Trial Outcomes & Findings for Reinforcing Effects of Intranasal (IN) Buprenorphine Versus Buprenorphine/Naloxone (NCT NCT01760473)
NCT ID: NCT01760473
Last Updated: 2017-09-08
Results Overview
The maximum number of responses (clicks on a computer mouse) the participant was willing to perform in order to receive a dose of the intranasal challenge drug under investigation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
27 participants
Primary outcome timeframe
Throughout the testing sessions (approximately 9 weeks).
Results posted on
2017-09-08
Participant Flow
Participant milestones
| Measure |
Intranasal Challege Drug
Each of the 9 experimental challenge drugs were administered intranasally to all participants in random order. This study employed a Latin-square randomization procedure, therefore, the testing order of the 9 IN doses was unique for each participant.
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|---|---|
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Overall Study
STARTED
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27
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Overall Study
COMPLETED
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12
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Overall Study
NOT COMPLETED
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15
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reinforcing Effects of Intranasal (IN) Buprenorphine Versus Buprenorphine/Naloxone
Baseline characteristics by cohort
| Measure |
Intranasal Challege Drug
n=27 Participants
Each of the 9 experimental challenge drugs were administered intranasally to all participants in random order.
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|---|---|
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Age, Continuous
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39.3 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
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Sex: Female, Male
Female
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1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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10 Participants
n=5 Participants
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Race (NIH/OMB)
White
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10 Participants
n=5 Participants
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|
Race (NIH/OMB)
More than one race
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3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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3 Participants
n=5 Participants
|
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Region of Enrollment
United States
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27 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Throughout the testing sessions (approximately 9 weeks).The maximum number of responses (clicks on a computer mouse) the participant was willing to perform in order to receive a dose of the intranasal challenge drug under investigation.
Outcome measures
| Measure |
Bup 8
n=12 Participants
Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally.
Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.
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Bup 16
n=12 Participants
Intranasal challenge drug: 16 mg of Buprenorphine administered intranasally.
Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.
|
Bup/Nal 8/2
n=12 Participants
Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 2 mg of Naloxone.
Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.
|
Bup/Nal 8/8
n=12 Participants
Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 8 mg of Naloxone.
Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.
|
Bup/Nal 8/16
n=12 Participants
Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 16 mg of Naloxone.
Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.
|
Bup/Nal 16/4
n=12 Participants
Intranasal challenge drug: 16 mg of Buprenorphine administered intranasally with 4 mg of Naloxone.
Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.
|
Heroin
n=12 Participants
Intranasal challenge drug: 24 mg of heroin administered intranasally.
Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.
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Placebo
n=12 Participants
Intranasal challenge drug: Intranasal lactose powder.
Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.
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Naloxone 4 mg
n=12 Participants
Intranasal challenge drug: Intranasal Naloxone 4mg.
Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.
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Drug Self-administration
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350 Clicks on a computer mouse
Standard Error 135
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255 Clicks on a computer mouse
Standard Error 121
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223 Clicks on a computer mouse
Standard Error 113
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113 Clicks on a computer mouse
Standard Error 83
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2.7 Clicks on a computer mouse
Standard Error 2.7
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191 Clicks on a computer mouse
Standard Error 112
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755 Clicks on a computer mouse
Standard Error 156
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38 Clicks on a computer mouse
Standard Error 23
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45 Clicks on a computer mouse
Standard Error 30
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SECONDARY outcome
Timeframe: Throughout the testing sessions (approximately 9 weeks).Subjective opioid withdrawal scale (SOWS) measure (0-64). Greater score indicates more severe withdrawal.
Outcome measures
| Measure |
Bup 8
n=12 Participants
Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally.
Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.
|
Bup 16
n=12 Participants
Intranasal challenge drug: 16 mg of Buprenorphine administered intranasally.
Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.
|
Bup/Nal 8/2
n=12 Participants
Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 2 mg of Naloxone.
Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.
|
Bup/Nal 8/8
n=12 Participants
Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 8 mg of Naloxone.
Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.
|
Bup/Nal 8/16
n=12 Participants
Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 16 mg of Naloxone.
Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.
|
Bup/Nal 16/4
n=12 Participants
Intranasal challenge drug: 16 mg of Buprenorphine administered intranasally with 4 mg of Naloxone.
Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.
|
Heroin
n=12 Participants
Intranasal challenge drug: 24 mg of heroin administered intranasally.
Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.
|
Placebo
n=12 Participants
Intranasal challenge drug: Intranasal lactose powder.
Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.
|
Naloxone 4 mg
n=12 Participants
Intranasal challenge drug: Intranasal Naloxone 4mg.
Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.
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|---|---|---|---|---|---|---|---|---|---|
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SOWS
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3 units on a scale
Standard Error .5
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3 units on a scale
Standard Error .7
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3 units on a scale
Standard Error .9
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3 units on a scale
Standard Error .8
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5 units on a scale
Standard Error 1
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3 units on a scale
Standard Error .5
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2 units on a scale
Standard Error .3
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2 units on a scale
Standard Error .53
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7 units on a scale
Standard Error 1
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Adverse Events
Intranasal Challege Drug
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intranasal Challege Drug
n=27 participants at risk
Each of the 9 experimental challenge drugs were administered intranasally to all participants in a randomized order. Therefore, the testing sequence for each of the participants was unique. Although we assessed for some averse events on a daily basis, other measures of health (e.g., blood chemistry) were assessed on a weekly basis. As multiple doses were tested during the week, therefore, in some cases we cannot causally connect some AEs to any individual drug/testing condition.
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|---|---|
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Metabolism and nutrition disorders
Elevated liver function test (AST/ALT)
|
7.4%
2/27 • Number of events 2 • Adverse events were collected from the day of admission until discharge and at 3 month follow-up
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place