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Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients

TerminatedPhase 4NCT01100437
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
A Single-Center, Randomized, Double-Blind, Two-Way Crossover Study to Evaluate Whether a Single-Dose Administration of Crushed and Whole EMBEDA Induces Clinical Opiate Withdrawal Signs and Symptoms in Opioid-Dependent Patients With Chronic, Non-Cancer Pain Who Are Stabilized on EMBEDA¿
Conditions
Interventions
  • Drug: EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush
  • Drug: EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole
Sponsor
Pfizer
Start date
2010-04
Primary completion
2011-03
Sex
All
Age range
from 21 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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). Exclusion Criteria: * 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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01100437