A CCRC Study: A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine
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Purpose
- Characterize the relative abuse liability of a short versus a long acting opioid in chronic pain patients.
- Demonstrate that opioid-induced hyperalgesia differs among prescription opioids.
- Demonstrate the feasibility of using cue-reactivity to study the abuse potential of prescription opioids.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Pain |
Drug: Slow Release Morphine (drug) Drug: Hydrocodone 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 |
- Demonstrate that opioid-induced hyperalgesia differs among prescription opioids. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Demonstrate the feasibility of using cue-reactivity to study the abuse potential of prescription opioids. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Characterizing the relative abuse liability of a short versus a long acting opioid in chronic pain patients [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| 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: Hydrocodone
On the day of the study session, subjects received hydrocodone 30 mg plus N-acetyl-para-aminophenol 975 mg (APAP; Qualitest Pharmaceuticals Inc, Huntsville, AL
|
Drug: Slow Release Morphine (drug)
Slow Release Morphine treatment for days 1-3 of the week prior to the study visit: 1 SR morphine pill 4 times per day from Vial A1 (60mg total), 1-2 sugar pills from Vial B as needed for breakthrough-pain Slow Release Morphine treatment for days 4-10 of the week prior to the study visit: 1 SR morphine pill every 8 hrs from Vial A2 (90mg total), 1 sugar pill from Vial B 4 hours after each dose from Vial A2 Slow Release Morphine treatment during the study visit: 3 Morphine pills (45mg total) |
|
Active Comparator: ER Morphine
On the day of the study session, patients received ER morphine tablets, 45 mg (Mallinckrodt Pharmaceuticals, St. Louis, MO. ), or placebo. The dose of ER morphine sulfate (45 mg) was selected because of its approximate equianalgesic effect (Max et al., 1999) to the dose of hydrocodone-acetaminophen (30/925 mg).
|
Drug: Hydrocodone
Hydrocodone treatment for days 1-3 of the week prior to the study visit: 1 hydrocodone/acetaminophen pill 4 times per day from Vial A1 (40/1300mg total), 1-2 hydrocodone/acetaminophen pills from Vial B as needed for break-through pain Hydrocodone treatment for days 4-10 of the week prior to the study visit: 1 hydrocodone/acetaminophen pill every 8 hrs from Vial A2 (30/975mg total), 1 hydrocodone/acetaminophen pill from Vial B 4 hours after each dose from Vial A2 (30/975mg total) Hydrocodone treatment during the study visit: 3 hydrocodone/acetaminophen (30/975mg total) |
|
Placebo Comparator: Placebo
Both opioid medications and the placebo were administered in identical capsules.
|
Drug: Placebo
Placebo treatment for days 1-3 of the week prior to the study visit: 1 hydrocodone/acetaminophen pill 4 times per day from Vial A1 (40/1300mg total), 1-2 hydrocodone/acetaminophen pills from Vial B as needed for break-through pain Placebo treatment for days 4-10 of the week prior to the study visit: 1 hydrocodone/acetaminophen pill every 8 hrs from Vial A2 (30/975mg total), 1 hydrocodone/acetaminophen pill from Vial B 4 hours after each dose from Vial A2 (30/975mg total) Placebo treatment during the study visit: 3 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, the following tests 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: assessment of abuse liability, mood affects, withdrawal symptoms, opioid serum levels (pre-dose, 80 and 210 minutes post-dose), pain assessment, cognitive testing, cold-pressor testing for opioid-induced hyperalgesia, and cue-reactivity.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| United States, California | |
| UCDMC/VANCHCS General Clinical Research Center | |
| Mather, California, United States, 95655 | |
| Principal Investigator: | Barth L Wilsey, MD | University of California, CA Medical Center Division of Pain Medicine |
More Information
No publications provided
| 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 |
| Last Updated: | November 15, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of California, Davis:
|
Chronic Pain Opioids |
Additional relevant MeSH terms:
|
Acetaminophen Hydrocodone Morphine Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Analgesics, Opioid Central Nervous System Depressants Antitussive Agents Respiratory System Agents Narcotics |
ClinicalTrials.gov processed this record on May 19, 2013