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Buprenorphine's Dose Response Curve

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00460239
First Posted: April 13, 2007
Last Update Posted: March 3, 2017
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.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: August 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Opioid-related Disorders
Interventions: Drug: Buprenorphine
Drug: Morphine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Condition 1 Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, B32, B48, B60, M15, M30, P.
Condition 2 Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, B32, M15, B48, P, B60, M30.
Condition 3 Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, B32, B48, M30, B60, P, M15.
Condition 4 Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, M15, B16, P, B32, M30, B48, B60.
Condition 5 Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, M30, B32, P, B48, M15, B60.
Condition 6 Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): M15, P, B8, M30, B16, B32, P, B48, B60.
Condition 7 Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): M30, B8, P, B16, M15, B32, B48, B60.
Condition 8 Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): P, M30, M15, B8, B16, B32, B48, B60.
Condition 9 Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): M15, B8, B16, B32, M30, P, B48, B60.

Participant Flow:   Overall Study
    Condition 1   Condition 2   Condition 3   Condition 4   Condition 5   Condition 6   Condition 7   Condition 8   Condition 9
STARTED   0   3   1   0   1   4   1   1   1 
COMPLETED   0   2   1   0   1   1   1   1   1 
NOT COMPLETED   0   1   0   0   0   3   0   0   0 
Physician Decision                0                1                0                0                0                2                0                0                0 
Withdrawal by Subject                0                0                0                0                0                1                0                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Study Participants All Study Participants

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      12 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.2  (6.48) 
Gender 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      12 100.0% 
Region of Enrollment 
[Units: Participants]
 
United States   12 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Peak Change From Baseline in Drug Effect Assessed by Visual Analog Scale (VAS)   [ Time Frame: Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) ]

2.  Primary:   Psychomotor/Cognitive Performance Effects Assessed by Digit Symbol Substitution Test (DSST)   [ Time Frame: Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) ]

3.  Primary:   Psychomotor/Cognitive Performance Effects Assessed by Trails B   [ Time Frame: Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) ]

4.  Primary:   Physiologic Effects as Assessed by Blood Pressure   [ Time Frame: Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) ]

5.  Primary:   Physiologic Effects as Assessed by Heart Rate   [ Time Frame: Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) ]

6.  Primary:   Physiologic Effects as Assessed by Body Temperature   [ Time Frame: Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) ]

7.  Primary:   Physiologic Effects as Assessed by Oxygen Saturation   [ Time Frame: Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) ]

8.  Primary:   Physiologic Effects as Assessed by Pupil Diameter   [ Time Frame: Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Eric C. Strain, M.D.
Organization: Johns Hopkins University School of Medicine
phone: 410-550-1191
e-mail: ecsgss@aol.com



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00460239     History of Changes
Other Study ID Numbers: NIDA-08045-8
5R01DA008045-08 ( U.S. NIH Grant/Contract )
R01DA008045 ( U.S. NIH Grant/Contract )
DPMCDA ( Other Identifier: NIDA )
First Submitted: April 11, 2007
First Posted: April 13, 2007
Results First Submitted: August 18, 2012
Last Update Posted: March 3, 2017