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Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients | Clinical Trials | Clareo Health

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

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¿

NCT01100437•Pfizer

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Lifetree Clinical Research

Salt Lake City, Utah, United States

Key Dates

Start Date

April 1, 2010

Primary Completion Date

March 1, 2011

Completion Date

March 1, 2011

Last Updated

July 13, 2012

Enrollment

ACTUAL participants

Conditions

Chronic Pain

Interventions

EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush

DRUG

EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 13, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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