Overview

This trial is active, not recruiting.

Condition opioid-related disorders
Treatments buprenorphine, morphine, placebo
Phase phase 2
Sponsor National Institute on Drug Abuse (NIDA)
Start date January 2007
End date July 2009
Trial size 12 participants
Trial identifier NCT00460239, DPMCDA, NIDA-08045-8, R01DA008045

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model crossover assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment

Primary Outcomes

Measure
Opioid agonist effects (measured by Visual Analog Scales and other subjective ratings)
time frame: 72 hours
Physiologic effects (blood pressure, heart rate, temperature, respiratory rate, oxygen saturation, pupil diameter)
time frame: 6.5 hours
Psychomotor/cognitive performance effects (measured by tasks such as the DSST and Trails B)
time frame: 6.5 hours

Secondary Outcomes

Measure
Pharmacokinetics (blood levels of buprenorphine and norbuprenorphine)
time frame: 72 hours

Eligibility Criteria

Male or female participants from 21 years up to 55 years old.

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 QTc interval 5. current significant alcohol or sedative/hypnotic drug use 6. 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

Additional Information

Official title Evaluation of Opioid Antagonist Activity in Humans
Principal investigator Eric C Strain, M.D.
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, although controlled studies have generally not tested higher acute doses of buprenorphine. Current clinical recommendations generally place an upper limit of daily buprenorphine dosing at 32 mg of sublingual tablets, although considerably higher acute doses have been administered to humans (primarily in clinical studies of less than daily dosing). Determining the relationship between higher doses of buprenorphine in humans and effects produced would be valuable; it would be scientifically interesting to demonstrate a bell-shaped curve in humans, and it would help guide clinical practice (for example, with respect to dosing, safety, and side effect considerations. The purpose of this study is to characterize the dose response curve for buprenorphine in humans, utilizing acute single doses of parenteral buprenorphine.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by National Institute on Drug Abuse (NIDA).