Trial Outcomes & Findings for Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population (NCT NCT02038790)
NCT ID: NCT02038790
Last Updated: 2017-03-21
Results Overview
At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: When thinking about the two medications you evaluated over the last two days, which medication type did you prefer?
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
33 participants
Primary outcome timeframe
Day 1
Results posted on
2017-03-21
Participant Flow
Thirty nine (39) subjects were screened and thirty three (33) subjects were enrolled in the study.
Participant milestones
| Measure |
Suboxone - Zubsolv
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1.
|
Zubsolv - Suboxone
Participants received Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 0 and Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 1.
|
|---|---|---|
|
Day 0 - First Treatment
STARTED
|
16
|
17
|
|
Day 0 - First Treatment
COMPLETED
|
15
|
16
|
|
Day 0 - First Treatment
NOT COMPLETED
|
1
|
1
|
|
Day 1 - Second Treatment
STARTED
|
15
|
16
|
|
Day 1 - Second Treatment
COMPLETED
|
15
|
16
|
|
Day 1 - Second Treatment
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Suboxone - Zubsolv
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1.
|
Zubsolv - Suboxone
Participants received Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 0 and Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 1.
|
|---|---|---|
|
Day 0 - First Treatment
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population
Baseline characteristics by cohort
| Measure |
All Participants
n=33 Participants
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
|
|---|---|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: When thinking about the two medications you evaluated over the last two days, which medication type did you prefer?
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
|
Zubsolv Sublingual Tablets 5.7/1.4
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
|
|---|---|---|
|
Overall Intervention Preference As Assessed by Participants
Suboxone
|
54.84 percentage of participants
|
—
|
|
Overall Intervention Preference As Assessed by Participants
Zubsolv
|
45.16 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: Which one did you prefer in regards to overall taste?
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
|
Zubsolv Sublingual Tablets 5.7/1.4
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
|
|---|---|---|
|
Participant Preference With Regard to Overall Taste of Interventions
Suboxone
|
29.03 percentage of participants
|
—
|
|
Participant Preference With Regard to Overall Taste of Interventions
Zubsolv
|
70.97 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: Which one did you think dissolve easier in your mouth?
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
|
Zubsolv Sublingual Tablets 5.7/1.4
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
|
|---|---|---|
|
Participant Assessments With Regard to Ease of Dissolution of Interventions
Suboxone
|
19.35 percentage of participants
|
—
|
|
Participant Assessments With Regard to Ease of Dissolution of Interventions
Zubsolv
|
80.65 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Days 0-1Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
|
Zubsolv Sublingual Tablets 5.7/1.4
n=31 Participants
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
|
|---|---|---|
|
Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package?
Favorable response
|
61.29 percentage of participants
|
51.61 percentage of participants
|
|
Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package?
Unfavorable response
|
38.71 percentage of participants
|
48.39 percentage of participants
|
SECONDARY outcome
Timeframe: Days 0-1Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.
Outcome measures
| Measure |
All Participants
n=30 Participants
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
|
Zubsolv Sublingual Tablets 5.7/1.4
n=31 Participants
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
|
|---|---|---|
|
Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow?
Favorable response
|
100 percentage of participants
|
90.32 percentage of participants
|
|
Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow?
Unfavorable response
|
0 percentage of participants
|
9.68 percentage of participants
|
SECONDARY outcome
Timeframe: Days 0-1Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
|
Zubsolv Sublingual Tablets 5.7/1.4
n=31 Participants
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
|
|---|---|---|
|
Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth?
Favorable response
|
54.84 percentage of participants
|
77.42 percentage of participants
|
|
Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth?
Unfavorable response
|
45.16 percentage of participants
|
22.58 percentage of participants
|
SECONDARY outcome
Timeframe: Days 0-1Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
|
Zubsolv Sublingual Tablets 5.7/1.4
n=31 Participants
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
|
|---|---|---|
|
Percentage of Participant Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth?
Favorable response
|
54.84 percentage of participants
|
96.77 percentage of participants
|
|
Percentage of Participant Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth?
Unfavorable response
|
45.16 percentage of participants
|
3.23 percentage of participants
|
SECONDARY outcome
Timeframe: Days 0-1Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme.
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
|
Zubsolv Sublingual Tablets 5.7/1.4
n=31 Participants
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
|
|---|---|---|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?
0 (none)
|
67.74 percentage of participants
|
58.06 percentage of participants
|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?
1
|
19.35 percentage of participants
|
19.35 percentage of participants
|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?
2
|
6.45 percentage of participants
|
16.13 percentage of participants
|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?
3
|
3.23 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?
4
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?
5
|
3.23 percentage of participants
|
3.23 percentage of participants
|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?
6
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?
7
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?
8
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?
9 (extreme)
|
0 percentage of participants
|
3.23 percentage of participants
|
SECONDARY outcome
Timeframe: Days 0-1Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme.
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
|
Zubsolv Sublingual Tablets 5.7/1.4
n=31 Participants
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
|
|---|---|---|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?
0 (none)
|
70.97 percentage of participants
|
70.97 percentage of participants
|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?
1
|
22.58 percentage of participants
|
29.03 percentage of participants
|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?
2
|
3.23 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?
3
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?
4
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?
5
|
3.23 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?
6
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?
7
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?
8
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?
9 (extreme)
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Days 0-1Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Participant responses were captured on a 10-point scale with 0 = No high and 9= Extremely strong high.
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
|
Zubsolv Sublingual Tablets 5.7/1.4
n=31 Participants
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
|
|---|---|---|
|
Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High'
0 (no high)
|
70.97 percentage of participants
|
61.29 percentage of participants
|
|
Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High'
1
|
16.13 percentage of participants
|
32.26 percentage of participants
|
|
Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High'
2
|
9.68 percentage of participants
|
6.45 percentage of participants
|
|
Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High'
3
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High'
4
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High'
5
|
3.23 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High'
6
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High'
7
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High'
8
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High'
9 (extremely strong high)
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Days 0-1Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Participant responses were captured on a 10-point scale with 0 = No desire to abuse and 9= Extremely high desire to abuse.
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
|
Zubsolv Sublingual Tablets 5.7/1.4
n=31 Participants
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
|
|---|---|---|
|
Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication
5
|
3.23 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication
6
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication
0 (no high)
|
70.97 percentage of participants
|
61.29 percentage of participants
|
|
Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication
7
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication
1
|
16.13 percentage of participants
|
35.48 percentage of participants
|
|
Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication
2
|
9.68 percentage of participants
|
3.23 percentage of participants
|
|
Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication
8
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication
3
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication
9 (extremely strong high)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication
4
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Days 0-1Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Choices to the question above are: * Crush and snort * Liquefy and inject * Not able to abuse this formulation
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
|
Zubsolv Sublingual Tablets 5.7/1.4
n=31 Participants
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
|
|---|---|---|
|
Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to......
Crush and snort
|
0 percentage of participants
|
25.81 percentage of participants
|
|
Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to......
Liquefy and inject
|
0 percentage of participants
|
3.23 percentage of participants
|
|
Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to......
Not able to abuse this formulation
|
100 percentage of participants
|
70.97 percentage of participants
|
SECONDARY outcome
Timeframe: Days 0-1Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Choices to the question above are: * More effective as a treatment for opioid dependence * Equally effective as a treatment for opioid dependence * Less effective as a treatment for opioid dependence * The same medication that I normally use
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
|
Zubsolv Sublingual Tablets 5.7/1.4
n=31 Participants
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
|
|---|---|---|
|
Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was.....
More effective
|
3.23 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was.....
Equally effective
|
29.03 percentage of participants
|
51.61 percentage of participants
|
|
Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was.....
Less effective
|
0 percentage of participants
|
32.26 percentage of participants
|
|
Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was.....
Same medication I normally use
|
67.74 percentage of participants
|
16.13 percentage of participants
|
SECONDARY outcome
Timeframe: Days 0-1Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
The subject was observed and times documented for time of administration and time dissolution (recorded in minutes and seconds) was completed by designated qualified study personnel at the site.
Outcome measures
| Measure |
All Participants
n=32 Participants
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
|
Zubsolv Sublingual Tablets 5.7/1.4
n=32 Participants
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
|
|---|---|---|
|
Dissolution Time of Intervention as Recorded by a Trained Observer
|
6.59 minutes
Standard Deviation 5.28
|
2.98 minutes
Standard Deviation 2.48
|
SECONDARY outcome
Timeframe: Day 0 prior to dosing, end of Day 0 (post dose), end of Day 1 (post dose)Population: Per protocol set.
Participants completed the Subject Opiate Withdrawal Scale (SOWS) at baseline, and the end of each day of treatment. SOWS is a validated scale when used as defined. The research site did not use SOWS as defined. The sponsor made the decision to not report this data since it was not captured in a validated format.
Outcome measures
Outcome data not reported
Adverse Events
Suboxone Sublingual Film 8/2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Zubsolv Sublingual Tablets 5.7/1.4
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Suboxone Sublingual Film 8/2
n=32 participants at risk
Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
|
Zubsolv Sublingual Tablets 5.7/1.4
n=32 participants at risk
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Rhinnorhoea
|
0.00%
0/32 • Days 0 (post treatment) -1
|
3.1%
1/32 • Days 0 (post treatment) -1
|
|
Nervous system disorders
Somnolence
|
0.00%
0/32 • Days 0 (post treatment) -1
|
3.1%
1/32 • Days 0 (post treatment) -1
|
|
General disorders
Drug withdrawal syndrome
|
6.2%
2/32 • Days 0 (post treatment) -1
|
25.0%
8/32 • Days 0 (post treatment) -1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/32 • Days 0 (post treatment) -1
|
6.2%
2/32 • Days 0 (post treatment) -1
|
|
Nervous system disorders
Headache
|
0.00%
0/32 • Days 0 (post treatment) -1
|
3.1%
1/32 • Days 0 (post treatment) -1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/32 • Days 0 (post treatment) -1
|
3.1%
1/32 • Days 0 (post treatment) -1
|
|
General disorders
Oedema peripheral
|
3.1%
1/32 • Days 0 (post treatment) -1
|
0.00%
0/32 • Days 0 (post treatment) -1
|
|
General disorders
Fatigue
|
0.00%
0/32 • Days 0 (post treatment) -1
|
3.1%
1/32 • Days 0 (post treatment) -1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/32 • Days 0 (post treatment) -1
|
3.1%
1/32 • Days 0 (post treatment) -1
|
Additional Information
Global Director Clinical Development
Indivior, Inc.
Phone: 804-379-1090
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