Status:
WITHDRAWN
Testing a Primary Care Model for the Treatment of Opioid Dependence Using Long-acting Injectable Naltrexone (Vivitrol).
Lead Sponsor:
Yale University
Conditions:
Drug Dependence
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
In opioid dependent patients treated with long-acting injectable naltrexone (Vivitrol ®), we will compare the efficacy of a primary care model of counseling (Condition 1) versus individualized cogniti...
Eligibility Criteria
Inclusion
- Male or female individuals, ages 18 and above, meeting current diagnostic and statistical manual (DSM-IV) criteria for opioid dependence.
- Subject has voluntarily given informed consent and signed the informed consent document.
- Able to read English and complete study evaluations.
Exclusion
- Regular use of benzodiazepines.
- Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
- Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study;
- Abstinent from opiates for more than four weeks prior to naltrexone initiation.
- Medical problems that would preclude naltrexone treatment, such as laboratory evidence of significant hepato-cellular injury as evidenced by abnormal liver enzyme tests including SGOT and SGPT (\> three times normal) or elevated bilirubin levels), and a history of cirrhosis.
- Women who are pregnant, nursing or refuse to use a reliable form of birth control (as assessed by pregnancy tests during initial evaluation for naltrexone, and every two weeks during the course of the study).
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00675532
Start Date
May 1 2011
End Date
August 1 2013
Last Update
July 22 2013
Active Locations (1)
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1
Yale New Haven Hospital Primary Care Center
New Haven, Connecticut, United States, 06519