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A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine

Information source: University of California, Davis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Pain

Intervention: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity (Behavioral); ER Morphine (Drug); hydrocodone plus acetaminophen (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

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

Characterize the relative abuse liability of a short versus a long acting opioid in chronic pain patients.

Clinical Details

Official title: A CTSC Clinical Research Center Study: A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: 3 Scores on the Addiction Research Center Inventory (ARCI)

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

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

Additional Information

Starting date: November 2005
Last updated: July 11, 2013

Page last updated: August 23, 2015

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