A CCRC Study: A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine
Information source: University of California, Davis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Pain
Intervention: Slow Release Morphine (drug) (Drug); Hydrocodone (Drug); Placebo (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: University of California, Davis Official(s) and/or principal investigator(s):
Barth L Wilsey, MD, Principal Investigator, Affiliation: University of California, CA Medical Center Division of Pain Medicine
Summary
1. Characterize the relative abuse liability of a short versus a long acting opioid in
chronic pain patients.
2. Demonstrate that opioid-induced hyperalgesia differs among prescription opioids.
3. Demonstrate the feasibility of using cue-reactivity to study the abuse potential of
prescription opioids.
Clinical Details
Official title: A CTSC Clinical Research Center Study: A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Demonstrate that opioid-induced hyperalgesia differs among prescription opioids.Demonstrate the feasibility of using cue-reactivity to study the abuse potential of prescription opioids. Characterizing 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, 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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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)
Locations and Contacts
UCDMC/VANCHCS General Clinical Research Center, Mather, California 95655, United States
Additional Information
Starting date: November 2005
Ending date: April 2008
Last updated: December 6, 2007
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