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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314340
• Other study ID #: 200513430
• Status: Completed
• Phase: Phase 4
• First received: April 11, 2006
• Last updated: May 25, 2017
• Start date: November 2005
• Est. completion date: April 2008

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity
The first dose of the study medication was taken following collection of baseline measurements, and subsequent measurements were taken hourly thereafter. Respiration, heart rate, arterial oxygen saturation (pulse oximetry), and blood pressure were also monitored at these intervals to insure the safety of subjects.

Drug:
• ER Morphine

• hydrocodone plus acetaminophen

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 Scores on the Addiction Research Center Inventory (ARCI)	The subjective effects of the study drug were evaluated with 3 subscales of the Addiction Research Center Inventory (ARCI). The subscales studied included Morphine-Benzedrine Group which measured euphoria (0-16 with higher numbers indicating more euphoria), the Phenobarbital-Chorpromazine-Alcohol Group which measured sedation (-3 to +11 with higher scores indicating more sedation), and the Lysergic Acid Diethylmide Group which measured dysphoria and agitation (-4 to +10 with higher scores indicating more dysphoria). This inventory consists of 49 true/ false questions which survey major domains of drug effects. The ARCI was measured at six timepoints. Of interest were trough sedation, peak euphoria, and trough dysphoria.	0, 60, 120, 180, 240, or 300 minutes