Chronic PainPhase 4NCT00314340
A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine
A Phase 4 study testing Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity, ER Morphine and hydrocodone plus acetaminophen in people with Chronic Pain, run by University of California, Davis.
Trial summary
Characterize the relative abuse liability of a short versus a long acting opioid in chronic pain patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity, ER Morphine and hydrocodone plus acetaminophen
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Apr 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
About this study
Official title: A CTSC Clinical Research Center Study: A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine
Characterize the relative abuse liability of a short versus a long acting opioid in chronic pain patients.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity, ER Morphine, hydrocodone plus acetaminophen, placebo
- Keywords
- Chronic Pain, Opioids
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Markers of Abuse Liability, Neuropsych Testing, and Cue ReactivityBehavioural
Also called Craving for drugs on 5 visual analog scales, Addiction Research Center, Morphine-Benzedrine Group (euphoria), Phenobarbital-Chorpromazine-Alcohol (sedation)
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.
ER MorphineDrug
Also called extended release morphine
hydrocodone plus acetaminophenDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. Receives: Behavioral: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 60, 120, 180, 240, or 300 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2006 (estimated)
- Study startNov 2005
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barth L Wilsey, MD, Principal investigator, University of California, CA Medical Center Division of Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314340
- Sponsor's protocol ID
- 200513430
- Status last verified
- May 2017
- First submitted
- 11 Apr 2006
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 19660492
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A CTSC Clinical Research Center Study: A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine
- ClinicalTrials.gov ID
- NCT00314340
- Acronym / sponsor ID
- 200513430
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, Opioids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 13 Apr 2006 (estimated)
- Results
- Posted 12 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| extended-release morphine | Active comparator | Behavioral: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity, Drug: ER MorphineMarkers 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). |
| hydrocodone | Active comparator | Behavioral: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity, Drug: hydrocodone plus acetaminophenMarkers 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). |
| placebo | Placebo comparator | Behavioral: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity, Drug: placeboSubjects received a placebo pill if randomized to this arm. Both opioid medications and the placebo were administered in identical capsules. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Markers of Abuse Liability, Neuropsych Testing, and Cue ReactivityAlso: Craving for drugs on 5 visual analog scales, Addiction Research Center, Morphine-Benzedrine Group (euphoria), Phenobarbital-Chorpromazine-Alcohol (sedation)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. | Behavioural | extended-release morphine, hydrocodone, placebo |
| ER MorphineAlso: extended release morphine | Drug | extended-release morphine |
| hydrocodone plus acetaminophen | Drug | hydrocodone |
| placebo | Drug | placebo |
Primary outcome
3 Scores on the Addiction Research Center Inventory (ARCI)
Time frame: 0, 60, 120, 180, 240, or 300 minutes
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19660492Wilsey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barth L Wilsey, MD principal investigator
University of California, CA Medical Center Division of Pain Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity, ER Morphine and hydrocodone plus acetaminophen in people with Chronic Pain, run by University of California, Davis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 Scores on the Addiction Research Center Inventory (ARCI) (time frame: 0, 60, 120, 180, 240, or 300 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00314340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.