Status:
COMPLETED
A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine
Lead Sponsor:
University of California, Davis
Conditions:
Chronic Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00314340
Start Date
November 1 2005
End Date
April 1 2008
Last Update
May 30 2017
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