NCT00495404

Brief Summary

Although the use of opioid medications has gained increasing acceptance as a treatment option for chronic pain, there is little empirical research concerning long-term outcomes with this patient population. Several important questions concerning the use of opioids have yet to be examined in controlled studies. These include: determination of the most effective dosing regime, specification of the risk factors for medication abuse, and identification of patients most likely to achieve long-term benefits. Despite the lack of empirical data, the clinical literature to date yields two general approaches to the use of opioid treatment with chronic, nonmalignant pain. The first approach dictates that due to risk of addiction, tolerance, and insensitivity to large doses, opioid medications should be carefully controlled, with minimal and stable dosing as the eventual goal of treatment. The second approach, fostered by the beneficial use of opioids in the treatment of cancer pain, maintains that risk of addiction and abuse has been exaggerated. Proponents of this approach suggest that under-medication is a significant cause of treatment failure and non-compliance in chronic pain patients, and that prescription guidelines should emphasize patients� reports of adequate relief, regardless of dosage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Aug 2001

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 3, 2007

Completed
Last Updated

April 7, 2015

Status Verified

June 1, 2007

First QC Date

June 29, 2007

Last Update Submit

April 6, 2015

Conditions

Chronic PainBehavior, Addictive

Keywords

chronic non-malignant painopiatesprescriptionsaddiction

Outcome Measures

Primary Outcomes (1)

  • Measure: Pain Relief (Visual Analogue Scales of pain variables and relief measures); Measure: Quality of Life (Oswestry Disability Index); Measure: Addictive Behaviors (Prescription Drug Use Questionnaire, Addiction Behaviors Checklist, Reason for Opioid

Secondary Outcomes (1)

  • Medication Use; Stability of Use; Treatment Satisfaction; Mood; Illness Beliefs; Health Care Utilization

Study Arms (2)

Arm 1

OTHER
Behavioral: Physician Treatment Guidelines

Arm 2

OTHER
Behavioral: Physician Treatment Guidelines

Interventions

Physician Treatment GuidelinesBEHAVIORAL
Arm 1Arm 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veteran within Greater Los Angeles Healthcare System; Presence of chronic non-malignant pain for at least 6 months

You may not qualify if:

  • Anticipated surgery within 6 months; Current testing for pain etiology; Serious health conditions (pulmonary disease, congestive heart failure); Active or recent (past 2 years) substance abuse problems; Psychiatric hospitalization within past 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

Related Publications (3)

  • Divono EC, Singh M, Renner SW, Baria AM, Schieffer B, Korobkin S, Naliboff BD. Comparison of opiate test results obtained from the LX20, AxSYM, REMEDi HS and RapidOne Oxy testing systems with prescribed medications. Clinical Chemistry. 2003 May 1; 49(S6):A77.

    RESULT

  • Naliboff BD, Wu SM, Pham Q. Clinical considerations in the treatment of chronic pain with opiates. J Clin Psychol. 2006 Nov;62(11):1397-408. doi: 10.1002/jclp.20319.

    PMID: 16937352RESULT

  • Wu SM, Compton P, Bolus R, Schieffer B, Pham Q, Baria A, Van Vort W, Davis F, Shekelle P, Naliboff BD. The addiction behaviors checklist: validation of a new clinician-based measure of inappropriate opioid use in chronic pain. J Pain Symptom Manage. 2006 Oct;32(4):342-51. doi: 10.1016/j.jpainsymman.2006.05.010.

    PMID: 17000351RESULT

MeSH Terms

Conditions

Chronic PainBehavior, Addictive

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Bruce D Naliboff, PhD MA

    VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2007

First Posted

July 3, 2007

Study Start

August 1, 2001

Study Completion

March 1, 2005

Last Updated

April 7, 2015

Record last verified: 2007-06

Locations

US(1)