Status:
COMPLETED
Buprenorphine's Dose Response Curve
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid-related Disorders
Eligibility:
All Genders
21-55 years
Phase:
PHASE2
Brief Summary
This is a residential study that looks at the effects of buprenorphine in persons who abuse but are not dependent on opioids. Animal studies show that very high doses of buprenorphine produce less eff...
Detailed Description
Preclinical studies have demonstrated for a variety of measures that buprenorphine has a bell-shaped dose response curve. However, human studies with buprenorphine have not shown such an effect, altho...
Eligibility Criteria
Inclusion
- 1\. current opioid abuse but not physically dependent on opioids
Exclusion
- evidence of significant medical (e.g., insulin dependent diabetes) or psychiatric (e.g., schizophrenia) illness
- anemia defined as a hematocrit less than 30%
- females are required to provide a negative pregnancy test prior to study participation
- baseline electrocardiogram (ECG) showing prolongation of the corrected QT interval (QTc)
- current significant alcohol or sedative/hypnotic drug use
- Forced expiratory volume at one second (FEV1) of less than 50% at the time of screening
- applicants seeking treatment for their substance abuse will not be admitted to the study, and should be provided information about treatment services available
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00460239
Start Date
January 1 2007
End Date
July 1 2009
Last Update
March 3 2017
Active Locations (1)
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1
Johns Hopkins University (BPRU) Bayview Campus
Baltimore, Maryland, United States, 21224