Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Chronic Pain
In brief
This study will evaluate whether crushed EMBEDA capsules induce clinical opiate withdrawal signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are stabilized on EMBEDA.
Key facts
- Study ID
- NCT01100437
- Run by
- Pfizer
- People needed
- 14
- Starts
- 2010-04-01
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2012-07-13
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Chronic moderate to severe non-cancer pain that has been treated with opioid analgesics for at least three months (with stabilized pain control and stabilized dose for 28 days prior to enrollment).
- Receiving an opioid dose equivalent to 20 mg - 120 mg morphine once or twice daily.
- Patient displays signs and symptoms of withdrawal (i.e., COWS score ≥5) following naloxone administration during the Naloxone Challenge.
- If female and able to become pregnant, must use an approved method of birth control.
- Excluding the chronic moderate to severe non-cancer pain, the patient is judged by the Investigator to be in generally good health at screening based upon the results of a medical history, physical examination, laboratory profile, and 12 lead electrocardiogram (ECG).
You may not qualify if…
- Female who is pregnant or breastfeeding.
- Patient has a known allergy or history of significant adverse reaction to morphine, other opioids, naltrexone, acetaminophen, or related compounds.
- Patient is receiving systemic chemotherapy, has an active malignancy of any type, or has been diagnosed with cancer within the 5 years prior to screening (excluding squamous or basal cell carcinoma of the skin).
- History of, or ongoing, alcohol or drug abuse.
- Patient has made a donation of blood or has had a significant blood loss within 30 days prior to screening.
Where it is running
- Lifetree Clinical Research — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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