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Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users

Last updated on December 6, 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.
Episodic Nondependent Opioid Abuse
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

- Subject is a recreational opioid user who is NOT physically 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 recreationally abusing 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 prior to Visit 1.

- Subject is in generally good health as determined by medical history, physical
examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram
(ECG).

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

- Has a history or current diagnosis of substance 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).

- History or presence of any clinically significant illness (e.g., cardiovascular,
pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic,
dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other
condition, which in the opinion of the Investigator would jeopardize the safety of the
subject or the validity of the study results.

- Has a known allergy or history of hypersensitivity to morphine sulfate, opioids in
general, naltrexone hydrochloride (HCl) or similar compounds and/or the known
excipients in the investigational drug products.

- 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).

- Females who are pregnant, lactating, or are planning to become pregnant during the
course of the study. Females with a positive serum pregnancy test at Visit 1 or at any
subsequent study visit will be excluded from participating in the study.

NCT01380093
Pfizer
Completed
Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users

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Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users
A Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Way Crossover Study to Determine the Abuse Potential of Oral Administration of Crushed EMBEDA Relative to Crushed Controlled-Release Morphine Sulfate and Placebo in Non Dependent, Recreational Opioid Users
The primary purpose of this study is to determine the abuse potential of EMBEDA compared to controlled release morphine when crushed and taken orally by non-dependent recreational opioid users; secondary purposes include to determine the abuse potential of crushed EMBEDA relative to placebo and and to compare the pharmacokinetics and safety of crushed EMBEDA with crushed controlled-release morphine and crushed placebo.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Nondependent Opioid Abuse, Episodic
  • Drug: Placebo
    Single-dose, 2 x microcrystalline cellulose (weighed to equal weights of average tablet/capsule of active comparator) mixed with 150 ml artificially sweetened, non-carbonated beverage
  • Drug: MS Contin (morphine sulfate, controlled release)
    Single-dose, 2 x 60 mg morphine sulfate whole tablets manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage
  • Drug: EMBEDA (morphine sulfate / naltrexone hydrochloride)
    Single-dose, solution 2 x 60 mg morphine sulfate with sequestered 2.4 mg Naltrexone hydrochloride whole capsules manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: MS Contin (morphine sulfate, controlled release)
    Intervention: Drug: MS Contin (morphine sulfate, controlled release)
  • Experimental: EMBEDA (morphine sulfate / naltrexone hydrochloride)
    Intervention: Drug: EMBEDA (morphine sulfate / naltrexone hydrochloride)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
May 2011
May 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is a recreational opioid user who is NOT physically 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 recreationally abusing 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 prior to Visit 1.
  • Subject is in generally good health as determined by medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

  • Has a history or current diagnosis of substance 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).
  • History or presence of any clinically significant illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other condition, which in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
  • Has a known allergy or history of hypersensitivity to morphine sulfate, opioids in general, naltrexone hydrochloride (HCl) or similar compounds and/or the known excipients in the investigational drug products.
  • 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).
  • Females who are pregnant, lactating, or are planning to become pregnant during the course of the study. Females with a positive serum pregnancy test at Visit 1 or at any subsequent study visit will be excluded from participating in the study.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01380093
ALO-01-10-4005
B4541003
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2011

ICMJE     Data element required by the

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

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