Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
The decision to terminate the trial was due to a lack of study drug supply. Decision was not based on any safety concerns. The date of the notification of termination letter was March 11, 2011.
Age
21–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients
