Phase 2
N=12
Buprenorphine's Dose Response Curve
Opioid-related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00460239 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Peak Change From Baseline in Drug Effect Assessed by Visual Analog Scale (VAS) — 17.75; 27.25; 29.63; 58.25 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Buprenorphine (Drug); Morphine (Drug); Placebo (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Change From Baseline in Drug Effect Assessed by Visual Analog Scale (VAS) |
17.75; 27.25; 29.63; 58.25; 48.50; 40.25 | — |
| PRIMARY Psychomotor/Cognitive Performance Effects Assessed by Digit Symbol Substitution Test (DSST) |
94.03; 91.60; 89.44; 90.91; 86.60; 83.17 | — |
| PRIMARY Psychomotor/Cognitive Performance Effects Assessed by Trails B |
1.58; 1.51; 1.68; 1.57; 1.85; 1.42 | — |
| PRIMARY Physiologic Effects as Assessed by Blood Pressure |
114.11; 114.71; 119.21; 118.59; 111.42; 114.11 | — |
| PRIMARY Physiologic Effects as Assessed by Heart Rate |
70.44; 70.56; 69.80; 71.22; 69.41; 66.44 | — |
| PRIMARY Physiologic Effects as Assessed by Body Temperature |
85.99; 87.43; 89.20; 89.76; 90.33; 89.11 | — |
| PRIMARY Physiologic Effects as Assessed by Oxygen Saturation |
97.81; 97.57; 97.15; 96.94; 96.73; 96.37 | — |
| PRIMARY Physiologic Effects as Assessed by Pupil Diameter |
4.00; 3.33; 2.74; 2.87; 2.73; 2.63 | — |
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).
Eligibility Criteria
Inclusion Criteria
- current opioid abuse but not physically dependent on opioids
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00460239). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.