Substance Abuse Treatment for High Risk Chronic Pain Patients on Opioid Therapy - Full Text View

Purpose

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.

Condition	Intervention
Substance Abuse	Behavioral: cognitive behavioral training

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Substance Abuse Treatment for High Risk Chronic Pain Patients on Opioid Therapy

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

1) Rate of patient dismissal from a pain center, 2) treatment satisfaction ratings [ Time Frame: Subjects will be followed for 6 months. ] [ Designated as safety issue: No ]

Estimated Enrollment:	84
Study Start Date:	July 2009
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: High-Risk No Treatment
Experimental: High-Risk Treatment	Behavioral: cognitive behavioral training electronic diaries, compliance checklists, urine screens, individual and group motivational counseling Other Names: compliance contract therapy
No Intervention: Low-Risk

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988962

Locations

United States, Massachusetts
Brigham and Women's Hospital Pain Management Center
Chestnut Hill, Massachusetts, United States, 02467

Sponsors and Collaborators

Brigham and Women's Hospital

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Robert N Jamison, PhD

Brigham and Women's Hospital

More Information

Publications:

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.

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. Epub 2007 Aug 28.

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. Epub 2008 Jan 22.

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.

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. Epub 2007 May 9. Erratum in: Pain. 2009 Mar;142(1-2):169.

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.

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.

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.

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. Review.

Responsible Party:	Robert N. Jamison, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00988962 History of Changes
Other Study ID Numbers:	2007p001732
Study First Received:	September 30, 2009
Last Updated:	June 22, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

pain
opioids

Additional relevant MeSH terms:

Substance-Related Disorders
Mental Disorders
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 16, 2013