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Reinforcing Effects of Intranasal (IN) Buprenorphine Versus Buprenorphine/Naloxone

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ClinicalTrials.gov Identifier: NCT01760473
Recruitment Status : Completed
First Posted : January 4, 2013
Results First Posted : September 8, 2017
Last Update Posted : September 8, 2017
Sponsor:
Collaborator:
Indivior Inc.
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Heroin Dependence
Intervention Drug: Intranasal challenge drug
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intranasal Challege Drug
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 27
Completed 12
Not Completed 15
Arm/Group Title Intranasal Challege Drug
Hide Arm/Group Description Each of the 9 experimental challenge drugs were administered intranasally to all participants in random order.
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
39.3  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
1
   3.7%
Male
26
  96.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   3.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
10
  37.0%
White
10
  37.0%
More than one race
3
  11.1%
Unknown or Not Reported
3
  11.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants
27
1.Primary Outcome
Title Drug Self-administration
Hide Description 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.
Time Frame Throughout the testing sessions (approximately 9 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bup 8 Bup 16 Bup/Nal 8/2 Bup/Nal 8/8 Bup/Nal 8/16 Bup/Nal 16/4 Heroin Placebo Naloxone 4 mg
Hide Arm/Group Description:

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.

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.

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.

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.

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.

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.

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.

Intranasal challenge drug: Intranasal lactose powder.

Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.

Intranasal challenge drug: Intranasal Naloxone 4mg.

Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.

Overall Number of Participants Analyzed 12 12 12 12 12 12 12 12 12
Mean (Standard Error)
Unit of Measure: Clicks on a computer mouse
350  (135) 255  (121) 223  (113) 113  (83) 2.7  (2.7) 191  (112) 755  (156) 38  (23) 45  (30)
2.Secondary Outcome
Title SOWS
Hide Description Subjective opioid withdrawal scale (SOWS) measure (0-64). Greater score indicates more severe withdrawal.
Time Frame Throughout the testing sessions (approximately 9 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bup 8 Bup 16 Bup/Nal 8/2 Bup/Nal 8/8 Bup/Nal 8/16 Bup/Nal 16/4 Heroin Placebo Naloxone 4 mg
Hide Arm/Group Description:

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.

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.

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.

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.

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.

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.

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.

Intranasal challenge drug: Intranasal lactose powder.

Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.

Intranasal challenge drug: Intranasal Naloxone 4mg.

Intranasal challenge drug: Each of the experimental challenge drugs were administered intranasally to all participants in random order.

Overall Number of Participants Analyzed 12 12 12 12 12 12 12 12 12
Mean (Standard Error)
Unit of Measure: units on a scale
3  (.5) 3  (.7) 3  (.9) 3  (.8) 5  (1) 3  (.5) 2  (.3) 2  (.53) 7  (1)
Time Frame Adverse events were collected from the day of admission until discharge and at 3 month follow-up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intranasal Challege Drug
Hide Arm/Group Description 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.
All-Cause Mortality
Intranasal Challege Drug
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intranasal Challege Drug
Affected / at Risk (%) # Events
Total   0/27 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intranasal Challege Drug
Affected / at Risk (%) # Events
Total   2/27 (7.41%)    
Metabolism and nutrition disorders   
Elevated liver function test (AST/ALT)  [1]  2/27 (7.41%)  2
Indicates events were collected by systematic assessment
[1]
Liver function rose to greater than 3 x the upper limit of normal. Blood chemistry was performed on a weekly basis throughout the 9 weeks. As multiple doses were tested during the week, we cannot attribute this AE to any individual drug condition.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sandra Comer
Organization: New York State Psychiatric Institute
Phone: 646 774-6146
EMail: sdc10@columbia.edu
Layout table for additonal information
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01760473     History of Changes
Other Study ID Numbers: #5879
First Submitted: May 1, 2009
First Posted: January 4, 2013
Results First Submitted: October 11, 2016
Results First Posted: September 8, 2017
Last Update Posted: September 8, 2017