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Trial record 71 of 186 for:    BUPRENORPHINE AND NALOXONE

Abuse Liability of Suboxone Versus Subutex

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00710385
Recruitment Status : Completed
First Posted : July 4, 2008
Results First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Collaborator:
Schering-Plough
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 Opioid-related Disorders
Interventions Drug: Heroin
Drug: Naloxone
Drug: Low Bup Dose
Drug: High Bup Dose
Drug: Low Bup/Nal Dose
Drug: High Bup/Nal Dose
Drug: Placebo (PCB)
Enrollment 19
Recruitment Details Enrollment dates: September 10, 2007 - August 13, 2008 Location: Medical clinic
Pre-assignment Details  
Arm/Group Title Intravenous Challenge Doses
Hide Arm/Group Description This study employs a within-subjects design, all participants experienced all 7 intravenous challenge doses. The challenge doses were administered under 3 sublingual buprenorphine maintenance conditions. The data presented were collapsed across the 3 sublingual groups.
Period Title: Overall Study
Started 17 [1]
Completed 12
Not Completed 5
Reason Not Completed
Did not qualify             1
Withdrawal by Subject             1
Undisclosed back pain             1
Physician Decision             1
Undisclosed excessive methadone use             1
[1]
19 participants signed consent for the study 2 withdrew before any study procedures were initiated.
Arm/Group Title Challenge Doses
Hide Arm/Group Description This study employs a within-subjects design, all participant experience all challenge doses.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
[1]
Measure Description: verbal report verified by ID
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
36.2  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
4
  33.3%
Male
8
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Drug's Breakpoint
Hide Description Measure of a drug's reinforcing effects. The "Breakpoint" is the point at which the participant stop performing an operant task (clicks on a mouse) in order to received the drug. Therefore, the reported breakpoint is the total amount of work the participant was willing to perform to receive the dose being tested
Time Frame Single measurement taken following each of the 7 IV experimental doses
Hide Outcome Measure Data
Hide Analysis Population Description
Heroin users, not seeking treatment
Arm/Group Title Heroin Naloxone Low Bup Dose High Bup Dose Lower Bup/Nal Dose High Bup/Nal Dose Placebo
Hide Arm/Group Description:
Intravenous heroin 25 mg
Intravenous Naloxone HCl
Lower doses of intravenous buprenorphine alone.
Higher doses of intravenous buprenorphine
Lower doses of intravenous buprenorphine + naloxone.
Higher doses of intravenous buprenorphine +naloxone
Control intravenous placebo drug administration.
Overall Number of Participants Analyzed 12 12 12 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: number of clicks on a mouse
1200  (200) 10  (10) 1100  (180) 1200  (190) 300  (100) 750  (175) 0  (0)
2.Secondary Outcome
Title Drug "Liking"
Hide Description Participant's subjective ratings of how much they "Like" the dose they just received on a scale of 0 -100.
Time Frame Peak (highest) rating obtained following drug administration throughout the entire 3 hr session
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Heroin Naloxone Low Bup Dose High Bup Dose Lower Bup/Nal Dose High Bup/Nal Dose Placebo
Hide Arm/Group Description:
Intravenous heroin 25 mg
Intravenous Naloxone HCl
Lower doses of intravenous buprenorphine alone.
Higher doses of intravenous buprenorphine
Lower doses of intravenous buprenorphine + naloxone.
Higher doses of intravenous buprenorphine +naloxone
Control intravenous placebo drug administration.
Overall Number of Participants Analyzed 12 12 12 12 12 12 12
Mean (Standard Error)
Unit of Measure: units on a scale
41.5  (5) 3  (2.7) 29.8  (4) 42.5  (5) 10.5  (2.4) 27  (4) 1  (.6)
Time Frame Adverse events were assessed for daily throughout the study.
Adverse Event Reporting Description An adverse event (AE) was defined as any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A serious adverse event is any AE that was: Fatal, Life-threatening, Required or prolonged inpatient stay, Resulted in persistent or significant disability or incapacity.
 
Arm/Group Title Combined for All Study Conditions
Hide Arm/Group Description This study employed a within-subjects design, all participants experienced all study conditions.
All-Cause Mortality
Combined for All Study Conditions
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Combined for All Study Conditions
Affected / at Risk (%) # Events
Total   0/17 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Combined for All Study Conditions
Affected / at Risk (%) # Events
Total   4/17 (23.53%)    
Gastrointestinal disorders   
vomiting   1/17 (5.88%)  1
Injury, poisoning and procedural complications   
dizziness   1/17 (5.88%)  1
chest discomfort   1/17 (5.88%)  1
Mild Opioid Withdrawal   3/17 (17.65%)  3
Skin and subcutaneous tissue disorders   
urticaria   2/17 (11.76%)  2
Indicates events were collected by systematic assessment
The stringent criteria for enrollment, qualification and retention in this trial were highly selective for a certain subpopulation of opioid-dependent individuals.
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: Sandra D. Comer
Organization: Substance Abuse
Phone: 646-774-6146
EMail: sdc10@columbia.edu
Layout table for additonal information
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00710385     History of Changes
Other Study ID Numbers: 5518
First Submitted: June 11, 2008
First Posted: July 4, 2008
Results First Submitted: August 19, 2011
Results First Posted: December 5, 2016
Last Update Posted: December 5, 2016