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A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine

Primary Purpose

Chronic Pain

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity
ER Morphine
hydrocodone plus acetaminophen
placebo
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Pain, Opioids

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients with chronic pain for periods greater than 6 months Patients taking greater than 80 mg morphine equivalents of a short acting opioid (>8 vicodin or 4 oxycodone/day) Referral to Pain or Substance Abuse Clinic for self-escalation of opioids Exclusion Criteria: Inability to understand and comprehend spoken English Patients with Munchausen's syndrome Patient has a history of Peripheral Vascular Disease Patient has a history of Raynaud's Phenomenon Liver Disease; Child's classification greater than 1 (liver cirrhosis) will be excluded Renal disease (BUN >25 or Cr >1.5) Congestive Heart Failure; Subjects with New York Heart Association (NYHA)Heart Failure Symptom Classification System Level of Impairment II, III and IV will be excluded Coronary artery disease; recent MI within the past six months or recent history of angina not controlled with NTG within the past six months Hypertension; 1)previously normotensive subject; systolic bp >140 mm Hg and diastolic bp > 90 mm Hg 2) Hx of active treatment with antihypertensive medications; systolic bp >150 mm Hg and diastolic bp > 100 mm Hg Cerebrovascular disease; recent history within the past year of a transient ischemic attack or recent history within the past year of a cerebrovascular event Malignancy requiring active treatment Patient is pregnant (as ascertained by a self-report and a mandatory commercial pregnancy test before any study medication is consumed)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    extended-release morphine

    hydrocodone

    placebo

    Arm Description

    Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity On one of three study dates, subjects received ER morphine tablets, 45 mg (Mallinckrodt Pharmaceuticals, St. Louis, MO). The dose of ER morphine sulfate (45 mg) was selected because of its approximate equianalgesic effect to the dose of hydrocodone-acetaminophen (30/925 mg).

    Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity On the day of the study session, patients received hydrocodone 30 mg plus N-acetyl-para-aminophenol 975 mg (APAP;Qualitest Pharmaceuticals Inc, Huntsville, AL).

    Subjects received a placebo pill if randomized to this arm. Both opioid medications and the placebo were administered in identical capsules.

    Outcomes

    Primary Outcome Measures

    3 Scores on the Addiction Research Center Inventory (ARCI)
    The subjective effects of the study drug were evaluated with 3 subscales of the Addiction Research Center Inventory (ARCI). The subscales studied included Morphine-Benzedrine Group which measured euphoria (0-16 with higher numbers indicating more euphoria), the Phenobarbital-Chorpromazine-Alcohol Group which measured sedation (-3 to +11 with higher scores indicating more sedation), and the Lysergic Acid Diethylmide Group which measured dysphoria and agitation (-4 to +10 with higher scores indicating more dysphoria). This inventory consists of 49 true/ false questions which survey major domains of drug effects. The ARCI was measured at six timepoints. Of interest were trough sedation, peak euphoria, and trough dysphoria.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 11, 2006
    Last Updated
    May 25, 2017
    Sponsor
    University of California, Davis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00314340
    Brief Title
    A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine
    Official Title
    A CTSC Clinical Research Center Study: A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2005 (undefined)
    Primary Completion Date
    April 2008 (Actual)
    Study Completion Date
    April 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, Davis

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Characterize the relative abuse liability of a short versus a long acting opioid in chronic pain patients.
    Detailed Description
    A placebo-controlled, double-blind, crossover trial will be conducted providing study subjects either hydrocodone/acetaminophen 30mg/975mg, sustained release morphine 45mg or placebo on separate GCRC visits. A long acting comparator (slow-release morphine sulfate 45 mg) will be chosen because of its putative equianalgesic effects to the dose of hydrocodone (30 mg) selected. Subjects will participate in the three sessions at the UC Davis/Mather Medical Center General Clinical Research Center (GCRC) at intervals of 7-10 days. Sessions will be approximately 360 min in duration. Subjects will receive either hydrocodone/acetaminophen or sustained release morphine around-the-clock for 7-10 days prior to the experimental session. At each experimental session, an assessment of abuse liability will be completed before the intake of medications, as well as at 0, 60, 120, 180, 240 minutes after the ingestion of the study medication.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain
    Keywords
    Chronic Pain, Opioids

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    extended-release morphine
    Arm Type
    Active Comparator
    Arm Description
    Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity On one of three study dates, subjects received ER morphine tablets, 45 mg (Mallinckrodt Pharmaceuticals, St. Louis, MO). The dose of ER morphine sulfate (45 mg) was selected because of its approximate equianalgesic effect to the dose of hydrocodone-acetaminophen (30/925 mg).
    Arm Title
    hydrocodone
    Arm Type
    Active Comparator
    Arm Description
    Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity On the day of the study session, patients received hydrocodone 30 mg plus N-acetyl-para-aminophenol 975 mg (APAP;Qualitest Pharmaceuticals Inc, Huntsville, AL).
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects received a placebo pill if randomized to this arm. Both opioid medications and the placebo were administered in identical capsules.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity
    Other Intervention Name(s)
    Craving for drugs on 5 visual analog scales, Addiction Research Center, Morphine-Benzedrine Group (euphoria), Phenobarbital-Chorpromazine-Alcohol (sedation), Lysergic Acid Diethylmide (dysphoria, agitation), Benzedrine (an empiric amphetamine scale), Amphetamine (activation), Cue reactivity testing, Neurocognitive testing
    Intervention Description
    The first dose of the study medication was taken following collection of baseline measurements, and subsequent measurements were taken hourly thereafter. Respiration, heart rate, arterial oxygen saturation (pulse oximetry), and blood pressure were also monitored at these intervals to insure the safety of subjects.
    Intervention Type
    Drug
    Intervention Name(s)
    ER Morphine
    Other Intervention Name(s)
    extended release morphine
    Intervention Type
    Drug
    Intervention Name(s)
    hydrocodone plus acetaminophen
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Primary Outcome Measure Information:
    Title
    3 Scores on the Addiction Research Center Inventory (ARCI)
    Description
    The subjective effects of the study drug were evaluated with 3 subscales of the Addiction Research Center Inventory (ARCI). The subscales studied included Morphine-Benzedrine Group which measured euphoria (0-16 with higher numbers indicating more euphoria), the Phenobarbital-Chorpromazine-Alcohol Group which measured sedation (-3 to +11 with higher scores indicating more sedation), and the Lysergic Acid Diethylmide Group which measured dysphoria and agitation (-4 to +10 with higher scores indicating more dysphoria). This inventory consists of 49 true/ false questions which survey major domains of drug effects. The ARCI was measured at six timepoints. Of interest were trough sedation, peak euphoria, and trough dysphoria.
    Time Frame
    0, 60, 120, 180, 240, or 300 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with chronic pain for periods greater than 6 months Patients taking greater than 80 mg morphine equivalents of a short acting opioid (>8 vicodin or 4 oxycodone/day) Referral to Pain or Substance Abuse Clinic for self-escalation of opioids Exclusion Criteria: Inability to understand and comprehend spoken English Patients with Munchausen's syndrome Patient has a history of Peripheral Vascular Disease Patient has a history of Raynaud's Phenomenon Liver Disease; Child's classification greater than 1 (liver cirrhosis) will be excluded Renal disease (BUN >25 or Cr >1.5) Congestive Heart Failure; Subjects with New York Heart Association (NYHA)Heart Failure Symptom Classification System Level of Impairment II, III and IV will be excluded Coronary artery disease; recent MI within the past six months or recent history of angina not controlled with NTG within the past six months Hypertension; 1)previously normotensive subject; systolic bp >140 mm Hg and diastolic bp > 90 mm Hg 2) Hx of active treatment with antihypertensive medications; systolic bp >150 mm Hg and diastolic bp > 100 mm Hg Cerebrovascular disease; recent history within the past year of a transient ischemic attack or recent history within the past year of a cerebrovascular event Malignancy requiring active treatment Patient is pregnant (as ascertained by a self-report and a mandatory commercial pregnancy test before any study medication is consumed)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Barth L Wilsey, MD
    Organizational Affiliation
    University of California, CA Medical Center Division of Pain Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19660492
    Citation
    Wilsey BL, Fishman S, Li CS, Storment J, Albanese A. Markers of abuse liability of short- vs long-acting opioids in chronic pain patients: a randomized cross-over trial. Pharmacol Biochem Behav. 2009 Nov;94(1):98-107. doi: 10.1016/j.pbb.2009.07.014. Epub 2009 Aug 4.
    Results Reference
    result

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    A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine

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