Buprenorphine's Dose Response Curve

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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 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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University; National Institute on Drug Abuse (NIDA)
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Analgesics, Opioid; Buprenorphine; Morphine

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 corrected QT interval (QTc)

5. current significant alcohol or sedative/hypnotic drug use

6. Forced expiratory volume at one second (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