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Buprenorphine's Dose Response Curve

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Eric Strain, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00460239
First received: April 11, 2007
Last updated: April 21, 2012
Last verified: April 2012

April 11, 2007
April 21, 2012
January 2007
July 2009   (final data collection date for primary outcome measure)
  • Opioid agonist effects (measured by Visual Analog Scales and other subjective ratings) [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
  • Physiologic effects (blood pressure, heart rate, temperature, respiratory rate, oxygen saturation, pupil diameter) [ Time Frame: 6.5 hours ] [ Designated as safety issue: Yes ]
  • Psychomotor/cognitive performance effects (measured by tasks such as the DSST and Trails B) [ Time Frame: 6.5 hours ] [ Designated as safety issue: Yes ]
  • Opioid agonist effects (measured by Visual Analog Scales and other subjective ratings)
  • Physiologic effects (blood pressure, heart rate, temperature, respiratory rate, oxygen saturation, pupil diameter)
  • Psychomotor/cognitive performance effects (measured by tasks such as the DSST and Trails B)
Complete list of historical versions of study NCT00460239 on ClinicalTrials.gov Archive Site
Pharmacokinetics (blood levels of buprenorphine and norbuprenorphine) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Pharmacokinetics (blood levels of buprenorphine and norbuprenorphine)
Not Provided
Not Provided
 
Buprenorphine's Dose Response Curve
Evaluation of Opioid Antagonist Activity in Humans

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Opioid-related Disorders
  • Drug: Buprenorphine
    IM, doses are blind; administered up to 1-2 times per week.
  • Drug: Morphine
    IM; up to 1-2 times per week; doses double blind
  • Drug: Placebo
    IM; double blind; once per week
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12
December 2012
July 2009   (final data collection date for primary outcome measure)

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
Both
21 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00460239
NIDA-08045-8, R01DA008045, DPMCDA
No
Eric Strain, MD, Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Eric C Strain, M.D. Johns Hopkins University
National Institute on Drug Abuse (NIDA)
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP