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Substance Abuse Treatment for High Risk Chronic Pain Patients on Opioid Therapy

Primary Purpose

Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cognitive behavioral training
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring pain, opioids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • chronic pain for >6 months
  • history of taking daily opioids for pain for >6 months
  • average >3 on a pain intensity scale of 0 to 10 over past week
  • able to speak and understand English
  • chronic neck or back pain as primary pain complaint
  • willingness to participate

Exclusion Criteria:

  • current opioid addiction (M.I.N.I. Section K)
  • current diagnosis of cancer or any other malignant disease
  • acute osteomyelitis or acute bone disease
  • nonambulatory
  • present or past DSM-IV diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder
  • pregnancy
  • any clinically unstable systemic illness judged to interfere with treatment
  • an acute condition requiring surgery
  • taking opioids intermittently

Sites / Locations

  • Brigham and Women's Hospital Pain Management Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

High-Risk No Treatment

High-Risk Treatment

Low-Risk

Arm Description

Outcomes

Primary Outcome Measures

Drug Misuse Index: 1) physician ratings of misuse (ABC), 2) structured self-report interview (PDUQ), and 3) urine tox screens

Secondary Outcome Measures

1) Rate of patient dismissal from a pain center, 2) treatment satisfaction ratings

Full Information

First Posted
September 30, 2009
Last Updated
June 22, 2011
Sponsor
Brigham and Women's Hospital
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00988962
Brief Title
Substance Abuse Treatment for High Risk Chronic Pain Patients on Opioid Therapy
Official Title
Substance Abuse Treatment for High Risk Chronic Pain Patients on Opioid Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic back pain patients are often dismissed from a pain center or a primary care practice when they are noncompliant with opioid therapy, instead of being offered treatments to reduce misuse and to improve compliance. Unfortunately, there are few treatment resources for such patients. This study seeks to remedy that problem, with the goal of reducing the rate of prescription opioid misuse among noncompliant patients through the use of novel tracking, education, and counseling interventions.
Detailed Description
This study will evaluate drug misuse behavior over 6 months with the use of self-report questionnaires, physician ratings, urine toxicology screens, and electronic diary data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
pain, opioids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-Risk No Treatment
Arm Type
No Intervention
Arm Title
High-Risk Treatment
Arm Type
Experimental
Arm Title
Low-Risk
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioral training
Other Intervention Name(s)
compliance contract, therapy
Intervention Description
electronic diaries, compliance checklists, urine screens, individual and group motivational counseling
Primary Outcome Measure Information:
Title
Drug Misuse Index: 1) physician ratings of misuse (ABC), 2) structured self-report interview (PDUQ), and 3) urine tox screens
Time Frame
All subjects will be followed for 6 months.
Secondary Outcome Measure Information:
Title
1) Rate of patient dismissal from a pain center, 2) treatment satisfaction ratings
Time Frame
Subjects will be followed for 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: chronic pain for >6 months history of taking daily opioids for pain for >6 months average >3 on a pain intensity scale of 0 to 10 over past week able to speak and understand English chronic neck or back pain as primary pain complaint willingness to participate Exclusion Criteria: current opioid addiction (M.I.N.I. Section K) current diagnosis of cancer or any other malignant disease acute osteomyelitis or acute bone disease nonambulatory present or past DSM-IV diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder pregnancy any clinically unstable systemic illness judged to interfere with treatment an acute condition requiring surgery taking opioids intermittently
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert N Jamison, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital Pain Management Center
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19333168
Citation
Wasan AD, Butler SF, Budman SH, Fernandez K, Weiss RD, Greenfield SF, Jamison RN. Does report of craving opioid medication predict aberrant drug behavior among chronic pain patients? Clin J Pain. 2009 Mar-Apr;25(3):193-8. doi: 10.1097/AJP.0b013e318193a6c4.
Results Reference
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PubMed Identifier
18616432
Citation
Wasan AD, Michna E, Janfaza D, Greenfield S, Teter CJ, Jamison RN. Interpreting urine drug tests: prevalence of morphine metabolism to hydromorphone in chronic pain patients treated with morphine. Pain Med. 2008 Oct;9(7):918-23. doi: 10.1111/j.1526-4637.2007.00354.x. Epub 2007 Aug 28.
Results Reference
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PubMed Identifier
18203666
Citation
Butler SF, Fernandez K, Benoit C, Budman SH, Jamison RN. Validation of the revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R). J Pain. 2008 Apr;9(4):360-72. doi: 10.1016/j.jpain.2007.11.014. Epub 2008 Jan 22.
Results Reference
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PubMed Identifier
17877520
Citation
Marceau LD, Link C, Jamison RN, Carolan S. Electronic diaries as a tool to improve pain management: is there any evidence? Pain Med. 2007 Oct;8 Suppl 3:S101-9. doi: 10.1111/j.1526-4637.2007.00374.x.
Results Reference
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PubMed Identifier
17493754
Citation
Butler SF, Budman SH, Fernandez KC, Houle B, Benoit C, Katz N, Jamison RN. Development and validation of the Current Opioid Misuse Measure. Pain. 2007 Jul;130(1-2):144-56. doi: 10.1016/j.pain.2007.01.014. Epub 2007 May 9. Erratum In: Pain. 2009 Mar;142(1-2):169.
Results Reference
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PubMed Identifier
16939853
Citation
Akbik H, Butler SF, Budman SH, Fernandez K, Katz NP, Jamison RN. Validation and clinical application of the Screener and Opioid Assessment for Patients with Pain (SOAPP). J Pain Symptom Manage. 2006 Sep;32(3):287-93. doi: 10.1016/j.jpainsymman.2006.03.010.
Results Reference
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PubMed Identifier
15494186
Citation
Butler SF, Budman SH, Fernandez K, Jamison RN. Validation of a screener and opioid assessment measure for patients with chronic pain. Pain. 2004 Nov;112(1-2):65-75. doi: 10.1016/j.pain.2004.07.026.
Results Reference
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PubMed Identifier
15336337
Citation
Michna E, Ross EL, Hynes WL, Nedeljkovic SS, Soumekh S, Janfaza D, Palombi D, Jamison RN. Predicting aberrant drug behavior in patients treated for chronic pain: importance of abuse history. J Pain Symptom Manage. 2004 Sep;28(3):250-8. doi: 10.1016/j.jpainsymman.2004.04.007.
Results Reference
background
PubMed Identifier
12479253
Citation
Nedeljkovic SS, Wasan A, Jamison RN. Assessment of efficacy of long-term opioid therapy in pain patients with substance abuse potential. Clin J Pain. 2002 Jul-Aug;18(4 Suppl):S39-51. doi: 10.1097/00002508-200207001-00005.
Results Reference
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Substance Abuse Treatment for High Risk Chronic Pain Patients on Opioid Therapy

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