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

NCT00314340 | Completed Phase 4 Results

• 1 other identifier: 200513430
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Pain

Keywords

Chronic Pain; Opioids

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

extended-release morphine

ACTIVE COMPARATOR

Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity On one of three study dates, subjects received ER morphine tablets, 45 mg (Mallinckrodt Pharmaceuticals, St. Louis, MO). The dose of ER morphine sulfate (45 mg) was selected because of its approximate equianalgesic effect to the dose of hydrocodone-acetaminophen (30/925 mg).

Behavioral: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity; Drug: ER Morphine

hydrocodone

ACTIVE COMPARATOR

Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity On the day of the study session, patients received hydrocodone 30 mg plus N-acetyl-para-aminophenol 975 mg (APAP;Qualitest Pharmaceuticals Inc, Huntsville, AL).

Behavioral: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity; Drug: hydrocodone plus acetaminophen

placebo

PLACEBO COMPARATOR

Subjects received a placebo pill if randomized to this arm. Both opioid medications and the placebo were administered in identical capsules.

Behavioral: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity; Drug: placebo

Interventions

Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity BEHAVIORAL

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.

Also known as: Craving for drugs on 5 visual analog scales, Addiction Research Center, Morphine-Benzedrine Group (euphoria), Phenobarbital-Chorpromazine-Alcohol (sedation), Lysergic Acid Diethylmide (dysphoria, agitation), Benzedrine (an empiric amphetamine scale), Amphetamine (activation), Cue reactivity testing, Neurocognitive testing

extended-release morphine; hydrocodone; placebo

ER Morphine DRUG

Also known as: extended release morphine

extended-release morphine

hydrocodone plus acetaminophen DRUG

hydrocodone

placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Davis: lead

Related 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 2009 Aug 4.

  PMID: 19660492 RESULT

MeSH Terms

Conditions

Chronic Pain

Interventions

Ethanol; benzedrine; Amphetamine; Hydrocodone; Acetaminophen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Amphetamines; Phenethylamines; Ethylamines; Amines; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds

Results Point of Contact

• Title: Barth Wilsey MD
• Organization: UC Davis Medical Center

blwilsey@ucdavis.edu

916-843-7165

Study Officials

• Barth L Wilsey, MD

  University of California, CA Medical Center Division of Pain Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2006
• First Posted: April 13, 2006
• Study Start: November 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 30, 2017
• Results First Posted: July 12, 2013

Record last verified: 2017-05