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

Completed · Phase 2 · Has a placebo group

Conditions studied: Opioid-Related Disorders

In brief

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.

Key facts

Study ID

NCT00142909

Run by

Yale University

People needed

86

Starts

2005-02-01

Expected to finish

2009-01-01

Last updated by the study team

2015-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets DSM-IV criteria for opioid dependence
• Eligible to take a daily dose of 50 mg of naltrexone
• Normal EKG
• Able to read English

You may not qualify if…

• 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

Where it is running

• Yale University, Psychiatry — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.