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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 November 8, 2019

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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Descriptive Information
Brief Title  ICMJE Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Nondependent Opioid Abuse, Episodic
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
Publications *Setnik B, Sommerville K, Goli V, Han L, Webster L. Assessment of pharmacodynamic effects following oral administration of crushed morphine sulfate and naltrexone hydrochloride extended-release capsules compared with crushed morphine sulfate controlled-release tablets and placebo in nondependent recreational opioid users. Pain Med. 2013 Aug;14(8):1173-86. doi: 10.1111/pme.12148. Epub 2013 Jun 7.


*   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 Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2012)
80
Original Actual Enrollment  ICMJE
 (submitted: June 23, 2011)
36
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion DateMay 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT01380093
Other Study ID Numbers  ICMJE ALO-01-10-4005
B4541003
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2011

ICMJE     Data element required by the

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

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

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1-800-718-1021

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