Assessing Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00134875|
Recruitment Status : Terminated
First Posted : August 25, 2005
Last Update Posted : January 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Opioid-Related Disorders||Drug: Buprenorphine/naloxone||Not Applicable|
Naloxone has been combined with buprenorphine to decrease the parenteral abuse potential of buprenorphine in opioid dependent individuals through the mechanism of naloxone-precipitated withdrawal. While naloxone will not precipitate withdrawal in individuals who are not physically dependent on opioids, it is possible naloxone might attenuate buprenorphine's agonist effects, especially if administered parenterally. The purpose of this study is to assess the effect of sublingual (SL) and intramuscular (IM) buprenorphine and buprenorphine/naloxone in non-dependent opioid abusers.
Participants will stay on a research ward and will undergo challenge sessions twice per week. The following conditions will be tested: placebo; IM hydromorphone (2 and 4 mg; an opioid agonist positive control condition); SL buprenorphine (4, 8, and 16 mg); IM buprenorphine (4, 8, and 16 mg); SL buprenorphine/naloxone(4/1, 8/2, and 16/4 mg); and IM buprenorphine/naloxone (4/1, 8/2, and 16/4 mg). During challenge sessions, physiological status will be recorded continuously and tasks assessing psychomotor, subjective, and objective status will be performed repeatedly.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers|
|Study Start Date :||December 2000|
|Actual Primary Completion Date :||December 2002|
|Estimated Study Completion Date :||December 2017|
- Drug: Buprenorphine/naloxone
Acute doses of buprenorphine/naloxone in each experimental test session. Doses delivered by either sublingual or parenteral routes, and are: 4/1, 8/2, 16/4 mg.
- Opioid agonist effects [ Time Frame: 3.5 hours ]
- Physiologic measures [ Time Frame: 3.5 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134875
|United States, Maryland|
|Johns Hopkins University (BPRU) Bayview Campus|
|Baltimore, Maryland, United States, 21224 6823|
|Principal Investigator:||Eric C. Strain, M.D.||Johns Hopkins University|