Clinical trial NCT00314340: A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine
Official title: A CTSC Clinical Research Center Study: A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Pain
Keywords: Chronic Pain
Opioids
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2006-04-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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 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)

Primary outcomes:
measure: 3 Scores on the Addiction Research Center Inventory (ARCI)
timeFrame: 0, 60, 120, 180, 240, or 300 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, CA Medical Center Division of Pain Medicine
name: Barth L Wilsey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilsey BL, Fishman S, Li CS, Storment J, Albanese A. Markers of abuse liability of short- vs long-acting opioids in chronic pain patients: a randomized cross-over trial. Pharmacol Biochem Behav. 2009 Nov;94(1):98-107. doi: 10.1016/j.pbb.2009.07.014. Epub 2009 Aug 4.