| February 14, 2006 |
| June 19, 2008 |
| December 2004 |
| January 2012 (final data collection date for primary outcome measure) |
| abstinence from cocaine and heroin [ Time Frame: 16 weeks ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00292110 on ClinicalTrials.gov Archive Site |
- time to relapse [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Psychological and psychosocial outcome [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
- HIV Risk Behaviors [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
- QT interval [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- urine microalbuminuria [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- blood lipid profile [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
- Substance Dependence [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
- methadone plasma and saliva concentration [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
- cortisol and prolactin levels [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Treatment of Heroin and Cocaine With Methadone Maintenance and Contingency Management |
| Treatment of Heroin and Cocaine With Methadone Maintenance and Contingency Management |
The purpose of this study is to determine if simultaneous abstinence from heroin and cocaine can be elicited by combining two approaches: flexible methadone dosing and voucher-based contingency management in which patients earn incentives for cocaine abstinence. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment |
- Opiate-Related Disorders
- Cocaine-Related Disorders
|
- Behavioral: Contingency Management
- Drug: Methadone dose
- Behavioral: Contingency management/Noncontingent incentives
- Drug: Methadone
|
| |
| |
| |
| Recruiting |
| 300 |
| January 2012 |
| January 2012 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- physical dependence on opiates; requiring treatment for cocaine use; able to attend clinic seven days per week
Exclusion Criteria:
- medical or psychiatric conditions for which methadone is contraindicated; pregnancy; inability to give informed consent
|
| Both |
| 18 Years to 65 Years |
| No |
|
|
| United States |
| |
| NCT00292110 |
| Kenzie L. Preston, Ph.D., Principal Investigator, National Institute on Drug Abuse |
| NIDAIRP 390, Z01 DA 000175 |
| National Institute on Drug Abuse (NIDA) |
|
| Principal Investigator: |
Kenzie Preston, PhD |
NIDA Intramural Research Program |
|
|
| National Institute on Drug Abuse (NIDA) |
| June 2008 |
