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

NCT ID: NCT00988962

Last Updated: 2011-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Substance Abuse

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High-Risk No Treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

High-Risk Treatment

Group Type EXPERIMENTAL

cognitive behavioral training

Intervention Type BEHAVIORAL

electronic diaries, compliance checklists, urine screens, individual and group motivational counseling

Low-Risk

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cognitive behavioral training

electronic diaries, compliance checklists, urine screens, individual and group motivational counseling

Intervention Type BEHAVIORAL

Other Intervention Names

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compliance contract therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Brigham and Women's Hospital

Principal Investigators

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Robert N Jamison, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital Pain Management Center

Chestnut Hill, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19333168 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18616432 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18203666 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17877520 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17493754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16939853 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15494186 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15336337 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12479253 (View on PubMed)

Other Identifiers

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2007p001732

Identifier Type: -

Identifier Source: org_study_id

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