Trial Outcomes & Findings for Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone (NCT NCT00637000)
NCT ID: NCT00637000
Last Updated: 2017-06-05
Results Overview
The COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the response to each of the 11 items and cover a range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal. The baseline COWS was the score obtained 30 minutes prior to administration of soluble films on Day 1. Peak COWS was the highest COWS score obtained between 1-23.5 hours post administration on Day 1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1
Results posted on
2017-06-05
Participant Flow
Patient enrollment commenced 03/19/08 and was completed 09/19/08. The study site was an in-patient research-based clinic affiliated with Johns Hopkins University School of Medicine.
During screening run-in, subjects received 30 mg morphine subcutaneously up to 4 times/day for up to 13 days. Subjects underwent two test sessions, consisting of a challenge of naloxone (0.4 mg) or placebo intramuscularly and evaluation for the severity of withdrawal. Subjects able to detect withdrawal were randomized to treatment.
Participant milestones
| Measure |
Sublingual Buprenorphine Soluble Film
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine/Naloxone Soluble Film
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
18
|
|
Overall Study
Evaluable
|
18
|
16
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Sublingual Buprenorphine Soluble Film
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine/Naloxone Soluble Film
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
Baseline Characteristics
Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone
Baseline characteristics by cohort
| Measure |
Sublingual Buprenorphine Soluble Film
n=20 Participants
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine/Naloxone Soluble Film
n=18 Participants
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40.2 years
STANDARD_DEVIATION 10 • n=5 Participants
|
40.2 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
40.2 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
18 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1Population: Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.
The COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the response to each of the 11 items and cover a range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal. The baseline COWS was the score obtained 30 minutes prior to administration of soluble films on Day 1. Peak COWS was the highest COWS score obtained between 1-23.5 hours post administration on Day 1.
Outcome measures
| Measure |
Sublingual Buprenorphine/Naloxone Soluble Film
n=16 Participants
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine Soluble Film
n=18 Participants
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at Baseline and the Peak COWS up to 23.5 Hours After the First Administration
Baseline
|
10.1 units on a scale
Standard Deviation 6.4
|
9.1 units on a scale
Standard Deviation 5.5
|
|
Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at Baseline and the Peak COWS up to 23.5 Hours After the First Administration
Peak
|
5.7 units on a scale
Standard Deviation 3.2
|
4.2 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5Population: Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.
The COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the response to each of the 11 items and cover a range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal. The end of induction COWS was the score obtained 47.5 hours after first administration of soluble films on Day 1. Peak post induction COWS was the highest COWS score obtained on Days 2-5.
Outcome measures
| Measure |
Sublingual Buprenorphine/Naloxone Soluble Film
n=16 Participants
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine Soluble Film
n=18 Participants
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at the End of Induction and the Peak COWS Post Induction
End of Induction
|
1.0 units on a scale
Standard Deviation 1.0
|
0.6 units on a scale
Standard Deviation 0.5
|
|
Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at the End of Induction and the Peak COWS Post Induction
Peak Post Induction
|
2.6 units on a scale
Standard Deviation 2.4
|
1.0 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline: 15 minutes prior to first administration on Day 1. Peak: 15 minutes - 23.5 hours post administration on Day 1Population: Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.
Pupil diameter was measured at baseline and at intervals post drug administration on Day 1. Peak measurement is the maximum pupil diameter recorded from 15 minutes to 23.5 hours post administration of study intervention.
Outcome measures
| Measure |
Sublingual Buprenorphine/Naloxone Soluble Film
n=16 Participants
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine Soluble Film
n=18 Participants
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Pupil Diameter Measurements at Baseline and the Maximum Pupil Diameter up to 23.5 Hours After the First Administration
Baseline
|
6.11 mm
Standard Deviation 0.88
|
6.24 mm
Standard Deviation 0.97
|
|
Pupil Diameter Measurements at Baseline and the Maximum Pupil Diameter up to 23.5 Hours After the First Administration
Peak
|
5.99 mm
Standard Deviation 0.98
|
4.39 mm
Standard Deviation 6.27
|
SECONDARY outcome
Timeframe: Baseline: 15 minutes prior to first administration on Day 1. Peak: 15 minutes - 23.5 hours post administration on Day 1Population: Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.
Pupil diameter was measured at baseline and at intervals post drug administration on Day 1. Peak measurement is the minimum pupil diameter recorded from 15 minutes to 23.5 hours post administration of study intervention.
Outcome measures
| Measure |
Sublingual Buprenorphine/Naloxone Soluble Film
n=16 Participants
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine Soluble Film
n=18 Participants
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Pupil Diameter Measurements at Baseline and the Minimum Pupil Diameter up to 23.5 Hours After the First Administration
Baseline
|
6.11 mm
Standard Deviation 0.88
|
6.24 mm
Standard Deviation 0.97
|
|
Pupil Diameter Measurements at Baseline and the Minimum Pupil Diameter up to 23.5 Hours After the First Administration
Peak
|
4.32 mm
Standard Deviation 1.08
|
4.39 mm
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5Population: Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.
Pupil diameter was measured at the end of induction (47.5 hours after the first administration of study intervention) and at intervals during the post-induction period (Days 3-5). Peak post induction measurement is the minimum pupil diameter recorded during days 3-5.
Outcome measures
| Measure |
Sublingual Buprenorphine/Naloxone Soluble Film
n=16 Participants
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine Soluble Film
n=18 Participants
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Pupil Diameter Measurements At End of Induction (End of Day 2) and the Minimum Pupil Diameter During the Post Induction Period (Days 3-5)
End of Induction
|
5.1 mm
Standard Deviation 1.2
|
5.3 mm
Standard Deviation 1.2
|
|
Pupil Diameter Measurements At End of Induction (End of Day 2) and the Minimum Pupil Diameter During the Post Induction Period (Days 3-5)
Peak Post Induction
|
3.6 mm
Standard Deviation 0.9
|
4.1 mm
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1Population: Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.
A visual analog scale (VAS) was used by participants to answer the subjective question, "How high are you?". The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=not high and 100=extremely high. The baseline VAS was the score obtained 30 minutes prior to administration of soluble films on Day 1. Peak VAS was the highest VAS score obtained between 1-23.5 hours post administration on Day 1.
Outcome measures
| Measure |
Sublingual Buprenorphine/Naloxone Soluble Film
n=16 Participants
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine Soluble Film
n=18 Participants
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: "How High Are You?"
Baseline
|
0.0 units on a scale
Standard Deviation 0.3
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: "How High Are You?"
Peak
|
13.7 units on a scale
Standard Deviation 24.0
|
5.8 units on a scale
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1Population: Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.
A visual analog scale (VAS) was used by participants to answer the subjective question, "Do you feel any drug effect?". The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect.
Outcome measures
| Measure |
Sublingual Buprenorphine/Naloxone Soluble Film
n=16 Participants
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine Soluble Film
n=18 Participants
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: "Do You Feel Any Drug Effect?"
Baseline
|
0.0 units on a scale
Standard Deviation 0.0
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: "Do You Feel Any Drug Effect?"
Peak
|
50.4 units on a scale
Standard Deviation 26.0
|
44.3 units on a scale
Standard Deviation 31.5
|
SECONDARY outcome
Timeframe: Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1Population: Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.
A visual analog scale (VAS) was used by participants to answer the subjective question, "Do you feel any good effects?". The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no good effects and 100=maximum good effects.
Outcome measures
| Measure |
Sublingual Buprenorphine/Naloxone Soluble Film
n=16 Participants
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine Soluble Film
n=18 Participants
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: "Does the Drug Have Any Good Effects?"
Baseline
|
0.0 units on a scale
Standard Deviation 0.0
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: "Does the Drug Have Any Good Effects?"
Peak
|
57.6 units on a scale
Standard Deviation 31.4
|
62.3 units on a scale
Standard Deviation 35.1
|
SECONDARY outcome
Timeframe: Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1Population: Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.
A visual analog scale (VAS) was used by participants to answer the subjective question, "Does the drug have any bad effects?". The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no bad effects and 100=maximum bad effects.
Outcome measures
| Measure |
Sublingual Buprenorphine/Naloxone Soluble Film
n=16 Participants
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine Soluble Film
n=18 Participants
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: "Does the Drug Have Any Bad Effects?"
Baseline
|
12.5 units on a scale
Standard Deviation 34.2
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: "Does the Drug Have Any Bad Effects?"
Peak
|
6.1 units on a scale
Standard Deviation 12.5
|
4.4 units on a scale
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1Population: Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.
A visual analog scale (VAS) was used by participants to answer the subjective question, "Do you like the drug?". The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no liking and 100=maximum liking.
Outcome measures
| Measure |
Sublingual Buprenorphine/Naloxone Soluble Film
n=16 Participants
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine Soluble Film
n=18 Participants
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
CVisual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: "Do You Like the Drug?"
Baseline
|
0.0 units on a scale
Standard Deviation 0.0
|
0.0 units on a scale
Standard Deviation 0.0
|
|
CVisual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: "Do You Like the Drug?"
Peak
|
59.4 units on a scale
Standard Deviation 34.1
|
61.2 units on a scale
Standard Deviation 40.0
|
SECONDARY outcome
Timeframe: Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1Population: Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.
A visual analog scale (VAS) was used by participants to answer the subjective question, "Does the drug make you sick?". The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect.
Outcome measures
| Measure |
Sublingual Buprenorphine/Naloxone Soluble Film
n=16 Participants
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine Soluble Film
n=18 Participants
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: "Does the Drug Make You Sick?"
Baseline
|
12.5 units on a scale
Standard Deviation 34.2
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: "Does the Drug Make You Sick?"
Peak
|
4.5 units on a scale
Standard Deviation 12.3
|
2.1 units on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5Population: Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.
A visual analog scale (VAS) was used by participants to answer the subjective question, "How high are you?". The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=not high and 100=extremely high.
Outcome measures
| Measure |
Sublingual Buprenorphine/Naloxone Soluble Film
n=16 Participants
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine Soluble Film
n=18 Participants
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: "How High Are You?"
End of Induction
|
6.3 units on a scale
Standard Deviation 25.0
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: "How High Are You?"
Peak Post Induction
|
12.9 units on a scale
Standard Deviation 30.1
|
8.2 units on a scale
Standard Deviation 18.2
|
SECONDARY outcome
Timeframe: End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5Population: Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.
A visual analog scale (VAS) was used by participants to answer the subjective question, "Do you feel any drug effect?". The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect.
Outcome measures
| Measure |
Sublingual Buprenorphine/Naloxone Soluble Film
n=16 Participants
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine Soluble Film
n=18 Participants
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: "Do You Feel Any Drug Effect?"
End of Induction
|
15.9 units on a scale
Standard Deviation 28.6
|
7.9 units on a scale
Standard Deviation 16.8
|
|
Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: "Do You Feel Any Drug Effect?"
Peak Post Induction
|
47.4 units on a scale
Standard Deviation 27.8
|
53.2 units on a scale
Standard Deviation 41.0
|
SECONDARY outcome
Timeframe: End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5Population: Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.
A visual analog scale (VAS) was used by participants to answer the subjective question, "Do you feel any good effects?". The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no good effects and 100=maximum good effects.
Outcome measures
| Measure |
Sublingual Buprenorphine/Naloxone Soluble Film
n=16 Participants
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine Soluble Film
n=18 Participants
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: "Do You Feel Any Good Effects?"
End of Induction
|
20.2 units on a scale
Standard Deviation 30.0
|
11.0 units on a scale
Standard Deviation 26.0
|
|
Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: "Do You Feel Any Good Effects?"
Peak Post Induction
|
52.9 units on a scale
Standard Deviation 33.1
|
61.7 units on a scale
Standard Deviation 39.8
|
SECONDARY outcome
Timeframe: End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5Population: Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.
A visual analog scale (VAS) was used by participants to answer the subjective question, "Does the drug have any bad effects?". The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no bad effects and 100=maximum bad effects.
Outcome measures
| Measure |
Sublingual Buprenorphine/Naloxone Soluble Film
n=16 Participants
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine Soluble Film
n=18 Participants
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: "Does the Drug Have Any Bad Effects?"
End of Induction
|
0.3 units on a scale
Standard Deviation 0.8
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: "Does the Drug Have Any Bad Effects?"
Peak Post Induction
|
0.4 units on a scale
Standard Deviation 1.2
|
0.4 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5Population: Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.
A visual analog scale (VAS) was used by participants to answer the subjective question, "Do you like the drug?". The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no liking and 100=maximum liking.
Outcome measures
| Measure |
Sublingual Buprenorphine/Naloxone Soluble Film
n=16 Participants
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine Soluble Film
n=18 Participants
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: "Do You Like the Drug?"
End of Induction
|
24.3 units on a scale
Standard Deviation 37.0
|
14.9 units on a scale
Standard Deviation 29.6
|
|
Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: "Do You Like the Drug?"
Peak Post Induction
|
55.4 units on a scale
Standard Deviation 35.8
|
61.7 units on a scale
Standard Deviation 41.0
|
SECONDARY outcome
Timeframe: End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5Population: Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.
A visual analog scale (VAS) was used by participants to answer the subjective question, "Does the drug make you sick?". The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect.
Outcome measures
| Measure |
Sublingual Buprenorphine/Naloxone Soluble Film
n=16 Participants
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine Soluble Film
n=18 Participants
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: "Does the Drug Make You Sick?"
End of Induction
|
0.3 units on a scale
Standard Deviation 0.7
|
0 units on a scale
Standard Deviation 0
|
|
Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: "Does the Drug Make You Sick?"
Peak Post Induction
|
0.7 units on a scale
Standard Deviation 1.6
|
0 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Day 1-6Population: The randomized population included all subjects who were randomized to soluble films and received at least one dose of soluble films.
Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6. Severity was graded by the investigator as mild (grade 1), moderate (grade 2) and severe (grade 3).
Outcome measures
| Measure |
Sublingual Buprenorphine/Naloxone Soluble Film
n=18 Participants
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine Soluble Film
n=20 Participants
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)
With any TEAE
|
18 participants
|
20 participants
|
|
Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)
With grade 1 TEAE
|
16 participants
|
15 participants
|
|
Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)
With grade 2 TEAE
|
16 participants
|
19 participants
|
|
Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)
With grade 3 TEAE
|
0 participants
|
0 participants
|
Adverse Events
Sublingual Buprenorphine Soluble Film
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Sublingual Buprenorphine/Naloxone Soluble Film
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sublingual Buprenorphine Soluble Film
n=20 participants at risk
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
Sublingual Buprenorphine/Naloxone Soluble Film
n=18 participants at risk
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.
Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
30.0%
6/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
16.7%
3/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Ear and labyrinth disorders
Lacrimation increased
|
20.0%
4/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
27.8%
5/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
16.7%
3/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
5/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
33.3%
6/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
5.6%
1/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.0%
3/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
0.00%
0/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
2/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
22.2%
4/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Gastrointestinal disorders
Nausea
|
30.0%
6/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
27.8%
5/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Gastrointestinal disorders
Stomach discomfort
|
45.0%
9/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
50.0%
9/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Gastrointestinal disorders
Toothache
|
10.0%
2/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
5.6%
1/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
16.7%
3/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
General disorders
Chills
|
10.0%
2/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
11.1%
2/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
General disorders
Cold sweat
|
30.0%
6/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
27.8%
5/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
General disorders
Hot flush
|
0.00%
0/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
11.1%
2/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
General disorders
Injection site erythema
|
0.00%
0/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
5.6%
1/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
General disorders
Injection site pruritus
|
0.00%
0/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
5.6%
1/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
General disorders
Irritability
|
25.0%
5/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
38.9%
7/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
5.6%
1/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Infections and infestations
Joint abscess
|
0.00%
0/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
5.6%
1/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
5.6%
1/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Investigations
Tuberculosis skin test positive
|
15.0%
3/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
5.6%
1/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Musculoskeletal and connective tissue disorders
Abscess limb
|
0.00%
0/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
5.6%
1/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
5/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
27.8%
5/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.0%
3/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
22.2%
4/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.0%
3/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
5.6%
1/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
5/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
5.6%
1/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
5.6%
1/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Nervous system disorders
Headache
|
55.0%
11/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
55.6%
10/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Nervous system disorders
Restlessness
|
45.0%
9/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
44.4%
8/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Nervous system disorders
Tremor
|
25.0%
5/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
11.1%
2/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Psychiatric disorders
Anxiety
|
45.0%
9/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
61.1%
11/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Psychiatric disorders
Drug withdrawal syndrome
|
70.0%
14/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
72.2%
13/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Psychiatric disorders
Hyperventilation
|
0.00%
0/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
5.6%
1/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Psychiatric disorders
Insomnia
|
65.0%
13/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
66.7%
12/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
5.6%
1/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
5.6%
1/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
50.0%
10/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
33.3%
6/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
20.0%
4/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
22.2%
4/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
5.6%
1/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Skin and subcutaneous tissue disorders
Piloerection
|
10.0%
2/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
38.9%
7/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
5.6%
1/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Skin and subcutaneous tissue disorders
Tinea pedis
|
0.00%
0/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
5.6%
1/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
2/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
0.00%
0/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
0.00%
0/18 • Days 1-6. Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.
Adverse event data were collected by the investigator during daily subject interviews.
|
Additional Information
Rolley E. Johnson, PharmD, Vice President, Clinical, Scientific and Regulatory Affairs
Reckitt Benckiser Pharmaceuticals, Inc.
Phone: 804-379-1090
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Proposed publications shall be submitted to Sponsor 30 days prior to submission for publication, and may be withheld for an additional period, up to 90 days, to allow Sponsor to file patent applications. If a multi-center publication isn't submitted for publication within 12 months of the conclusion of the Study at all sites, or is published in a shorter period, the results from the institution's site may be published individually.
- Publication restrictions are in place
Restriction type: OTHER