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

NCT ID: NCT01100437

Last Updated: 2012-07-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-03-31

Brief 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.

Conditions

Chronic Pain

Keywords

opioid; morphine; naltrexone; withdrawal signs; withdrawal symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: TRIPLE

Study Groups

EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush

EMBEDA (morphine sulfate plus naltrexone hydrochloride ER) capsules crushed and mixed in solution and administered orally at each patient's stable dose, given either once daily or twice daily.

Group Type: EXPERIMENTAL

EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush

Intervention Type: DRUG

Placebo capsules plus EMBEDA capsules crushed and mixed in solution administered orally at each patient's stable dose, given either once daily or twice daily

EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole

EMBEDA (morphine sulfate plus naltrexone hydrochloride ER) capsules, administered orally and intact at each patient's stable dose, given either once daily or twice daily

Group Type: EXPERIMENTAL

EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole

Intervention Type: DRUG

EMBEDA capsules, administered orally and intact at each patient's stable dose, given either once daily or twice daily with 150mL placebo solution

Interventions

EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush

Placebo capsules plus EMBEDA capsules crushed and mixed in solution administered orally at each patient's stable dose, given either once daily or twice daily

Intervention Type: DRUG

EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole

EMBEDA capsules, administered orally and intact at each patient's stable dose, given either once daily or twice daily with 150mL placebo solution

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Lifetree Clinical Research

Salt Lake City, Utah, United States

Countries

United States

References

Setnik B, Roland CL, Goli V, Sommerville K, Webster L. A clinical trial to determine if corelease of morphine and naltrexone from crushed extended-release capsules induces withdrawal in opioid-dependent patients: a descriptive analysis of six patients. J Opioid Manag. 2013 Mar-Apr;9(2):139-50. doi: 10.5055/jom.2013.0155.

Reference Type: DERIVED

PMID: 23709323 (View on PubMed)

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=ALO-01-09-111&StudyName=Safety%20Study%20to%20Assess%20Opiate%20Withdrawal%20Signs%20and%20Symptoms%20in%20Opioid%20Dependent%20Patients

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Other Identifiers

B4541002

Identifier Type: -

Identifier Source: secondary_id

ALO-01-09-111

Identifier Type: -

Identifier Source: org_study_id