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| Descriptive Information Fields | |||||
| Brief Title † | Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1 - 4 | ||||
| Official Title † | Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1 | ||||
| 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 buprenorphine-naloxone maintained volunteers |
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| Detailed Description | Ongoing study - results 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 † | Subjective dose estimate Observed withdrawal rating Opioid agonist rating Opioid antagonist rating Pupil diameter Analog rating scale for drug effects Drug effect characteristics Drug/Money Preferences |
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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 † | Completed | ||||
| Enrollment † | 0 | ||||
| Start Date † | April 1999 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria: Individuals must be at least 18 yrs of age, currently opioid dependent and meet FDA critera for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency and have a history of IV opioid use. Exclusion Criteria: Individuals with evidence of anti 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 † | NCT00000329 | ||||
| Organization ID | NIDA-11160-4 | ||||
| Secondary IDs †† | R01-11160-4 | ||||
| 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 | April 1999 | ||||
| First Received Date † | September 20, 1999 | ||||
| Last Updated Date | November 3, 2005 | ||||
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