Phase 4
N=12
A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT00314340 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: 3 Scores on the Addiction Research Center Inventory (ARCI) — 7.6; 5.4; 5.2; 3.3 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity (Behavioral); ER Morphine (Drug); hydrocodone plus acetaminophen (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Davis
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 3 Scores on the Addiction Research Center Inventory (ARCI) |
7.6; 5.4; 5.2; 3.3; 4.6; 3.5 | — |
Summary
Characterize the relative abuse liability of a short versus a long acting opioid in chronic pain patients.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00314340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.