Completed
Evaluation of Opioid Antagonist Activity in Humans
Led by Johns Hopkins University · Updated on 2017-03-03
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 effects than mid-range doses. This suggests that buprenorphine can be a very safe medication. However, no studies in humans have tested higher doses in a similar way. The goal of this study is to show the effects of single doses of buprenorphine, across a range of doses, in persons who are not physically dependent on opioids (but do abuse opioids).
CONDITIONS
Official Title
Buprenorphine's Dose Response Curve
Who Can Participate
Eligibility Criteria
You may qualify if you...
1. current opioid abuse but not physically dependent on opioids
You will not qualify if you...
- 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
Trial Site Locations
Total: 1 location
1
Johns Hopkins University (BPRU) Bayview Campus
Baltimore, Maryland, United States, 21224
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
8
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