Status:
COMPLETED
Effectiveness of Lofexidine to Prevent Stress-Related Opiate Relapse During Naltrexone Treatment - 1
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid-Related Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Lofexidine is an experimental medication that may be beneficial in reducing opiate withdrawal symptoms, such as sleep difficulty, anxiety, and tension. The purpose of this study is to determine whethe...
Detailed Description
Naltrexone is a medication currently used to treat opiate dependence. Naltrexone blocks the euphoric effects of opiates. However, naltrexone treatment suffers from high rates of drop-out and relapse. ...
Eligibility Criteria
Inclusion
- Meets DSM-IV criteria for opioid dependence
- Eligible to take a daily dose of 50 mg of naltrexone
- Normal EKG
- Able to read English
Exclusion
- Currently psychotic or psychiatrically disabled (e.g., suicidal, homicidal, manic)
- Regular use of anticonvulsants, sedatives/hypnotics, prescription analgesics, antihypertensives (including clonidine), antiarrhythmics, antiretroviral medications, or tricyclic antidepressants
- Underlying medical conditions, such as cerebral, kidney, thyroid, or cardiac pathology, and currently taking medications for any of these conditions
- Abstinent from opiates for more than 4 weeks prior to initiation of naltrexone
- Medical problems precluding naltrexone treatment, such as hepato-cellular injury, as evidenced by abnormal liver enzyme tests (greater than three times the normal level) and a history of cirrhosis
- Hypotensive (resting blood pressure below 90/50 mm Hg)
- Pregnant or breastfeeding
- Use of an investigational drug within the 3 months prior to enrollment
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00142909
Start Date
February 1 2005
End Date
January 1 2009
Last Update
July 30 2015
Active Locations (1)
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1
Yale University, Psychiatry
New Haven, Connecticut, United States, 06519