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Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Narcotic Abuse, Opioid-related Disorders, Analgesia, Chronic Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male or female subjects 18 to 55 years of age, inclusive.

- Subject is a recreational opioid user who is NOT dependent on opioids based on
Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision
(DSM-IV-TR) criteria and the Naloxone Challenge. A recreational opioid user is defined
as use of opioids for non-therapeutic purposes (i.e., for psychoactive effects) on at
least 10 occasions within the last year and at least once in the 12 weeks before the
Screening Visit (Visit 1).

- Subjects must have experience with intranasal drug administration, defined as
intranasal use on at least 3 occasions within the last year prior to the Screening
Visit.

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

- Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine), as
assessed by the Investigator using the DSM IV-TR criteria.

- Has participated in, is currently participating in, or is seeking treatment for
substance- and or alcohol-related disorders (excluding nicotine and caffeine).

- Has any condition in which an opioid is contraindicated; e.g., significant respiratory
depression, acute or severe bronchial asthma or hypercarbia, or is suspected of having
paralytic ileus.

- Allergy or history of hypersensitivity to morphine sulfate, other opioids, naltrexone
hydrochloride, naloxone, and/or lactose.

- History or current clinically significant neurological, cardiovascular, renal,
hepatic, endocrine, gastrointestinal, hematologic, or metabolic disease as evaluated
by the Investigator.

- History or current pulmonary disease including asthma, chronic obstructive pulmonary
disease, exercise-induced asthma, bronchitis, and obstructive sleep apnea.

NCT01595867
Pfizer
Completed
Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo

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Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo
A Randomized, Double-Blind, Placebo-Controlled, 3 Way Crossover Study Evaluating The Relative Abuse Potential Of Crushed Embeda Compared To Morphine Sulfate Controlled Release Tablets (Crushed) And Placebo In Non-Dependent, Recreational Opioid Users Following Intranasal Administration
This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational opioid users. An appropriate dose of morphine sulfate CR (i.e., 30 mg, 60 or 90 mg) was to be selected during Part A of the study (Dose Selection Phase). Each subject participated in the study for up to (approximately) 16 weeks and was confined in the clinic for a total of up to 12 nights.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
  • Narcotic Abuse
  • Opioid-related Disorders
  • Analgesia
  • Chronic Pain
  • Drug: Placebo
    Lactose (100 mg) placebo tablets crushed; single dose
  • Drug: EMBEDA - morphine sulfate/ naltrexone hydrochloride
    EMBEDA (morphine sulfate/naltrexone hydrochloride) 30 mg/ 1.2 mg extended release; capsule contents crushed; single dose
  • Drug: morphine sulfate CR crushed.
    Morphine sulfate controlled release 30 mg tablet crushed
  • Placebo Comparator: Treatment A
    Placebo
    Intervention: Drug: Placebo
  • Experimental: Treatment B
    EMBEDA 30 mg crushed
    Intervention: Drug: EMBEDA - morphine sulfate/ naltrexone hydrochloride
  • Active Comparator: Treatment C
    Morphine Sulfate Controlled Release 30 mg crushed
    Intervention: Drug: morphine sulfate CR crushed.
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
January 2011
January 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male or female subjects 18 to 55 years of age, inclusive.
  • Subject is a recreational opioid user who is NOT dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria and the Naloxone Challenge. A recreational opioid user is defined as use of opioids for non-therapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks before the Screening Visit (Visit 1).
  • Subjects must have experience with intranasal drug administration, defined as intranasal use on at least 3 occasions within the last year prior to the Screening Visit.

Exclusion Criteria:

  • Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine), as assessed by the Investigator using the DSM IV-TR criteria.
  • Has participated in, is currently participating in, or is seeking treatment for substance- and or alcohol-related disorders (excluding nicotine and caffeine).
  • Has any condition in which an opioid is contraindicated; e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or is suspected of having paralytic ileus.
  • Allergy or history of hypersensitivity to morphine sulfate, other opioids, naltrexone hydrochloride, naloxone, and/or lactose.
  • History or current clinically significant neurological, cardiovascular, renal, hepatic, endocrine, gastrointestinal, hematologic, or metabolic disease as evaluated by the Investigator.
  • History or current pulmonary disease including asthma, chronic obstructive pulmonary disease, exercise-induced asthma, bronchitis, and obstructive sleep apnea.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01595867
ALO-01-10-4004
B4541005
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

ICMJE     Data element required by the

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

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