At a glance
ClinicalIndex Comparison Record- ✓Meets DSM-IV criteria for opioid dependence
- ✓Eligible to take a daily dose of 50 mg of naltrexone
- ✓Normal EKG
- ✓Able to read English
- ✕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 currently being treated
- ✕Abstinent from opiates for more than 4 weeks prior to initiation of naltrexone
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Lofexidine: Enhancing Naltrexone Treatment for Opiate Addiction
In Brief
A Phase 2 clinical trial evaluating Lofexidine and Placebo for Opioid-Related Disorders. Completed, enrolled 86 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Participants will receive lofexidine. The dosing will be initiation at 0.4 mg bid and increased to 0.8mg in week 1 and 1.0 and 1.2 mg bid in week 2, and maintained at 1.2mg bid for weeks 3 to 12. They are then tapered down to 0 over the course of four days in week 12. While the target dose will be 2.4 mg daily, if any subject shows reduced tolerability at this or a lower dose, the dose will be adjusted to the maximum tolerated dose for that subject.
Lofexidine Placebo