Trial Outcomes & Findings for Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder (NCT NCT02672111)

NCT ID: NCT02672111

Last Updated: 2020-05-15

Results Overview

Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Overall Safety Population

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 228 participants
• Primary outcome timeframe: 12 months- 48 week
• Results posted on: 2020-05-15

Participant Flow

One patient enrolled in the study but did not receive CAM2038

Participant milestones

Measure	CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX Subjects previously exposed to SL BPN/NX who received CAM2038 q1w or q4w	CAM2038 q1w or q4w New to BPN Treatment New to BPN Treatment who received CAM2038 q1w or q4w
Overall Study STARTED	190	37
Overall Study Completed Treatment	138	29
Overall Study COMPLETED	132	25
Overall Study NOT COMPLETED	58	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder

Baseline characteristics by cohort

Measure	CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX n=190 Participants Subjects previously exposed to SL BPN/NX who received CAM2038 q1w or q4w	CAM2038 q1w or q4w New to BPN Treatment n=37 Participants New to BPN Treatment who received CAM2028 q1w or q4w	Total n=227 Participants Total of all reporting groups
Age, Continuous	41.3 years n=5 Participants	41.8 years n=7 Participants	41.4 years n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	13 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	119 Participants n=5 Participants	24 Participants n=7 Participants	143 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	187 Participants n=5 Participants	35 Participants n=7 Participants	222 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	17 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	183 Participants n=5 Participants	20 Participants n=7 Participants	203 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	91 Participants n=5 Participants	36 Participants n=7 Participants	127 Participants n=5 Participants
Region of Enrollment Europe	76 Participants n=5 Participants	0 Participants n=7 Participants	76 Participants n=5 Participants
Region of Enrollment Australia	23 Participants n=5 Participants	1 Participants n=7 Participants	24 Participants n=5 Participants
BMI (kg/m^2)	26.7 kg/m^2 n=5 Participants	25.3 kg/m^2 n=7 Participants	26.5 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: 12 months- 48 week

Population: Overall Safety Population-Subjects treated with CAM2038

Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Overall Safety Population

Outcome measures

Measure	CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX n=190 Participants Subjects previously exposed to SL BPN/NX who received CAM2038 q1w or q4w	CAM2038 q1w or q4w New to BPN Treatment n=37 Participants New to BPN Treatment who received CAM2038 q1w or q4w
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population Subject had at least 1 TEAE	131 participants	12 participants
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population Subject had at least 1 drug-related TEAE	58 participants	2 participants
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population Subject had at least 1 severe TEAE	13 participants	2 participants
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population Deaths	0 participants	0 participants
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population Subject had at least 1 non-fatal SAE	10 participants	2 participants
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population Subject had at least 1 non-fatal drug related SAE	0 participants	0 participants
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population Hospitalizations	9 participants	1 participants
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population Subject discontinued study drug due to a TEAE	4 participants	1 participants

PRIMARY outcome

Timeframe: 12 months- 48 week

Population: Full Exposure Safety Population-Subjects treated with CAM2038

Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Full Exposure Safety Population

Outcome measures

Measure	CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX n=128 Participants Subjects previously exposed to SL BPN/NX who received CAM2038 q1w or q4w	CAM2038 q1w or q4w New to BPN Treatment n=28 Participants New to BPN Treatment who received CAM2038 q1w or q4w
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population Subject had at least 1 TEAE	95 participants	8 participants
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population Subject had at least 1 drug-related TEAE	41 participants	1 participants
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population Subject had at least 1 severe TEAE	11 participants	1 participants
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population Deaths	0 participants	0 participants
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population Subject had at least 1 non-fatal SAE	8 participants	1 participants
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population Subject had at least 1 non-fatal drug related SAE	0 participants	0 participants
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population Hospitalizations	7 participants	1 participants
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population Subject discontinued study drug due to a TEAE	0 participants	0 participants

SECONDARY outcome

Timeframe: 12 months (48 weeks)

Population: Efficacy Population

The following is a summary of Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population)

Outcome measures

Measure	CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX n=189 Participants Subjects previously exposed to SL BPN/NX who received CAM2038 q1w or q4w	CAM2038 q1w or q4w New to BPN Treatment n=37 Participants New to BPN Treatment who received CAM2038 q1w or q4w
Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population)	82.8 percentage of negative urine samples Standard Deviation 29.31	41.2 percentage of negative urine samples Standard Deviation 34.04

SECONDARY outcome

Timeframe: 12 months (48 weeks)

Population: Efficacy Population

The following is a summary of Mean Percentage of Self-Reported No Illicit Opioid Use during the entire study (Efficacy Population). The proportion of patients who reported no illicit opioid use during the study was analyzed. For example if a subject provided 10 self reports and 2 out of the 10 were "Used", the percentage for the subject would be 20%. The average percentage of all patients is provided.

Outcome measures

Measure	CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX n=188 Participants Subjects previously exposed to SL BPN/NX who received CAM2038 q1w or q4w	CAM2038 q1w or q4w New to BPN Treatment n=37 Participants New to BPN Treatment who received CAM2038 q1w or q4w
Mean Percentage of Self-reported No Illicit Opioid Use (Efficacy Population)	92.5 Mean percentage of no illicit opioid use Standard Deviation 19.78	74.0 Mean percentage of no illicit opioid use Standard Deviation 31.28

SECONDARY outcome

Timeframe: 48 weeks of treatment

Population: Efficacy Population

The following is a summary of treatment retention over 48 weeks

Outcome measures

Measure	CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX n=190 Participants Subjects previously exposed to SL BPN/NX who received CAM2038 q1w or q4w	CAM2038 q1w or q4w New to BPN Treatment n=37 Participants New to BPN Treatment who received CAM2038 q1w or q4w
Summary of Retention in Treatment (Efficacy Population)	38.3 weeks Standard Deviation 16.85	43.6 weeks Standard Deviation 11.50

SECONDARY outcome

Timeframe: 12 months- 48 week

Population: Efficacy Population

A summary of COWS (administered by the Clinician) over 48 weeks to show withdrawal symptoms from baseline to end of treatment. This scale consists of 11 common opiate withdrawal signs or symptoms, rated on a numeric scale from 0 to 4 or 5 and based on a timed period of observation of the subject by the rater. Higher scores are associated with greater withdrawal symptoms with a total range for all items of between 0-48

Outcome measures

Measure	CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX n=190 Participants Subjects previously exposed to SL BPN/NX who received CAM2038 q1w or q4w	CAM2038 q1w or q4w New to BPN Treatment n=37 Participants New to BPN Treatment who received CAM2038 q1w or q4w
Summary of Clinical Opiate Withdrawal Scale (COWS) at Selected Time Points (Efficacy Population) Baseline	2.0 score on a scale Standard Deviation 2.7	10.6 score on a scale Standard Deviation 3.7
Summary of Clinical Opiate Withdrawal Scale (COWS) at Selected Time Points (Efficacy Population) Visit 3 Day 8	3.7 score on a scale Standard Deviation 4.1	3.0 score on a scale Standard Deviation 2.5
Summary of Clinical Opiate Withdrawal Scale (COWS) at Selected Time Points (Efficacy Population) Visit 26 Day 169	1.9 score on a scale Standard Deviation 2.8	0.2 score on a scale Standard Deviation 0.4
Summary of Clinical Opiate Withdrawal Scale (COWS) at Selected Time Points (Efficacy Population) End of Treatment	1.4 score on a scale Standard Deviation 2.3	0.3 score on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 12 months- 48 week

Population: Efficacy Population

Summary of SOWS over time to show withdrawal symtons, from baseline to end of treatment. This form contains 16 questions that rate the intensity of withdrawal from 0 ("Not at all") to 4 ("Extremely"), with higher scores associated with greater withdrawal symptoms and total range for all items of 0-64

Outcome measures

Measure	CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX n=190 Participants Subjects previously exposed to SL BPN/NX who received CAM2038 q1w or q4w	CAM2038 q1w or q4w New to BPN Treatment n=37 Participants New to BPN Treatment who received CAM2038 q1w or q4w
Summary of Subjective Opiate Withdrawal Scale (SOWS) at Selected Time Points (Efficacy Population) Baseline	4.7 score on a scale Standard Deviation 8.1	27.1 score on a scale Standard Deviation 15.3
Summary of Subjective Opiate Withdrawal Scale (SOWS) at Selected Time Points (Efficacy Population) Visit 3 Day 8	8.4 score on a scale Standard Deviation 11.5	8.9 score on a scale Standard Deviation 10.9
Summary of Subjective Opiate Withdrawal Scale (SOWS) at Selected Time Points (Efficacy Population) Visit 26 Day 169	4.3 score on a scale Standard Deviation 7.2	3.0 score on a scale Standard Deviation 7.5
Summary of Subjective Opiate Withdrawal Scale (SOWS) at Selected Time Points (Efficacy Population) End of Treatment	3.3 score on a scale Standard Deviation 6.3	3.9 score on a scale Standard Deviation 8.0

SECONDARY outcome

Timeframe: 12 months- 48 week

Population: Efficacy Population

The following table summarizes the desire to use measurements over a period of 12 months - 48 weeks. Desire to Use assessments were administered using a unipolar 100 mm VAS. Subjects were asked "Since your last scheduled assessment visit, indicate your worst or strongest desire to use opioids, where 0 = No desire to use and 100 mm = Strongest possible desire.

Outcome measures

Measure	CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX n=190 Participants Subjects previously exposed to SL BPN/NX who received CAM2038 q1w or q4w	CAM2038 q1w or q4w New to BPN Treatment n=37 Participants New to BPN Treatment who received CAM2038 q1w or q4w
Summary of Desire to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population) Baseline	11.7 score on a scale Standard Deviation 24.2	74.8 score on a scale Standard Deviation 24.8
Summary of Desire to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population) Visit 3 Day 8	18.8 score on a scale Standard Deviation 29.8	23.0 score on a scale Standard Deviation 25.9
Summary of Desire to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population) Visit 26 Day 169	6.4 score on a scale Standard Deviation 15.6	5.8 score on a scale Standard Deviation 16.7
Summary of Desire to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population) End of Treatment	6.4 score on a scale Standard Deviation 16.5	2.8 score on a scale Standard Deviation 6.2

SECONDARY outcome

Timeframe: 12 months- 48 week

Population: Efficacy Population

The following results summarize the need to use VAS over a period of 12 months - 48 weeks. Need to Use assessments were administered using a unipolar 100 mm VAS. Subjects were asked "Since your last scheduled assessment visit, indicate your worst or strongest need to use opioids, where 0 = No need to use and 100 mm = Strongest possible need.

Outcome measures

Measure	CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX n=190 Participants Subjects previously exposed to SL BPN/NX who received CAM2038 q1w or q4w	CAM2038 q1w or q4w New to BPN Treatment n=37 Participants New to BPN Treatment who received CAM2038 q1w or q4w
Summary of Need to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population) Baseline	11.7 score on a scale Standard Deviation 23.8	76.3 score on a scale Standard Deviation 24.9
Summary of Need to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population) Visit 3 Day 8	18.0 score on a scale Standard Deviation 27.9	34.3 score on a scale Standard Deviation 29.2
Summary of Need to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population) Visit 26 Day 169	5.6 score on a scale Standard Deviation 12.5	8.0 score on a scale Standard Deviation 18.2
Summary of Need to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population) End of Treatment	5.4 score on a scale Standard Deviation 14.3	5.3 score on a scale Standard Deviation 15.9

Adverse Events

CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX

Serious events: 13 serious events

Other events: 131 other events

Deaths: 0 deaths

CAM2038 q1w or q4w New to BPN Treatment

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX n=190 participants at risk Subjects exposed to SL BPN/NX who received CAM2038 q1w or q4w	CAM2038 q1w or q4w New to BPN Treatment n=37 participants at risk New to BPN Treatment who received either CAM2028 q1w or q4w
Infections and infestations Cellulitis	0.53% 1/190 • Number of events 1 • Time frame of adverse events was 12 months - 48 weeks.	0.00% 0/37 • Time frame of adverse events was 12 months - 48 weeks.
Infections and infestations Pneumonia	0.00% 0/190 • Time frame of adverse events was 12 months - 48 weeks.	2.7% 1/37 • Number of events 1 • Time frame of adverse events was 12 months - 48 weeks.
Nervous system disorders Seizure	0.53% 1/190 • Number of events 1 • Time frame of adverse events was 12 months - 48 weeks.	2.7% 1/37 • Number of events 1 • Time frame of adverse events was 12 months - 48 weeks.
Gastrointestinal disorders Duodenitis	0.53% 1/190 • Number of events 1 • Time frame of adverse events was 12 months - 48 weeks.	0.00% 0/37 • Time frame of adverse events was 12 months - 48 weeks.
Cardiac disorders Ventricular tachycardia	0.53% 1/190 • Number of events 1 • Time frame of adverse events was 12 months - 48 weeks.	0.00% 0/37 • Time frame of adverse events was 12 months - 48 weeks.
Injury, poisoning and procedural complications Multiple injuries	0.53% 1/190 • Number of events 1 • Time frame of adverse events was 12 months - 48 weeks.	0.00% 0/37 • Time frame of adverse events was 12 months - 48 weeks.
Injury, poisoning and procedural complications Road traffic accident	0.53% 1/190 • Number of events 1 • Time frame of adverse events was 12 months - 48 weeks.	0.00% 0/37 • Time frame of adverse events was 12 months - 48 weeks.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.53% 1/190 • Number of events 1 • Time frame of adverse events was 12 months - 48 weeks.	0.00% 0/37 • Time frame of adverse events was 12 months - 48 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular thyroid cancer	0.53% 1/190 • Number of events 1 • Time frame of adverse events was 12 months - 48 weeks.	0.00% 0/37 • Time frame of adverse events was 12 months - 48 weeks.
Vascular disorders Peripheral vascular disorder	0.53% 1/190 • Number of events 1 • Time frame of adverse events was 12 months - 48 weeks.	0.00% 0/37 • Time frame of adverse events was 12 months - 48 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.53% 1/190 • Number of events 1 • Time frame of adverse events was 12 months - 48 weeks.	0.00% 0/37 • Time frame of adverse events was 12 months - 48 weeks.
Psychiatric disorders Psychotic Disorder	0.53% 1/190 • Number of events 1 • Time frame of adverse events was 12 months - 48 weeks.	0.00% 0/37 • Time frame of adverse events was 12 months - 48 weeks.
Psychiatric disorders Substance-induced psychotic disorder	0.53% 1/190 • Number of events 1 • Time frame of adverse events was 12 months - 48 weeks.	0.00% 0/37 • Time frame of adverse events was 12 months - 48 weeks.
General disorders Drug withdrawal syndrome	0.53% 1/190 • Number of events 1 • Time frame of adverse events was 12 months - 48 weeks.	0.00% 0/37 • Time frame of adverse events was 12 months - 48 weeks.
Hepatobiliary disorders Cholecystitis chronic	0.53% 1/190 • Number of events 1 • Time frame of adverse events was 12 months - 48 weeks.	0.00% 0/37 • Time frame of adverse events was 12 months - 48 weeks.

Other adverse events

Measure	CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX n=190 participants at risk Subjects exposed to SL BPN/NX who received CAM2038 q1w or q4w	CAM2038 q1w or q4w New to BPN Treatment n=37 participants at risk New to BPN Treatment who received either CAM2028 q1w or q4w
General disorders Injection site Pain	17.4% 33/190 • Number of events 33 • Time frame of adverse events was 12 months - 48 weeks.	5.4% 2/37 • Number of events 2 • Time frame of adverse events was 12 months - 48 weeks.
General disorders Injection SIte Swelling	13.2% 25/190 • Number of events 25 • Time frame of adverse events was 12 months - 48 weeks.	5.4% 2/37 • Number of events 2 • Time frame of adverse events was 12 months - 48 weeks.
General disorders Injection site erythema	10.5% 20/190 • Number of events 20 • Time frame of adverse events was 12 months - 48 weeks.	2.7% 1/37 • Number of events 1 • Time frame of adverse events was 12 months - 48 weeks.
Gastrointestinal disorders Nausea	8.4% 16/190 • Number of events 16 • Time frame of adverse events was 12 months - 48 weeks.	0.00% 0/37 • Time frame of adverse events was 12 months - 48 weeks.
Nervous system disorders Headache	9.5% 18/190 • Number of events 18 • Time frame of adverse events was 12 months - 48 weeks.	0.00% 0/37 • Time frame of adverse events was 12 months - 48 weeks.
Gastrointestinal disorders Vomiting	6.3% 12/190 • Number of events 12 • Time frame of adverse events was 12 months - 48 weeks.	0.00% 0/37 • Time frame of adverse events was 12 months - 48 weeks.
Infections and infestations Nasopharyngitis	8.9% 17/190 • Number of events 17 • Time frame of adverse events was 12 months - 48 weeks.	2.7% 1/37 • Number of events 1 • Time frame of adverse events was 12 months - 48 weeks.
Infections and infestations Urinary tract infection	4.7% 9/190 • Number of events 9 • Time frame of adverse events was 12 months - 48 weeks.	8.1% 3/37 • Number of events 3 • Time frame of adverse events was 12 months - 48 weeks.
Gastrointestinal disorders Diarrhoea	0.00% 0/190 • Time frame of adverse events was 12 months - 48 weeks.	5.4% 2/37 • Number of events 2 • Time frame of adverse events was 12 months - 48 weeks.

Additional Information

Sonnie Kim

Braeburn

Phone: 1 610 467 8717

Email: sonnie@braeburnrx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place