A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine
This study has been completed.
Sponsor:
University of California, Davis
Information provided by (Responsible Party):
Barth Wilsey, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00314340
First received: April 11, 2006
Last updated: July 11, 2013
Last verified: July 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
Characterize the relative abuse liability of a short versus a long acting opioid in chronic pain patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Pain |
Behavioral: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity Drug: ER Morphine Drug: hydrocodone plus acetaminophen Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A CTSC Clinical Research Center Study: A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine |
Resource links provided by NLM:
MedlinePlus related topics:
Chronic Pain
Drug Information available for:
Phenobarbital
Amphetamine sulfate
Morphine sulfate
Acetaminophen
Hydrocodone
Hydrocodone bitartrate
Amphetamine
Hycodan
U.S. FDA Resources
Further study details as provided by University of California, Davis:
Primary Outcome Measures:
- 3 Scores on the Addiction Research Center Inventory (ARCI) [ Time Frame: 0, 60, 120, 180, 240, or 300 minutes ] [ Designated as safety issue: No ]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.
| Enrollment: | 12 |
| Study Start Date: | November 2005 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
|
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
|
|
Placebo Comparator: placebo
Subjects received a placebo pill if randomized to this arm. Both opioid medications and the placebo were administered in identical capsules.
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314340
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Publications:
| Responsible Party: | Barth Wilsey, Research Professor, University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00314340 History of Changes |
| Other Study ID Numbers: | 200513430 |
| Study First Received: | April 11, 2006 |
| Results First Received: | November 20, 2012 |
| Last Updated: | July 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of California, Davis:
|
Chronic Pain Opioids |
Additional relevant MeSH terms:
|
Chronic Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Acetaminophen Morphine Hydrocodone Phenobarbital Amphetamine Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Antipyretics Analgesics, Opioid Narcotics Central Nervous System Depressants Anticonvulsants Hypnotics and Sedatives Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action GABA Modulators GABA Agents Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers |
ClinicalTrials.gov processed this record on September 30, 2016