Buprenorphine's Dose Response Curve
Completed · Phase 2 · Has a placebo group
Conditions studied: Opioid-related Disorders
In brief
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).
Key facts
- Study ID
- NCT00460239
- Run by
- Johns Hopkins University
- People needed
- 12
- Starts
- 2007-01-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2017-03-03
Who can join
Age: 21 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- current opioid abuse but not physically dependent on opioids
You may not qualify if…
- 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
Where it is running
- Johns Hopkins University (BPRU) Bayview Campus — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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