Effectiveness of Lofexidine to Prevent Stress-Related Opiate Relapse During Naltrexone Treatment - 1

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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 whether lofexidine in combination with naltrexone can improve an individual's ability to cope with stress and subsequently increase the chances of remaining abstinent from opiates.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Clonidine; Lofexidine; Naltrexone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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