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

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NCT01100437

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Study Location
Lifetree Clinical Research
Salt Lake City, Utah, 84106, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients
Official Title  ICMJE 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¿
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Drug: 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
  • 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
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: EMBEDA? (morphine sulfate/naltrexone hydrochloride) crush
  • Experimental: 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
    Intervention: Drug: EMBEDA? (morphine sulfate/naltrexone hydrochloride) whole
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 29, 2011)		14
Original Estimated Enrollment  ICMJE
 (submitted: April 7, 2010)		80
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01100437
Other Study ID Numbers  ICMJE ALO-01-09-111
B4541002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP