A CCRC Study: A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine - Full Text View

Sponsor:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00314340

Purpose

Characterize the relative abuse liability of a short versus a long acting opioid in chronic pain patients.
Demonstrate that opioid-induced hyperalgesia differs among prescription opioids.
Demonstrate the feasibility of using cue-reactivity to study the abuse potential of prescription opioids.

Condition	Intervention	Phase
Chronic Pain	Drug: Slow Release Morphine (drug) Drug: Hydrocodone Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	A CTSC Clinical Research Center Study: A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine

Resource links provided by NLM:

Drug Information available for: Hydrocodone Hydrocodone bitartrate Hycodan

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

Demonstrate that opioid-induced hyperalgesia differs among prescription opioids. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Demonstrate the feasibility of using cue-reactivity to study the abuse potential of prescription opioids. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Characterizing the relative abuse liability of a short versus a long acting opioid in chronic pain patients [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	November 2005
Estimated Study Completion Date:	April 2008

Arms	Assigned Interventions
1: Active Comparator	Drug: Slow Release Morphine (drug) Slow Release Morphine treatment for days 1-3 of the week prior to the study visit: 1 SR morphine pill 4 times per day from Vial A1 (60mg total), 1-2 sugar pills from Vial B as needed for breakthrough-pain Slow Release Morphine treatment for days 4-10 of the week prior to the study visit: 1 SR morphine pill every 8 hrs from Vial A2 (90mg total), 1 sugar pill from Vial B 4 hours after each dose from Vial A2 Slow Release Morphine treatment during the study visit: 3 Morphine pills (45mg total)
2: Active Comparator	Drug: Hydrocodone Hydrocodone treatment for days 1-3 of the week prior to the study visit: 1 hydrocodone/acetaminophen pill 4 times per day from Vial A1 (40/1300mg total), 1-2 hydrocodone/acetaminophen pills from Vial B as needed for break-through pain Hydrocodone treatment for days 4-10 of the week prior to the study visit: 1 hydrocodone/acetaminophen pill every 8 hrs from Vial A2 (30/975mg total), 1 hydrocodone/acetaminophen pill from Vial B 4 hours after each dose from Vial A2 (30/975mg total) Hydrocodone treatment during the study visit: 3 hydrocodone/acetaminophen (30/975mg total)
3: Placebo Comparator	Drug: Placebo Placebo treatment for days 1-3 of the week prior to the study visit: 1 hydrocodone/acetaminophen pill 4 times per day from Vial A1 (40/1300mg total), 1-2 hydrocodone/acetaminophen pills from Vial B as needed for break-through pain Placebo treatment for days 4-10 of the week prior to the study visit: 1 hydrocodone/acetaminophen pill every 8 hrs from Vial A2 (30/975mg total), 1 hydrocodone/acetaminophen pill from Vial B 4 hours after each dose from Vial A2 (30/975mg total) Placebo treatment during the study visit: 3 Placebo

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314340

Locations

United States, California
UCDMC/VANCHCS General Clinical Research Center
Mather, California, United States, 95655

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator:

Barth L Wilsey, MD

University of California, CA Medical Center Division of Pain Medicine

More Information

No publications provided

Responsible Party:	University of California, Davis ( Barth Wilsey, MD )
Study ID Numbers:	200513430
Study First Received:	April 11, 2006
Last Updated:	December 6, 2007
ClinicalTrials.gov Identifier:	NCT00314340 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Davis:

Chronic Pain
Opioids

Additional relevant MeSH terms:

Morphine
Respiratory System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Sensory System Agents

Therapeutic Uses
Hydrocodone
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010