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| Descriptive Information Fields | |||||
| Brief Title † | Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-3 - 6 | ||||
| Official Title † | Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-3 | ||||
| Brief Summary | The purpose of this study is to assess the abuse liability and examine the reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in healthy, non-drug dependent volunteers. |
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| Detailed Description | not available at this time |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Double-Blind, Placebo Control | ||||
| Primary Outcome Measure † | Observed withdrawal rating Pupil diameter Drug effect characteristics |
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| Secondary Outcome Measure † | |||||
| Condition † | Heroin Dependence Opioid-Related Disorders |
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| Intervention † | Drug: Opioid-Related Disorders | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Terminated | ||||
| Enrollment † | 0 | ||||
| Start Date † | |||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria: Individuals must be healthy, non-drug dependent volunteers, be at least 18 years of age, and have no prior history of drug or alcohol abuse or dependence. Subjects must have had some minimal experience with opioids (e.g. at least two prior exposures) Exclusion Criteria: Individuals with evidence of an active DSM-IV Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g., liver or cardiovascular disease) or pregnant female subjects are excluded from study participation. |
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00000331 | ||||
| Organization ID | NIDA-11160-6 | ||||
| Secondary IDs †† | R01-11160-6 | ||||
| Study Sponsor † | National Institute on Drug Abuse (NIDA) | ||||
| Collaborators †† | University of Colorado at Denver and Health Sciences Center | ||||
| Investigators † |
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| Information Provided By | National Institute on Drug Abuse (NIDA) | ||||
| Verification Date | December 2002 | ||||
| First Received Date † | September 20, 1999 | ||||
| Last Updated Date | November 3, 2005 | ||||