A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine
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| ClinicalTrials.gov Identifier: NCT00314340 |
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Recruitment Status :
Completed
First Posted : April 13, 2006
Results First Posted : July 12, 2013
Last Update Posted : May 30, 2017
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Sponsor:
University of California, Davis
Information provided by (Responsible Party):
University of California, Davis
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Brief Summary:
Characterize the relative abuse liability of a short versus a long acting opioid in chronic pain patients.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Pain | Behavioral: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity Drug: ER Morphine Drug: hydrocodone plus acetaminophen Drug: placebo | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 12 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A CTSC Clinical Research Center Study: A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine |
| Study Start Date : | November 2005 |
| Actual Primary Completion Date : | April 2008 |
| Actual Study Completion Date : | April 2008 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Chronic Pain
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: extended-release morphine
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). |
Behavioral: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity
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.
Other Names:
Drug: ER Morphine
Other Name: extended release morphine
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Active Comparator: hydrocodone
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). |
Behavioral: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity
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.
Other Names:
Drug: hydrocodone plus acetaminophen
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Placebo Comparator: placebo
Subjects received a placebo pill if randomized to this arm. Both opioid medications and the placebo were administered in identical capsules.
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Behavioral: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity
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.
Other Names:
Drug: placebo
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Primary Outcome Measures :
- 3 Scores on the Addiction Research Center Inventory (ARCI) [ Time Frame: 0, 60, 120, 180, 240, or 300 minutes ]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.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314340
Sponsors and Collaborators
University of California, Davis
Investigators
| Principal Investigator: | Barth L Wilsey, MD | University of California, CA Medical Center Division of Pain Medicine |
Publications of Results:
| Responsible Party: | University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00314340 History of Changes |
| Other Study ID Numbers: |
200513430 |
| First Posted: | April 13, 2006 Key Record Dates |
| Results First Posted: | July 12, 2013 |
| Last Update Posted: | May 30, 2017 |
| Last Verified: | May 2017 |
Keywords provided by University of California, Davis:
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Chronic Pain Opioids |
Additional relevant MeSH terms:
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Chronic Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Morphine Hydrocodone Acetaminophen Amphetamine Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents |
Peripheral Nervous System Agents Analgesics, Non-Narcotic Antipyretics Antitussive Agents Respiratory System Agents Central Nervous System Stimulants Sympathomimetics Autonomic Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators |