|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00460239 |
|
Date of registration:
|
11/04/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Buprenorphine's Dose Response Curve
|
|
Scientific title:
|
Evaluation of Opioid Antagonist Activity in Humans |
|
Date of first enrolment:
|
January 2007 |
|
Target sample size:
|
12 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00460239 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Eric C Strain, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Johns Hopkins University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. current opioid abuse but not physically dependent on opioids
Exclusion Criteria:
1. evidence of significant medical (e.g., insulin dependent diabetes) or psychiatric
(e.g., schizophrenia) illness
2. anemia defined as a hematocrit less than 30%
3. females are required to provide a negative pregnancy test prior to study
participation
4. baseline electrocardiogram (ECG) showing prolongation of the QTc interval
5. current significant alcohol or sedative/hypnotic drug use
6. FEV1 of less than 50% at the time of screening
7. applicants seeking treatment for their substance abuse will not be admitted to the
study, and should be provided information about treatment services available
Age minimum:
21 Years
Age maximum:
55 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Opioid-related Disorders
|
|
Intervention(s)
|
|
Drug: Buprenorphine
|
|
Drug: Morphine
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Opioid agonist effects (measured by Visual Analog Scales and other subjective ratings)
[Time Frame: 72 hours]
|
|
Physiologic effects (blood pressure, heart rate, temperature, respiratory rate, oxygen saturation, pupil diameter)
[Time Frame: 6.5 hours]
|
|
Psychomotor/cognitive performance effects (measured by tasks such as the DSST and Trails B)
[Time Frame: 6.5 hours]
|
|
Secondary Outcome(s)
|
|
Pharmacokinetics (blood levels of buprenorphine and norbuprenorphine)
[Time Frame: 72 hours]
|
|
Secondary ID(s)
|
|
DPMCDA
|
|
NIDA-08045-8
|
|
R01DA008045
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|