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

Last updated on May 10, 2018

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

NCT01100437
Pfizer
Terminated
Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients

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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¿
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Chronic Pain
  • 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
  • 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
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.
 
Terminated
14
March 2011
March 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01100437
ALO-01-09-111
B4541002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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