 7 • 31 weeks
|
3.8%
8/213 • Number of events 8 • 31 weeks
|
|
General disorders
Injection site swelling
|
2.8%
6/215 • Number of events 6 • 31 weeks
|
4.2%
9/213 • Number of events 9 • 31 weeks
|
|
General disorders
Injection site induration
|
2.8%
6/215 • Number of events 6 • 31 weeks
|
1.9%
4/213 • Number of events 4 • 31 weeks
|
|
General disorders
Injection site inflammation
|
3.7%
8/215 • Number of events 8 • 31 weeks
|
0.94%
2/213 • Number of events 2 • 31 weeks
|
|
Infections and infestations
Urinary tract infection
|
4.7%
10/215 • Number of events 10 • 31 weeks
|
5.2%
11/213 • Number of events 11 • 31 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
4.2%
9/215 • Number of events 9 • 31 weeks
|
4.2%
9/213 • Number of events 9 • 31 weeks
|
|
Infections and infestations
Cellulitis
|
3.3%
7/215 • Number of events 7 • 31 weeks
|
0.47%
1/213 • Number of events 1 • 31 weeks
|
|
Gastrointestinal disorders
Constipation
|
7.4%
16/215 • Number of events 16 • 31 weeks
|
7.5%
16/213 • Number of events 16 • 31 weeks
|
|
Gastrointestinal disorders
Nausea
|
7.9%
17/215 • Number of events 17 • 31 weeks
|
7.0%
15/213 • Number of events 15 • 31 weeks
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
8/215 • Number of events 8 • 31 weeks
|
4.2%
9/213 • Number of events 9 • 31 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
7/215 • Number of events 7 • 31 weeks
|
2.8%
6/213 • Number of events 6 • 31 weeks
|
|
Gastrointestinal disorders
Toothache
|
3.7%
8/215 • Number of events 8 • 31 weeks
|
1.4%
3/213 • Number of events 3 • 31 weeks
|
|
Nervous system disorders
Headache
|
7.9%
17/215 • Number of events 17 • 31 weeks
|
7.5%
16/213 • Number of events 16 • 31 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
3/215 • Number of events 3 • 31 weeks
|
3.3%
7/213 • Number of events 7 • 31 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.8%
6/215 • Number of events 6 • 31 weeks
|
1.4%
3/213 • Number of events 3 • 31 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
2.3%
5/215 • Number of events 5 • 31 weeks
|
0.00%
0/213 • 31 weeks
|
|
Psychiatric disorders
Insomnia
|
2.8%
6/215 • Number of events 6 • 31 weeks
|
5.6%
12/213 • Number of events 12 • 31 weeks
|
|
Psychiatric disorders
Anxiety
|
3.3%
7/215 • Number of events 7 • 31 weeks
|
2.8%
6/213 • Number of events 6 • 31 weeks
|
|
Cardiac disorders
Tachycardia
|
2.3%
5/215 • Number of events 5 • 31 weeks
|
2.3%
5/213 • Number of events 5 • 31 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place